WO2024028793A1

WO2024028793A1 - Bio-based type iir surgical facial mask

Info

Publication number: WO2024028793A1
Application number: PCT/IB2023/057840
Authority: WO
Inventors: Patrice Blanc; Audrey MARTIGNAT; Douglas McKee BENTON
Original assignee: Ahlstrom Oyj
Priority date: 2022-08-02
Filing date: 2023-08-02
Publication date: 2024-02-08

Abstract

Disclosed herein are advantageous facial masks, and related methods of fabrication and use thereof. The present disclosure provides improved facial masks, and improved systems/methods for utilizing and fabricating the facial masks. More particularly, the present disclosure provides advantageous bio-based Type IIR surgical facial masks and related methods of fabrication and use. The present disclosure provides for bio-based facial masks having an exterior layer comprising a first bio-based polymeric non-woven material, a facial layer comprising a second bio-based polymeric non-woven material, the facial layer having a nanofiber coating layer on at least one of an interior surface of the facial layer or a user surface of the facial layer, and a first inner layer comprising a first wet-laid bio-based non-woven material. The first inner layer is positioned between the exterior layer and the facial layer.

Description

BIO-BASED TYPE IIR SURGICAL FACIAL MASK

CROSS-REFERENCE TO RELATED APPLICATION

The present application is an international filing which claims priority to U.S. Provisional Patent Application Number 63/394,403, filed August 2, 2022, which is incorporated herein in its entirety.

FIELD OF THE DISCLOSURE

[0001] The present disclosure relates to facial masks and systems/methods for fabricating and utilizing the facial masks and, more particularly, to bio-based Type IIR surgical facial masks and related methods of fabrication and use.

BACKGROUND OF THE DISCLOSURE

[0002] In general, some facial masks or the like are known. Some conventional practice provides that some material for a filtration layer for a facial mask can include polypropylene (e.g., made by melt-blown technology). Such material could be made by another similar synthetic polymer. Such material is fossil-based, which may not be preferred compared to renewable resources. Also, such material can have limited end-of-life options as the material generally is not compostable, biodegradable, or recyclable (e.g., it only goes to burning).

[0003] Also, such manufacturing processes can have the disadvantages of being slower, with limited production capacity worldwide, which may be a problem (e.g., when the world demand is very high for facial masks).

[0004] An interest exists for improved facial masks, and related methods of fabrication and use.

[0005] These and other inefficiencies and opportunities for improvement are addressed and/or overcome by the facial masks, assemblies and methods of the present disclosure.

BRIEF SUMMARY OF THE DISCLOSURE

[0006] The present disclosure provides advantageous facial masks, and systems/methods for fabricating and utilizing the facial masks.

[0007] More particularly, the present disclosure provides advantageous bio-based Type IIR surgical facial masks and related methods of fabrication and use.

[0008] The above described and other features are exemplified by the following figures and detailed description. [0009] Any combination or permutation of embodiments is envisioned. Additional advantageous features, functions and applications of the disclosed facial masks, assemblies and methods of the present disclosure will be apparent from the description which follows, particularly when read in conjunction with the appended figures. All references listed in this disclosure are hereby incorporated by reference in their entireties.

BRIEF DESCRIPTION OF THE DRAWINGS

[0010] The following figures are exemplary embodiments wherein the like elements are numbered alike.

[0011] Features and aspects of embodiments are described below with reference to the accompanying drawings, in which elements are not necessarily depicted to scale.

[0012] Exemplary embodiments of the present disclosure are further described with reference to the appended figures. It is to be noted that the various features, steps, and combinations of features/steps described below and illustrated in the figures can be arranged and organized differently to result in embodiments which are still within the scope of the present disclosure. To assist those of ordinary skill in the art in making and using the disclosed facial masks, assemblies and methods, reference is made to the appended figures, wherein:

[0013] Figure 1 is an exploded front perspective view of an example facial mask, according to the present disclosure.

[0014] Figure 2 is an exploded cross-sectional side view of the facial mask of FIG. 1.

[0015] Figure 3 is an exploded cross-sectional side view of another example facial mask, according to the present disclosure.

[0016] Figure 4 is an exploded cross-sectional side view of another example facial mask, according to the present disclosure.

[0017] Figure 5 is an exploded cross-sectional side view of another example facial mask, according to the present disclosure.

DETAILED DESCRIPTION OF THE DISCLOSURE

[0018] The exemplary embodiments disclosed herein are illustrative of advantageous facial masks, and systems of the present disclosure and methods/techniques thereof. It should be understood, however, that the disclosed embodiments are merely exemplary of the present disclosure, which may be embodied in various forms. Therefore, details disclosed herein with reference to exemplary facial masks and associated processes/techniques of assembly and use are not to be interpreted as limiting, but merely as the basis for teaching one skilled in the art how to make and use the advantageous facial masks and/or alternative facial masks of the present disclosure.

[0019] Disclosed herein are advantageous facial masks, and related methods of fabrication and use thereof.

[0020] The present disclosure provides improved facial masks, and improved systems/methods for utilizing and fabricating the facial masks.

[0021] More particularly, the present disclosure provides advantageous bio-based Type IIR surgical facial masks and related methods of fabrication and use.

[0022] In the context of the present disclosure, a bio-based facial mask is a facial mask substantially made of renewable raw materials. A “bio-based” product can refer to products that mainly comprise of a substance (or substances) derived from living matter (biomass) and either occur naturally or are synthesized, or it may refer to products made by processes that use biomass. Bio-based products are thus mainly composed of renewable materials. The renewable raw materials content of the bio-based facial mask of the present disclosure can be above 90 wt%, preferably above 95 wt%, and more preferably above 97 or 98 wt%, the weight percentage based on the total weight of the bio-based facial mask.

[0023] Referring now to the drawings, like parts are marked throughout the specification and drawings with the same reference numerals, respectively. Drawing figures are not necessarily to scale and in certain views, parts may have been exaggerated for purposes of clarity.

[0024] As shown in FIG. 1 , there is illustrated an exploded front perspective view of an example facial mask 10 of the present disclosure. FIG. 2 is an exploded cross-sectional side view of the facial mask 10 of FIG. 1.

[0025] In general and as discussed further below, example facial mask 10 includes an exterior layer 12 comprising a first bio-based polymeric non-woven material. The exterior layer 12 is configured to be in contact with an external environment when worn by a user (FIG. 2).

