US20220400786A1

US20220400786A1 - Protective mask

Info

Publication number: US20220400786A1
Application number: US17/349,911
Authority: US
Inventors: Christopher T. Ellerbrake
Original assignee: Individual
Current assignee: Individual
Priority date: 2021-06-17
Filing date: 2021-06-17
Publication date: 2022-12-22
Also published as: WO2022266558A3; WO2022266558A2

Abstract

The present invention provides a protective face mask comprising an inner mask layer, an outer mask layer and a foam frame disposed between the respective mask layers. Two opposing elastic ear straps are configured to loop around the wearer's ears to secure the protective mask to the wearer's face and the resultant tension directs pressure through the foam frame and exerts force to press the inner mask or a filtration material layer against the wearer's face, thus creating an effective seal. The inner and outer mask layers, and the foam frame positioned therebetween, provide enhanced protection from potentially harmful airborne pathogens and provide a barrier to undesirable fluid, aerosol and particulate transfer

Description

STATEMENT REGARDING FEDERALLY SPONSORED RESEARCH OR DEVELOPMENT

The present invention was made with no government support.

RELATED PATENT APPLICATIONS AND INCORPORATION BY REFERENCE

Not applicable

FIELD OF THE INVENTION

The present invention is directed generally to disposable protective masks. More specifically, the present invention is directed to a unique single layer or multi-layer mask for everyday use by the general public and hospitality industry as well as for use by medical professionals, such as surgeons and nurses, dental professionals and other healthcare professions. The present invention covers the mouth and nose portions of the wearer's face and serves to protect its wearer and those in close proximity to the wearer from exposure to airborne, liquid or solid contaminants, which may contain pathogens or carcinogens. The present invention utilizes a unique seal assist component (a foam frame) and a method of utilizing that component in order to greatly improve the efficiency and comfort of the face mask resulting in a reduction of communicable disease propagation, inhalation and exposure to foreign particulate matter, thereby preventing illness.

BACKGROUND OF THE INVENTION

Protection of individuals in all walks of life is vital. Pandemics such as influenza and COVID-19 pose an even more dangerous threat, thus heightening the need for more efficient protection, such as improved masks designed to protect individuals from the transfer of harmful microorganisms, bodily fluids and particulate material. Pathogens, carcinogens, toxins, fine particulate matter and allergens can be found airborne in all medical workplaces, hobby shops, homes, outdoors and in most other environments. The effectiveness and successful deployment of protective masks depends upon several factors, including fit, comfort, efficacy, ease of manufacture, durability and cost. Traditional face masks have many drawbacks, including causing discomfort and disturbing a wearer's ability to breathe, slipping out of place, fogging eyewear and failing to achieve an adequate seal with the face, thus rendering them largely ineffective as an air filter. Also much of the potentially usable surface area of a common disposable surgical mask is not effectively available to the wearer. Any areas of the mask that are pressed flat to the face cannot breathe and therefore cannot filter any air. Accordingly, there is a need for a novel protective mask that eliminates the drawbacks of traditional face masks.
Particularly in a world coping with a devastating pandemic, such as COVID-19, there is a need for inexpensive, well-fitted, leak-resistant and highly breathable protective masks. An improved protective mask offers great value to the medical community and the public-at-large and allows for a safer environment in numerous common and everyday activities, such as travel, work, education, transportation, sports, shopping, and meetings, or anywhere individuals are required to come into close physical contact with others. SARS-CoV-2, the virus responsible for the COVID-19 pandemic, is a virus with remarkable resilience, propagation and multiplication characteristics which require complex technological systems, manner, and mannerisms to assure reasonable protections from and eradication of this virus. Simple multi-use and common disposable single use surgical face masks are well known as a protective measure taken by many individuals to protect themselves and others from exposure to airborne virus particles, allergens, and foreign matter which might otherwise be inhaled or may have otherwise made physical contact with the user's facial area, such as splatter. Also, individuals use these masks to help protect others from pathogens they may otherwise unknowingly expel.
The current generation of masks are often not particularly comfortable and do not form a proper seal.
Various masks have been developed over the years in response to concerns arising out of past epidemics such as Influenza and outbreaks of other infectious diseases such as avian influenza and corona virus variants. These previously known masks are disadvantageous to the extent they cannot achieve a high capture efficiency for pathogens, dust or other particles in the air, while also allowing for high air permeability for ease of breathing for the wearer. Moreover, the seal on common cloth or surgical face masks often do not seal well around the nose, cheeks or bearded areas of the face. Prior art masks that include an upper sealing mechanism do nothing to enhance breathability and do not offer a complete seal around the entire perimeter of the mask. The prior art common pleated surgical mask does not seal well on the cheek area, thereby allowing unfiltered air to pass through the air channels created by the inherent pleats folded into the filter element fabric. Moreover, the known masks that provide some measure of a seal are often required to fit very tightly to the user's face, resulting in discomfort for the wearer, while still potentially not achieving an effective seal. A surgical mask, by design, does not filter or block very small particles in the air that may be transmitted by coughs, sneezes, or certain aerosol-generating medical procedures. Surgical masks also do not provide complete protection from germs and other contaminants because of the often-loose fit between the surface of the face mask and the face. Collection efficiency of surgical mask filters can range from less than 10% to nearly 90% for different manufacturers' masks when measured using the test parameters for NIOSH certification. However, a study found that even for surgical masks with “good” filters, 80-100% of subjects failed an OSHA-accepted qualitative fit test and a quantitative test showed 12-25% leakage. Also, when prior art masks are pulled very tightly to the wearer's face in furtherance of achieving an improved seal, valuable surface area of the mask is rendered inaccessible or useless for the filtering and handling of air.
Prior art masks are also relatively inefficient as far as their capability for functioning as a filtering element. In particular, conventional masks generally do not provide an effective seal, thus limiting their filtering ability, and are also limited in terms of usable surface area thus decreasing their breathability rating. There is a need for a mask that provides much higher filtration ability with the benefit of increased breathability.
Prior art masks that employ multiple filtration layers or masks also suffer from the problem of fluid transfer between the filtration layers that are in physical contact with one another during use.
A need exists for a protective mask effective for filtering airborne pathogens and contaminants, including COVID-19 and other airborne communicable diseases, while providing an adequate seal for optimal safety and filtration efficiency and comfort.
Assuming there comes a time the COVID-19 pandemic passes, a need will still exist for improved, inexpensive and easily manufactured protective masks. Future communicable disease outbreaks and other types of catastrophes and unavoidable environmental hazards will continue to occur.