[0026] In certain embodiments, the exterior layer 12 can include an exterior water- repellent coating (e.g., an exterior water-repellent coating comprising a non-fluorinated cationic water-based emulsion).

[0027] Facial mask 10 also includes a facial layer 14 comprising a second bio-based polymeric non-woven material.

[0028] Example facial layer 14 includes a nanofiber coating layer 16 on at least one of an interior surface 13 of the facial layer 14, and/or on a user surface 15 of the facial layer 14 (FIGS. 2 and 3). For example, facial layer 14 can include a nanofiber coating layer 16 on the interior surface 13 of the facial layer 14. In another example, facial layer 14 can include a nanofiber coating layer 16 on the user surface 15 of the facial layer 14. In another example, facial layer 14 can include a first nanofiber coating layer 16 on the interior surface 13, and a second nanofiber coating layer 16 on the user surface 15 of the facial layer 14.

[0029] The facial layer 14 includes the user surface 15, and the user surface 15 is configured to be in contact with a face of the user when worn by the user, and with the interior surface 13 positioned opposite the user surface 15 (FIGS. 2 and 3).

[0030] The total basis weight of each nanofiber coating layer 16 can be greater than zero and less than 1 gram per square meter (gsm), preferably from about 0.2 gsm to about 0.4 gsm.

[0031] Each nanofiber coating layer 16 can comprise a plurality of nanofibers, each nanofiber of the plurality of nanofibers having a nanofiber diameter greater than zero and less than 1 micron.

[0032] Each nanofiber coating layer 16 can comprise biopolyester nanofibers, preferably PL A and/or polyhydroxy alkanoate (PH A) nanofibers.

[0033] Each example facial layer 14 having the at least one nanofiber coating layer 16 can have a differential pressure of less than 25 Pa/cm2 according to the EN 14683:2019, Annex C standard or the ASTM F2100-19 standard, and/or can have a bacterial filtration efficiency (BFE) greater than or equal to 98% according to the European standard EN 14683: 2019, Annex B standard or the standard method ASTM F2100-19 standard, and/or can have a particle filtration efficiency (PFE) greater than or equal to 98% at 0.1 pm measured using 0.1 m aerosolized latex particles.

[0034] Example facial mask 10 also includes at least one inner layer 18. The at least one inner layer 18 of mask 10 of FIGS. 1 and 2 (and each respective inner layer 18 A, 18B, 18C, 18D, discussed below for FIGS. 3-5) comprises a wet-laid bio-based non-woven material. In general and without limitation, each inner layer 18 (and each respective inner layer 18 A, 18B, 18C, 18D) can include a water-repellent coating (e.g., water-repellent bio-based coating; water- repellent bio-based coating having alkyl ketene dimers). Each water-repellent coating can have a wet-strength additive and/or carboxylmethyl cellulose.

[0035] The wet-laid bio-based non-woven material of each inner layer 18 (and each respective inner layer 18 A, 18B, 18C, 18D) can each comprise cellulose fibers. For example, the wet-laid bio-based non-woven material of each inner layer 18, 18A, 18B, 18C, 18D can each comprise 70 wt% cellulose fibers, preferably 80 wt% cellulose fibers, more preferably 100 wt% cellulose fibers, based on the total weight of fibers in the wet-laid bio-based non-woven material of each respective inner layer 18, 18A, 18B, 18C, 18D. [0036] As shown in FIGS. 1 and 2, inner layer 18 is positioned between the exterior layer 12 and the facial layer 14. The total basis weight of the inner layer 18 can be from about 10 gsm to about 50 gsm, preferably from about 12 gsm to about 25 gsm.

[0037] In another embodiment and as shown in FIG. 3, example facial mask 10 includes a first inner layer 18A and a second inner layer 18B, with inner layers 18A, 18B positioned between the exterior layer 12 and the facial layer 14.

[0038] The total basis weight of the first inner layer 18A can be from about 10 gsm to about 50 gsm, preferably from about 12 gsm to about 25 gsm. The total basis weight of the second inner layer 18B can also be from about 10 gsm to about 50 gsm, preferably from about 12 gsm to about 25 gsm.

[0039] The first inner layer 18A can be secured to the second inner layer 18B. For example and without limitation, the first inner layer 18 A can be heat sealed, welded, bonded or glued to the second inner layer 18B, preferably bonded to one another via ultrasonic bonding.

[0040] In other embodiments and as shown in FIG. 4, example facial mask 10 includes a first inner layer 18 A, a second inner layer 18B and a third inner layer 18C, with inner layers 18 A, 18B, 18C positioned between the exterior layer 12 and the facial layer 14.

[0041] The total basis weight of the first inner layer 18A, the second inner layer 18B and third inner layer 18C can each be from about 10 gsm to about 50 gsm, preferably from about 12 gsm to about 25 gsm.

[0042] The first inner layer 18A can be secured to the second inner layer 18B, and the second inner layer 18B can be secured to the third inner layer 18C.

[0043] In another embodiment and as shown in FIG. 5, example facial mask 10 includes a first inner layer 18 A, a second inner layer 18B, a third inner layer 18C, and a fourth inner layer 18D, with inner layers 18A, 18B, 18C, 18D positioned between the exterior layer 12 and the facial layer 14.

[0044] The total basis weight of the first inner layer 18A, the second inner layer 18B, the third inner layer 18C and the fourth inner layer 18D can each be from about 10 gsm to about 50 gsm, preferably from about 12 gsm to about 25 gsm.

[0045] The first inner layer 18A can be secured to the second inner layer 18B, and the second inner layer 18B can be secured to the third inner layer 18C, and the third inner layer 18C can be secured to the fourth inner layer 18D.

[0046] It is noted that example facial mask 10 can include any suitable number of inner layers 18, 18A, 18B, etc. (e.g., one, three, five, seven, a plurality, etc.). [0047] It is noted that the first bio-based polymeric non-woven material of the exterior layer 12 can comprise a spunbond non-woven material or a spunbond-meltblown-spunbond (SMS) non-woven material or a carded material.

[0048] The first bio-based polymeric non-woven material of the exterior layer 12 can comprise a polylactic acid (PLA) spunbond non-woven material or a PLA SMS non-woven material.

[0049] The total basis weight of the first bio-based polymeric non-woven material of the exterior layer 12 can be from about 15 grams per square meter (gsm) to about 40 gsm, preferably from about 18 gsm to about 30 gsm, more preferably 26 gsm.

[0050] It is noted that the second bio-based polymeric non-woven material of the facial layer 14 can comprise a spunbond non-woven material or a spunbond-meltblown-spunbond (SMS) non-woven material.

[0051] The second bio-based polymeric non-woven material of the facial layer 14 can comprise a polylactic acid (PLA) spunbond non-woven material or a PLA SMS non-woven material.

[0052] The total basis weight of the second bio-based polymeric non-woven material of the facial layer 14 can be from about 10 gsm to about 40 gsm, preferably from about 15 gsm to about 26 gsm, more preferably 18 gsm.

[0053] The first and second bio-based polymeric non-woven materials can each comprise biodegradable and/or spinnable fibers. The first and second bio-based polymeric nonwoven materials can each have an air permeability of greater than 1500 L/min/100cm², as measured by ASTM D737.

[0054] The first bio-based polymeric non-woven material of exterior layer 12 can have an air permeability of greater than 2500 L/min/100cm², as measured by ASTM D737.

[0055] The second bio-based polymeric non-woven material of facial layer 14 can have an air permeability of greater than 2700 L/min/100cm², as measured by ASTM D737.

[0056] In example embodiments, the first and second bio-based polymeric non-woven materials are each heat sealable, preferably ultrasonic weldable.

[0057] In example embodiments, the bio-based facial masks 10 of the present disclosure can meet the requirements of European standard EN 14683:2019 for bacterial filtration efficiency for a Type IIR surgical face mask, and the bio-based facial masks 10 can have a bacterial filtration efficiency (BFE) greater than or equal to 98% according to the European standard EN 14683: 2019, Annex B standard or the standard method ASTM F2100-19 standard.

[0058] Moreover, example bio-based facial masks 10 of the present disclosure can meet the requirements of European standard EN 14683:2019 for breathability or pressure differential for a Type IIR surgical face mask, and the bio-based facial masks 10 can have a differential pressure of less than 60 Pa/cm² according to the EN 14683:2019, Annex C standard or the ASTM F2100-19 standard.

[0059] Furthermore, example bio-based facial masks 10 of the present disclosure can meet the requirements of international standard ISO 22609:2004 for splash resistance for a Type IIR surgical face mask, and the bio-based facial masks 10 can have a splash resistance of greater than or equal to 16 kPa according to international standard ISO 22609:2004.

[0060] Additionally, example bio-based facial masks 10 of the present disclosure can meet the requirements of European standard EN ISO11737-l:2018 for microbial cleanliness (bioburden) for a Type IIR surgical face mask, and the bio-based facial masks 10 can have a micro-bacterial cleanliness of less than or equal to 30 cfu/g according to the EN 14683 standard or ISO 11737-1 standard.

[0061] In example embodiments, the bio-based facial masks 10 of the present disclosure can meet the requirements of European standard EN ISO 10993-1:2009 for biocompatibility for a Type IIR surgical face mask.

[0062] Moreover, example bio-based facial masks 10 of the present disclosure can meet the requirements of Level 2 or Level 3 of standard method ASTM F2100-19.

[0063] Example bio-based facial masks 10 of the present disclosure are facial masks 10 substantially made of renewable raw materials. The renewable raw materials content of example bio-based facial masks 10 of the present disclosure can be above 90 wt%, preferably above 95 wt%, and more preferably above 98 wt%, the weight percentage based on the total weight of the bio-based facial mask 10.

[0064] The present disclosure further provides for a method for fabricating a bio-based facial mask 10 including providing an exterior layer 12 comprising a first bio-based polymeric non-woven material, with the exterior layer 12 configured to be in contact with an external environment when worn by a user, and providing a facial layer 14 comprising a second biobased polymeric non-woven material, the facial layer 14 having a nanofiber coating layer 16 on at least one of an interior surface 13 of the facial layer 14 or a user surface 15 of the facial layer 14, and providing at least one inner layer 18 comprising a first wet-laid bio-based non-woven material, each inner layer 18 typically having a first inner water-repellent coating, and positioning each inner layer 18 between the exterior layer 12 and the facial layer 14.

[0065] This disclosure is further illustrated by the following examples, which are non-limiting. EXAMPLES

[0066] Examples.

[0067] For certain example tests, two layers of repellent treated wet-laid bio-based nonwoven materials were tested to get the synthetic blood penetration. By at least two layers, it is meant two or more distinct layers of non-woven which were laminated or glued together.

[0068] The wetaid media comprised primarily cellulose fibers, which were treated with the water-repellent additive. In working examples, each of the layers of the wetlaid media contained 100% cellulose fibers, based on the total weight of fibers in each layer.

[0069] The wetlaid should be water-repellent in order to be splash-resistant. The water- repellent was added as a coating - the water-repellent treatment used in these working examples was Hereon AKD, which is biobased and is modified/obtained from natural sources. Additionally, the wetlaid coating also contained a wet-strength additive (Kymene) and CMC (carboxylmethyl cellulose).

[0070] Water repellency of the wetlaid layers were tested by checking how long it took for the material to absorb synthetic blood droplets at 85% relative humidity - if the blood droplets remained beaded on the surface for the duration of the test (300s), then the material was considered to have suitable repellency.

[0071] The mask can be made such that the nanofiber layer is oriented closer towards the face; otherwise the mask material can delaminate from the spray force and may not pass the blood penetration test (e.g., the nanofiber layer may not be bonded too strongly, so it may delaminate).

[0072] The nano-coating can be tested and optimized for improved/maximum breathability. The nano-coating can be very low weight (e.g., less than Igsm, about 0.2 to 0.4gsm), which may not be accurately measured when one takes apart the finished product. It may be better to characterize the nanofiber layer by its fiber diameter (e.g., less than 1 micron) or by the differential pressure obtained by the nano-coated PLA.

[0073] A nano-coated PLA with differential pressure below 25Pa, with greater than 98% bacterial filtration efficiency and greater than 98% particle filtration efficiency was evaluated.

[0074] The polymer used for the spunbond can be any biobased, biodegradable and a spinnable fiber.

[0075] Air permeability of the PLA layer should be greater than 1500 L/min/100cm², as measured by ASTM D737. For example, the 26gsm PLA spunbond layer in the working examples was 2500 L/min/100cm² while the 18gsm PLA layer was 2800 L/min/100cm².