SUMMARY OF THE INVENTION

In view of the above, it is an object of the present invention to overcome the shortfalls in the related art by presenting an improved protective face mask.
An objective of the present invention is also to provide a protective multi-layer mask with at least two layers of independent filter material
Another objective of the present invention is to provide a protective mask that creates a sufficient seal around the entirety of the mask to the wearer's face without the need of the mask being tightly fitted to the wearer's face.
A further objective of the present invention is to provide a protective mask that offers a high level of comfort and breathability for all shapes of faces.
Yet another object of the present invention is to provide a protective mask that maximizes the total usable surface area of a protective mask. The foam frame helps provide an effective seal of the mask material to the skin around the entire perimeter of the mask, while allowing air to pass through the entire surface area of the mask body, therefore utilizing the entire surface area of the mask filter material, including the mask edges, for air filtration. The foam frame holds the outer mask away from the users face. The foam frame also allows for a looser fit, thereby allowing better breathability of the inner mask filter.
Another objective of the present invention is to provide a protective mask that reduces the liquid transfer from the outer mask layer and inner mask layer, and vice-versa, of a multi-layer protective mask.
The protective mask according to the present invention comprises an inner mask layer, an outer mask layer, and a soft foam frame sandwiched between the inner and outer mask layers. The entire outer edge is fused or adhered together, thereby creating an airtight seal around the entire perimeter of the mask. The foam frame of the protective mask creates a snug, yet comfortable grip to the wearer's face, molds to the shape of the user's face and does not allow the mask to slide down from the wearer's nose or mouth. The mask creates an adequate, leak-proof seal, while not requiring tight, uncomfortable contact with the wearer's nose, mouth or face. This also lessens the need for uncomfortable, tight ear loops to adequately seal the mask to the face.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a side view of an embodiment of the present invention disposed on the face of a wearer.

FIG. 2 is an exploded view of an embodiment of the present invention.

FIG. 3 a is a front view of an outer mask layer of an embodiment of the present invention.

FIG. 3 b is a front view of a foam frame of an embodiment of the present invention.

FIG. 3 c is a rear view of a foam frame of an embodiment of the present invention.

FIG. 3 d is a front view of an inner mask layer of an embodiment of the present invention.

FIG. 4 a is an exploded view of an embodiment of the present invention.

FIG. 4 c is an illustration that shows a foam frame inside an inner and outer mask layer of an embodiment of the present invention.

FIG. 5 is a perspective view of an embodiment of the present invention and a profile cut away view illustrating how the edges of the inner and outer mask layers are heat sealed together.

FIG. 6 is a perspective view of an embodiment of the present invention and a profile cut away view illustrating how the edges of the inner and outer mask layers are heat sealed together.

FIG. 7 a is a front view of a foam frame of an embodiment of the present invention.

FIG. 7 b is a rear view of a foam frame of an embodiment of the present invention.

FIG. 8 is an exploded view of an embodiment of the present invention.

FIG. 9 is an exploded view of an embodiment of the present invention.

FIG. 10 is an exploded view of an embodiment of the present invention.

FIG. 11 is a single element protective mask of an embodiment of the present invention.

FIG. 12 is a foam frame of an embodiment of the present invention.

FIG. 13 is an illustration showing a foam frame and vapor barrier of an embodiment of the present invention.

FIG. 14 is an exploded view of an embodiment of the present invention.

FIG. 15 is a perspective view of an embodiment of the present invention.

FIG. 16 is an exploded view of an embodiment of the present invention.