[0076] The spunbond in general is less than 35g/m², with lighter grammages (e.g. 18gsm) preferred on the inside (e.g., close to face) and heavier spunbond on outside. [0077] The PLA layer is preferably repellent treated so it adds splash resistance. A biobased water-repellent, Daikin Unidyne XF-5005, was used in the working examples.

Table 1: Water Repellency results - Synthetic Blood Droplet Absorption with conditioning for the wetlaid and spunbond layers (85% relative humidity is required conditioning for facemasks):

[0078] As can be seen from the droplet absorption times at 85% RH, the synthetic blood droplets remained beaded up on the surface of the nonwoven media which contained water repellent additives throughout the duration of the test (5 minutes).

[0079] This indicates that the facemasks made with the repellent coating will be more splash-resistant and less likely to absorb any blood splatters. The repellent treatment may be needed for the cellulosic layer; preferably a repellent may also be coated onto to the outer spunbond layer of the mask for improved/optimal splash resistance.

Classification of medical face masks according to ASTM F2100 and EN 14683 : [0080] Some key parameters used in these standards are the following. Bacterial filtration efficiency (BFE) - measures the efficiency of the medical face mask material(s) as a barrier to bacterial penetration. Particle filtration efficiency (PFE) - measures the efficiency of the medical face mask material(s) as a barrier to submicron particles penetration. Differential pressure - measures the breathability of the face mask by determining the difference of pressure across the mask under specific conditions of air flow, temperature and humidity. Splash resistance - measures ability of medical face mask to withstand penetration of synthetic blood projected at a given pressure. “R” stands for splash resistance. Microbial cleanliness - measures freedom from population of viable micro-organisms on a product and/or a package.

Table 2:

[0081] Comparative example 1 : Polypropylene based Synthetic Medical Facemask. This is a three layer polypropylene spunbond/meltblown/spunbond (SMS) structure.

[0082] Comparative example 2: Biobased Medical Facemask design with Nano filter layer (composed of PHA/PLA nanofibers) and PLA spunbond for outer and inner layers.

[0083] Comparative example 3: Biobased Medical Facemask design with Nano filter layer and PLA spunbond for outer and inner layers, and an intermediate wet-laid cellulosic layer without repellency treatment.

[0084] Comparative example 4: Biobased Medical Facemask design with Nano filter layer and PLA spunbond for outer and inner layers, and an intermediate wet-laid cellulosic layer with repellency treatment. [0085] Example 1: Biobased Medical Facemask design with Nano filter layer and PLA spunbond outer and inner layers, and two intermediate wet-laid cellulosic layers with water repellency treatment.

[0086] Example 2: Biobased Medical Facemask design with Nano filter layer and PLA spunbond for outer and inner layers, and three intermediate wet-laid cellulosic layers with repellency treatment. The outer PLA layer has also a water repellency treatment.

[0087] Example 3: Biobased Medical Facemask design with Nano filter layer and PLA spunbond with water repellency treatment for outer and inner layers, and four intermediate wet- laid cellulosic layers with repellency treatment. The outer PLA layer has also a water repellency treatment.

Table 3:

[0088] This table shows that conventional PLA based facemasks (comparative example 2) have no splash resistance and out the 32 test none has passed. Adding a cellulosic wet-laid media does not improve the splash resistance (Comparative example 3). Having a cellulosic wet-laid with a repellency treatment improves the splash resistance because 18 out of 32 tests passed. When two cellulosic wet-laid medias were used the splash resistance improved significantly and passed the splash resistance test. Adding more wet-laid cellulosic layers (example 2 and 3) with repellency treatment also have sufficient splash resistance without adversely affecting the breathability (differential pressure) of the facemask. The PLA spundbond of the outer layer can have a water repellency treatment to further improve the splash resistance of the facemask.

[0089] This disclosure further encompasses the following aspects.

[0090] Aspect 1. A bio-based facial mask comprising an exterior layer comprising a first bio-based polymeric non-woven material, the exterior layer configured to be in contact with an external environment when worn by a user; a facial layer comprising a second bio-based polymeric non-woven material, the facial layer having a nanofiber coating layer on at least one of an interior surface of the facial layer or a user surface of the facial layer, with the facial layer having the user surface configured to be in contact with a face of the user when worn by the user, the interior surface positioned opposite the user surface; a first inner layer comprising a first wet-laid bio-based non-woven material, the first inner layer having a first inner water- repellent coating; and wherein the first inner layer is positioned between the exterior layer and the facial layer.

[0091] Aspect 2. The bio-based facial mask of Aspect 1 further comprising a second inner layer comprising a second wet-laid bio-based non-woven material, the second inner layer having a second inner water-repellent coating; wherein the first and second inner layers are positioned between the exterior layer and the facial layer.

[0092] Aspect 3. The bio-based facial mask of any one or more of the preceding aspects, wherein the exterior layer includes an exterior water-repellent coating.

[0093] Aspect 4. The bio-based facial mask of any one or more of the preceding aspects, wherein the bio-based facial mask meets the requirements of European standard EN 14683:2019 for bacterial filtration efficiency for a Type IIR surgical face mask, and the bio-based facial mask has a bacterial filtration efficiency (BFE) greater than or equal to 98% according to the European standard EN 14683: 2019, Annex B standard or the standard method ASTM F2100-19 standard.

[0094] Aspect 5. The bio-based facial mask of any one or more of the preceding aspects, wherein the bio-based facial mask meets the requirements of European standard EN 14683:2019 for breathability or pressure differential for a Type IIR surgical face mask, and the bio-based facial mask has a differential pressure of less than 60 Pa/cm² according to the EN 14683:2019, Annex C standard or the ASTM F2100-19 standard.

[0095] Aspect 6. The bio-based facial mask of any one or more of the preceding aspects, wherein the bio-based facial mask meets the requirements of international standard ISO 22609:2004 for splash resistance for a Type IIR surgical face mask, and the bio-based facial mask has a splash resistance of greater than or equal to 16 kPa according to international standard ISO 22609:2004. [0096] Aspect 7. The bio-based facial mask of any one or more of the preceding aspects, wherein the bio-based facial mask meets the requirements of European standard EN ISO11737- 1:2018 for microbial cleanliness (bioburden) for a Type IIR surgical face mask, and bio-based facial mask has a micro-bacterial cleanliness of less than or equal to 30 cfu/g according to the EN 14683 standard or ISO 11737-1 standard.

[0097] Aspect 8. The bio-based facial mask of any one or more of the preceding aspects, wherein the bio-based facial mask meets the requirements of European standard EN ISO 10993- 1:2009 for biocompatibility for a Type IIR surgical face mask.

[0098] Aspect 9. The bio-based facial mask of any one or more of the preceding aspects, wherein the bio-based facial mask meets the requirements of Level 2 or Level 3 of standard method ASTM F2100-19.

[0099] Aspect 10. The bio-based facial mask of any one or more of the preceding aspects, wherein the first bio-based polymeric non-woven material comprises a spunbond nonwoven material or a spunbond-meltblown- spunbond (SMS) non-woven material or a carded material; and wherein the second bio-based polymeric non-woven material comprises a spunbond non-woven material or a spunbond-meltblown-spunbond (SMS) non-woven material.

[0100] Aspect 11. The bio-based facial mask of any one or more of the preceding aspects, wherein the first bio-based polymeric non-woven material comprises a polylactic acid (PL A) spunbond non-woven material or a PLA SMS non-woven material; and wherein the second bio-based polymeric non-woven material comprises a polylactic acid (PLA) spunbond non-woven material or a PLA SMS non-woven material.

[0101] Aspect 12. The bio-based facial mask of any one or more of the preceding aspects, wherein the total basis weight of the first bio-based polymeric non-woven material is from about 15 grams per square meter (gsm) to about 40 gsm, preferably from about 18 gsm to about 30 gsm, more preferably 26 gsm.

[0102] Aspect 13. The bio-based facial mask of any one or more of the preceding aspects, wherein the total basis weight of the second bio-based polymeric non-woven material is from about 10 gsm to about 40 gsm, preferably from about 15 gsm to about 26 gsm, more preferably 18 gsm.

[0103] Aspect 14. The bio-based facial mask of any one or more of the preceding aspects, wherein the total basis weight of the first inner layer is from about 10 gsm to about 50 gsm, preferably from about 12 gsm to about 25 gsm.

[0104] Aspect 15. The bio-based facial mask of Aspect 2, wherein the total basis weight of the second inner layer is from about 10 gsm to about 50 gsm, preferably from about 12 gsm to about 25 gsm. [0105] Aspect 16. The bio-based facial mask of Aspect 2, further comprising at least one additional inner layer, each additional inner layer comprising a wet-laid bio-based nonwoven material.

[0106] Aspect 17. The bio-based facial mask of Aspect 16, wherein each additional inner layer is positioned between the first and second inner layers.

[0107] Aspect 18. The bio-based facial mask of Aspect 16, wherein the total basis weight of each additional inner layer is from about 10 gsm to about 50 gsm, preferably from about 12 gsm to about 25 gsm.

[0108] Aspect 19. The bio-based facial mask of Aspect 16, wherein each additional inner layer includes a water-repellent coating.

[0109] Aspect 20. The bio-based facial mask of Aspect 16, wherein each additional inner layer includes a water-repellent bio-based coating.

[0110] Aspect 21. The bio-based facial mask of Aspect 2, wherein the first inner layer is positioned proximal to the exterior layer, and the second inner layer is positioned proximal to the facial layer.

[0111] Aspect 22. The bio-based facial mask of Aspect 2, wherein the first inner layer is secured to the second inner layer.

[0112] Aspect 23. The bio-based facial mask of Aspect 2, wherein the first inner layer is heat sealed, welded, bonded or glued to the second inner layer, preferably bonded via ultrasonic bonding.

[0113] Aspect 24. The bio-based facial mask of Aspect 2, wherein the first and second wet-laid bio-based non-woven materials each comprise cellulose fibers.

[0114] Aspect 25. The bio-based facial mask of Aspect 2, wherein the first and second wet-laid bio-based non-woven materials each comprise 70 wt% cellulose fibers, preferably 80 wt% cellulose fibers, more preferably 100 wt% cellulose fibers, based on the total weight of fibers in each respective first and second wet-laid bio-based non-woven materials.

[0115] Aspect 26. The bio-based facial mask of Aspect 2, wherein the first and second inner layers include first and second water-repellent bio-based coatings having alkyl ketene dimers.

[0116] Aspect 27. The bio-based facial mask of Aspect 2, wherein the first and second inner layers include first and second water-repellent bio-based coatings having a wet-strength additive and carboxylmethyl cellulose.

[0117] Aspect 28. The bio-based facial mask of Aspect 3, wherein the exterior water- repellent coating comprises a non-fluorinated cationic water-based emulsion. [0118] Aspect 29. The bio-based facial mask of any one or more of the preceding aspects, wherein the total basis weight of the nanofiber coating layer is greater than zero and less than 1 gsm, preferably from about 0.2 gsm to about 0.4 gsm.

[0119] Aspect 30. The bio-based facial mask of any one or more of the preceding aspects, wherein the nanofiber coating layer comprises a plurality of nanofibers, each nanofiber of the plurality of nanofibers having a nanofiber diameter greater than zero and less than 1 micron.

[0120] Aspect 31. The bio-based facial mask of any one or more of the preceding aspects, wherein the facial layer having the nanofiber coating layer has a differential pressure of less than 25 Pa/cm2 according to the EN 14683:2019, Annex C standard or the ASTM F2100-19 standard, and has a bacterial filtration efficiency (BFE) greater than or equal to 98% according to the European standard EN 14683: 2019, Annex B standard or the standard method ASTM F2100-19 standard, and has a particle filtration efficiency (PFE) greater than or equal to 98% at 0.1 pm measured using 0.1 pm aerosolized latex particles.

[0121] Aspect 32. The bio-based facial mask of any one or more of the preceding aspects, wherein the first and second bio-based polymeric non-woven materials each comprise biodegradable and/or spinnable fibers.

[0122] Aspect 33. The bio-based facial mask of any one or more of the preceding aspects, wherein the first and second bio-based polymeric non-woven materials each have an air permeability of greater than 1500 L/min/100cm², as measured by ASTM D737.

[0123] Aspect 34. The bio-based facial mask of any one or more of the preceding aspects, wherein the first bio-based polymeric non-woven material has an air permeability of greater than 2500 L/min/100cm², as measured by ASTM D737.

[0124] Aspect 35. The bio-based facial mask of any one or more of the preceding aspects, wherein the second bio-based polymeric non-woven material has an air permeability of greater than 2700 L/min/100cm², as measured by ASTM D737.

[0125] Aspect 36. The bio-based facial mask of any one or more of the preceding aspects, wherein the nanofiber coating layer comprises biopolyester nanofibers, preferably PL A and/or polyhydroxy alkanoate (PH A) nanofibers.

[0126] Aspect 37. The bio-based facial mask of any one or more of the preceding aspects, wherein the first and second bio-based polymeric non-woven materials are each heat sealable, preferably ultrasonic weldable.

[0127] Aspect 38. A method for fabricating a bio-based facial mask comprising providing an exterior layer comprising a first bio-based polymeric non-woven material, the exterior layer configured to be in contact with an external environment when worn by a user; providing a facial layer comprising a second bio-based polymeric non-woven material, the facial layer having a nanofiber coating layer on at least one of an interior surface of the facial layer or a user surface of the facial layer, with the facial layer having the user surface configured to be in contact with a face of the user when worn by the user, the interior surface positioned opposite the user surface; providing a first inner layer comprising a first wet-laid bio-based non-woven material, the first inner layer having a first inner water-repellent coating; and positioning the first inner layer between the exterior layer and the facial layer.

[0128] Aspect 39. The method of Aspect 38 further comprising providing a second inner layer comprising a second wet-laid bio-based non-woven material, the second inner layer having a second inner water-repellent coating; wherein the first and second inner layers are positioned between the exterior layer and the facial layer.

[0129] Aspect 40. The method of any one of Aspect 38 or Aspect 39, wherein the exterior layer includes an exterior water-repellent coating.

[0130] Aspect 41. The method of any one of Aspects 38 to 40, wherein the bio-based facial mask meets the requirements of European standard EN 14683:2019 for bacterial filtration efficiency for a Type IIR surgical face mask, and the bio-based facial mask has a bacterial filtration efficiency (BFE) greater than or equal to 98% according to the European standard EN 14683: 2019, Annex B standard or the standard method ASTM F2100-19 standard; and wherein the bio-based facial mask meets the requirements of European standard EN 14683:2019 for breathability or pressure differential for a Type IIR surgical face mask, and the bio-based facial mask has a differential pressure of less than 60 Pa/cm² according to the EN 14683:2019, Annex C standard or the ASTM F2100-19 standard; and wherein the bio-based facial mask meets the requirements of international standard ISO 22609:2004 for splash resistance for a Type IIR surgical face mask, and the bio-based facial mask has a splash resistance of greater than or equal to 16 kPa according to international standard ISO 22609:2004; and wherein the bio-based facial mask meets the requirements of European standard EN ISO11737-l:2018 for microbial cleanliness (bioburden) for a Type IIR surgical face mask, and bio-based facial mask has a micro-bacterial cleanliness of less than or equal to 30 cfu/g according to the EN 14683 standard or ISO 11737-1 standard; and wherein the bio-based facial mask meets the requirements of European standard EN ISO 10993-1:2009 for biocompatibility for a Type IIR surgical face mask.

[0131] Aspect 42. The method of any one of Aspect 38 to Aspect 41, wherein the first bio-based polymeric non-woven material comprises a polylactic acid (PLA) spunbond nonwoven material or a PLA SMS non-woven material; and wherein the second bio-based polymeric non-woven material comprises a polylactic acid (PLA) spunbond non-woven material or a PLA SMS non-woven material.

[0132] Aspect 43. The method of Aspect 39 further comprising at least one additional inner layer, each additional inner layer comprising a wet-laid bio-based non-woven material, with each additional inner layer positioned between the first and second inner layers.

[0133] Aspect 44. The method of Aspect 39, wherein the first inner layer is positioned proximal to the exterior layer, and the second inner layer is positioned proximal to the facial layer.

[0134] Aspect 45. The method of Aspect 39, wherein the first inner layer is secured to the second inner layer.

[0135] Aspect 46. The method of any one of Aspects 38 to 45, wherein the first and second wet-laid bio-based non-woven materials each comprise cellulose fibers.

[0136] Aspect 47. The method of any one of Aspects 38 to 46, wherein the total basis weight of the nanofiber coating layer is greater than zero and less than 1 gsm, preferably from about 0.2 gsm to about 0.4 gsm.

[0137] Aspect 48. The method of any one of Aspects 38 to 47, wherein the nanofiber coating layer comprises a plurality of nanofibers, each nanofiber of the plurality of nanofibers having a nanofiber diameter greater than zero and less than 1 micron.

[0138] While particular embodiments have been described, alternatives, modifications, variations, improvements, and substantial equivalents that are or may be presently unforeseen may arise to applicants or others skilled in the art. Accordingly, the appended claims as filed and as they may be amended are intended to embrace all such alternatives, modifications variations, improvements, and substantial equivalents.

[0139] All ranges disclosed herein are inclusive of the endpoints, and the endpoints are independently combinable with each other (e.g., ranges of “up to 25 wt.%, or, more specifically, 5 wt.% to 20 wt.%”, is inclusive of the endpoints and all intermediate values of the ranges of “5 wt.% to 25 wt.%,” etc.). “Combinations” is inclusive of blends, mixtures, alloys, reaction products, and the like. The terms “first,” “second,” and the like, do not denote any order, quantity, or importance, but rather are used to distinguish one element from another. The terms “a” and “an” and “the” do not denote a limitation of quantity and are to be construed to cover both the singular and the plural, unless otherwise indicated herein or clearly contradicted by context. “Or” means “and/or” unless clearly stated otherwise. Reference throughout the specification to “some embodiments”, “an embodiment”, and so forth, means that a particular element described in connection with the embodiment is included in at least one embodiment described herein, and may or may not be present in other embodiments. In addition, it is to be understood that the described elements may be combined in any suitable manner in the various embodiments. A “combination thereof’ is open and includes any combination comprising at least one of the listed components or properties optionally together with a like or equivalent component or property not listed.

[0140] Unless defined otherwise, technical and scientific terms used herein have the same meaning as is commonly understood by one of skill in the art to which this application belongs. All cited patents, patent applications, and other references are incorporated herein by reference in their entirety. However, if a term in the present application contradicts or conflicts with a term in the incorporated reference, the term from the present application takes precedence over the conflicting term from the incorporated reference.

[0141] Unless specified to the contrary herein, all test standards are the most recent standard in effect as of the filing date of this application, or, if priority is claimed, the filing date of the earliest priority application in which the test standard appears.

[0142] Although the facial masks, systems and methods of the present disclosure have been described with reference to exemplary embodiments thereof, the present disclosure is not limited to such exemplary embodiments and/or implementations. Rather, the facial masks, systems and methods of the present disclosure are susceptible to many implementations and applications, as will be readily apparent to persons skilled in the art from the disclosure hereof. The present disclosure expressly encompasses such modifications, enhancements and/or variations of the disclosed embodiments. Since many changes could be made in the above construction and many widely different embodiments of this disclosure could be made without departing from the scope thereof, it is intended that all matter contained in the drawings and specification shall be interpreted as illustrative and not in a limiting sense. Additional modifications, changes, and substitutions are intended in the foregoing disclosure. Accordingly, it is appropriate that the appended claims be construed broadly and in a manner consistent with the scope of the disclosure.

Claims

CLAIMS What is claimed is:

1. A bio-based facial mask comprising: an exterior layer comprising a first bio-based polymeric non-woven material, the exterior layer configured to be in contact with an external environment when worn by a user; a facial layer comprising a second bio-based polymeric non-woven material, the facial layer having a nanofiber coating layer on at least one of an interior surface of the facial layer or a user surface of the facial layer, with the facial layer having the user surface configured to be in contact with a face of the user when worn by the user, the interior surface positioned opposite the user surface; a first inner layer comprising a first wet-laid bio-based non-woven material, the first inner layer having a first inner water-repellent coating; and wherein the first inner layer is positioned between the exterior layer and the facial layer.

2. The bio-based facial mask of Claim 1 further comprising a second inner layer comprising a second wet-laid bio-based non-woven material, the second inner layer having a second inner water-repellent coating; wherein the first and second inner layers are positioned between the exterior layer and the facial layer.

3. The bio-based facial mask of any one or more of the preceding claims, wherein the exterior layer includes an exterior water-repellent coating.

4. The bio-based facial mask of any one or more of the preceding claims, wherein the bio-based facial mask meets the requirements of European standard EN 14683:2019 for bacterial filtration efficiency for a Type IIR surgical face mask, and the bio-based facial mask has a bacterial filtration efficiency (BFE) greater than or equal to 98% according to the European standard EN 14683: 2019, Annex B standard or the standard method ASTM F2100-19 standard.

5. The bio-based facial mask of any one or more of the preceding claims, wherein the bio-based facial mask meets the requirements of European standard EN 14683:2019 for breathability or pressure differential for a Type IIR surgical face mask, and the bio-based facial mask has a differential pressure of less than 60 Pa/cm² according to the EN 14683:2019, Annex C standard or the ASTM F2100-19 standard.

6. The bio-based facial mask of any one or more of the preceding claims, wherein the bio-based facial mask meets the requirements of international standard ISO 22609:2004 for splash resistance for a Type IIR surgical face mask, and the bio-based facial mask has a splash resistance of greater than or equal to 16 kPa according to international standard ISO 22609:2004.

7. The bio-based facial mask of any one or more of the preceding claims, wherein the bio-based facial mask meets the requirements of European standard EN ISO11737-1:2018 for microbial cleanliness (bioburden) for a Type IIR surgical face mask, and bio-based facial mask has a micro-bacterial cleanliness of less than or equal to 30 cfu/g according to the EN 14683 standard or ISO 11737-1 standard.

8. The bio-based facial mask of any one or more of the preceding claims, wherein the bio-based facial mask meets the requirements of European standard EN ISO 10993-1:2009 for biocompatibility for a Type IIR surgical face mask.

9. The bio-based facial mask of any one or more of the preceding claims, wherein the bio-based facial mask meets the requirements of Level 2 or Level 3 of standard method ASTM F2100-19.

10. The bio-based facial mask of any one or more of the preceding claims, wherein the first bio-based polymeric non-woven material comprises a spunbond non-woven material or a spunbond-meltblown-spunbond (SMS) non-woven material or a carded material; and wherein the second bio-based polymeric non-woven material comprises a spunbond nonwoven material or a spunbond-meltblown-spunbond (SMS) non-woven material.

11. The bio-based facial mask of any one or more of the preceding claims, wherein the first bio-based polymeric non-woven material comprises a polylactic acid (PLA) spunbond non-woven material or a PLA SMS non-woven material; and wherein the second bio-based polymeric non-woven material comprises a polylactic acid (PLA) spunbond non-woven material or a PLA SMS non-woven material.

12. The bio-based facial mask of any one or more of the preceding claims, wherein the total basis weight of the first bio-based polymeric non-woven material is from about 15 grams per square meter (gsm) to about 40 gsm, preferably from about 18 gsm to about 30 gsm, more preferably 26 gsm.

13. The bio-based facial mask of any one or more of the preceding claims, wherein the total basis weight of the second bio-based polymeric non-woven material is from about 10 gsm to about 40 gsm, preferably from about 15 gsm to about 26 gsm, more preferably 18 gsm.

14. The bio-based facial mask of any one or more of the preceding claims, wherein the total basis weight of the first inner layer is from about 10 gsm to about 50 gsm, preferably from about 12 gsm to about 25 gsm.

15. The bio-based facial mask of Claim 2, wherein the total basis weight of the second inner layer is from about 10 gsm to about 50 gsm, preferably from about 12 gsm to about 25 gsm.

16. The bio-based facial mask of Claim 2, further comprising at least one additional inner layer, each additional inner layer comprising a wet-laid bio-based non-woven material.

17. The bio-based facial mask of Claim 16, wherein each additional inner layer is positioned between the first and second inner layers.

18. The bio-based facial mask of Claim 16, wherein the total basis weight of each additional inner layer is from about 10 gsm to about 50 gsm, preferably from about 12 gsm to about 25 gsm.

19. The bio-based facial mask of Claim 16, wherein each additional inner layer includes a water-repellent coating.

20. The bio-based facial mask of Claim 16, wherein each additional inner layer includes a water-repellent bio-based coating.

21. The bio-based facial mask of Claim 2, wherein the first inner layer is positioned proximal to the exterior layer, and the second inner layer is positioned proximal to the facial layer.

22. The bio-based facial mask of Claim 2, wherein the first inner layer is secured to the second inner layer.

23. The bio-based facial mask of Claim 2, wherein the first inner layer is heat sealed, welded, bonded or glued to the second inner layer, preferably bonded via ultrasonic bonding.

24. The bio-based facial mask of Claim 2, wherein the first and second wet-laid biobased non-woven materials each comprise cellulose fibers.

25. The bio-based facial mask of Claim 2, wherein the first and second wet-laid biobased non-woven materials each comprise 70 wt% cellulose fibers, preferably 80 wt% cellulose fibers, more preferably 100 wt% cellulose fibers, based on the total weight of fibers in each respective first and second wet-laid bio-based non-woven materials.

26. The bio-based facial mask of Claim 2, wherein the first and second inner layers include first and second water-repellent bio-based coatings having alkyl ketene dimers.

27. The bio-based facial mask of Claim 2, wherein the first and second inner layers include first and second water-repellent bio-based coatings having a wet-strength additive and carboxylmethyl cellulose.

28. The bio-based facial mask of Claim 3, wherein the exterior water-repellent coating comprises a non-fluorinated cationic water-based emulsion.

29. The bio-based facial mask of any one or more of the preceding claims, wherein the total basis weight of the nanofiber coating layer is greater than zero and less than 1 gsm, preferably from about 0.2 gsm to about 0.4 gsm.

30. The bio-based facial mask of any one or more of the preceding claims, wherein the nanofiber coating layer comprises a plurality of nanofibers, each nanofiber of the plurality of nanofibers having a nanofiber diameter greater than zero and less than 1 micron.

31. The bio-based facial mask of any one or more of the preceding claims, wherein the facial layer having the nanofiber coating layer has a differential pressure of less than 25 Pa/cm2 according to the EN 14683:2019, Annex C standard or the ASTM F2100-19 standard, and has a bacterial filtration efficiency (BFE) greater than or equal to 98% according to the European standard EN 14683: 2019, Annex B standard or the standard method ASTM F2100-19 standard, and has a particle filtration efficiency (PFE) greater than or equal to 98% at 0.1 pm measured using 0.1 m aerosolized latex particles.

32. The bio-based facial mask of any one or more of the preceding claims, wherein the first and second bio-based polymeric non-woven materials each comprise biodegradable and/or spinnable fibers.

33. The bio-based facial mask of any one or more of the preceding claims, wherein the first and second bio-based polymeric non-woven materials each have an air permeability of greater than 1500 L/min/100cm², as measured by ASTM D737.

34. The bio-based facial mask of any one or more of the preceding claims, wherein the first bio-based polymeric non-woven material has an air permeability of greater than 2500 L/min/100cm², as measured by ASTM D737.

35. The bio-based facial mask of any one or more of the preceding claims, wherein the second bio-based polymeric non-woven material has an air permeability of greater than 2700 L/min/100cm², as measured by ASTM D737.

36. The bio-based facial mask of any one or more of the preceding claims, wherein the nanofiber coating layer comprises biopolyester nanofibers, preferably PLA and/or polyhydroxy alkanoate (PH A) nanofibers.

37. The bio-based facial mask of any one or more of the preceding claims, wherein the first and second bio-based polymeric non-woven materials are each heat sealable, preferably ultrasonic weldable.

38. A method for fabricating a bio-based facial mask comprising: providing an exterior layer comprising a first bio-based polymeric non-woven material, the exterior layer configured to be in contact with an external environment when worn by a user; providing a facial layer comprising a second bio-based polymeric non-woven material, the facial layer having a nanofiber coating layer on at least one of an interior surface of the facial layer or a user surface of the facial layer, with the facial layer having the user surface configured to be in contact with a face of the user when worn by the user, the interior surface positioned opposite the user surface; providing a first inner layer comprising a first wet-laid bio-based non-woven material, the first inner layer having a first inner water-repellent coating; and positioning the first inner layer between the exterior layer and the facial layer.

39. The method of Claim 38 further comprising providing a second inner layer comprising a second wet-laid bio-based non-woven material, the second inner layer having a second inner water-repellent coating; wherein the first and second inner layers are positioned between the exterior layer and the facial layer.

40. The method of any one of Claim 38 or Claim 39, wherein the exterior layer includes an exterior water-repellent coating.

41. The method of any one of Claims 38 to 40, wherein the bio-based facial mask meets the requirements of European standard EN 14683:2019 for bacterial filtration efficiency for a Type IIR surgical face mask, and the bio-based facial mask has a bacterial filtration efficiency (BFE) greater than or equal to 98% according to the European standard EN 14683: 2019, Annex B standard or the standard method ASTM F2100-19 standard; and wherein the bio-based facial mask meets the requirements of European standard EN 14683:2019 for breathability or pressure differential for a Type IIR surgical face mask, and the bio-based facial mask has a differential pressure of less than 60 Pa/cm² according to the EN 14683:2019, Annex C standard or the ASTM F2100-19 standard; wherein the bio-based facial mask meets the requirements of international standard ISO 22609:2004 for splash resistance for a Type IIR surgical face mask, and the bio-based facial mask has a splash resistance of greater than or equal to 16 kPa according to international standard ISO 22609:2004; and wherein the bio-based facial mask meets the requirements of European standard EN ISO11737-1:2018 for microbial cleanliness (bioburden) for a Type IIR surgical face mask, and bio-based facial mask has a micro-bacterial cleanliness of less than or equal to 30 cfu/g according to the EN 14683 standard or ISO 11737-1 standard; and wherein the bio-based facial mask meets the requirements of European standard EN ISO 10993-1:2009 for biocompatibility for a Type IIR surgical face mask.

42. The method of any one of Claims 38 to Claim 41, wherein the first bio-based polymeric non-woven material comprises a polylactic acid (PLA) spunbond non-woven material or a PLA SMS non-woven material; and wherein the second bio-based polymeric non-woven material comprises a polylactic acid (PLA) spunbond non-woven material or a PLA SMS non-woven material.

43. The method of Claim 39 further comprising at least one additional inner layer, each additional inner layer comprising a wet-laid bio-based non-woven material, with each additional inner layer positioned between the first and second inner layers.

44. The method of Claim 39, wherein the first inner layer is positioned proximal to the exterior layer, and the second inner layer is positioned proximal to the facial layer.

45. The method of Claim 39, wherein the first inner layer is secured to the second inner layer.

46. The method of any one of Claims 38 to 45, wherein the first and second wet-laid bio-based non-woven materials each comprise cellulose fibers.

47. The method of any one of Claims 38 to 46, wherein the total basis weight of the nanofiber coating layer is greater than zero and less than 1 gsm, preferably from about 0.2 gsm to about 0.4 gsm.

48. The method of any one of Claims 38 to 47, wherein the nanofiber coating layer comprises a plurality of nanofibers, each nanofiber of the plurality of nanofibers having a nanofiber diameter greater than zero and less than 1 micron.