DETAILED DESCRIPTION

The following detailed description is merely exemplary in nature and is not intended to and should not be interpreted to limit the embodiments described herein. Although particular embodiments are described, those embodiments are merely exemplary implementations of the system of the present invention. The following descriptions and illustrations herein should be considered illustrative in nature, and thus, not in any way limiting the scope of the present invention. One skilled in the art will recognize other embodiments are possible and all such embodiments are intended to fall within the scope of the present disclosure. While the preferred embodiments are described with reference to the above drawings, there is no intent to limit the disclosure to the embodiments shown in the drawings or disclosed herein. Rather, the intent is to include all alternatives, modifications and equivalents that embody the spirit and scope of the disclosure.
It is also to be understood that the disclosure uses terminology for the purpose of describing particular embodiments and such terminology is not intended to be limiting.
Unless defined otherwise, all technical and scientific terms used in this disclosure have the same meaning as commonly understood by one of ordinary skill in the art to which is applicable to this disclosure.
As will be apparent to those of skill in the art upon reading this disclosure, each of the embodiments described and illustrated herein has discrete components and features which may be readily separated or combined with features of any of the other possible embodiments without departing from the spirit and scope of the present disclosure.
FIG. 1 depicts a side view of one embodiment of the present invention disposed on the face of a user. FIG. 2 shows an exploded view of an embodiment of the present invention. As shown in FIG. 2 , this embodiment provides a protective mask 1, which comprises an outer mask layer 2, a foam frame 3, an inner mask layer 4 and a vapor barrier 5. In one embodiment, the outer mask layer 2 and the inner mask layer 4 are constructed from a nonwoven heat-blown filtration medium, such as but not limited to, polypropylene, which is preferred due to its relative softness, flexibility, low density and ability to capture particulates. This is the same material most commonly used in the production of the common disposable surgical mask.
The design of the surgical mask filter depends on the mode; usually, common disposable surgical masks are three-ply (three layers), while in other cases four layers have been an option. This three-ply or four-ply material is made up of a melt-blown polymer, most commonly polypropylene, placed between non-woven fabrics. The melt-blown material acts as the filter that stops microbes from entering or exiting the mask. Filter material in the middle layer or layers may be made of microfibers with an electrostatic charge; that is, the fibers are electrets. An electret filter increases the chances that smaller particles will veer and hit a fiber, rather than going straight through (electrostatic capture) This microfiber typically has resistance to airflow therefore it is imperative to increase the usable surface area of the mask to utilize multiple layers of electrostatically charged microfibers that can create a much higher filtering ability for the common disposable surgical mask. Performance of surgical masks is evaluated based on such parameters as filtration (mask capture of exhaled aerosols), exposure (transfer of aerosols from outside), mask airflow resistance (pressure difference during breathing, ΔP, also known as breathability), liquid penetration resistance, air and water vapor permeability, water repellency (for outer and inner surfaces). All these parameters are dependent upon a proper seal between the mask and the user.
As shown in FIG. 1 , the inner and outer mask layers 2, 4 are adapted to cover the nose and mouth areas of the wearer and the protective mask 1 is designed to fit all sizes and shapes of wearer faces. Further, the two mask layers 2, 4 are physically separated filter elements, providing two layers of filtration material.
The inner mask layer 4 serves a number of advantageous functions. The inner mask layer 4 acts as a filter element to filter air. Further, the inner mask layer 4, by virtue of pressure applied by the securely strapped outer mask layer 2 and foam frame 3, contacts the wearer's face to create a leak-proof seal. The inner mask layer 4 also collects wet or liquid contaminants from the wearer and locks them in, thus preventing these contaminants from being absorbed into the outer mask layer 2 and resulting in a safer protective mask 1. The inner mask layer 4 is comprised of the same hypoallergenic material that is most commonly used in production of the common disposable surgical face mask, and serves as a buffer to prevent the foam frame 3 from directly contacting the wearer's face and causing skin irritation or an allergic reaction. The inner mask layer 4 also acts as a wick to help remove accumulated perspiration in the area where the protective mask 1 seals to the wearer's face, permitting perspiration to evaporate by means of air traveling through the foam frame 3 and filter membranes. The inner mask layer 4 may also filter air through the exposed material on the perimeter of the mask 1 thus increasing usable surface area.
The outer mask layer 2 likewise performs several functions. The outer mask layer 2 filters air and prevents the user and others from inhaling or from being exposed to potentially harmful airborne, liquid and solid pathogens and contaminants. The embodiment shown in FIGS. 1 and 2 shows two elastic ear straps 6, 7 configured to loop around the wearer's ears to secure the outer mask layer 2 to the wearer's face. Any suitable straps commonly used in the face mask industry may be utilized, such as elastic cord, string or individual laces designed to be tied behind the user's head. With the outer mask layer 2 thusly secured to the wearer's face, the outer mask layer 2 applies pressure to the foam frame 3 and that pressure is transferred to the inner mask layer 4 causing the inner mask layer 4 to conform to the face of the wearer, creating a leak-proof seal. The outer mask layer 2 also helps capture and isolate contaminants from the external environment.
The embodiment shown in FIG. 1 further includes a foam frame 3 disposed between the inner and outer mask layers 4, 2. The foam frame 3 is sandwiched between the inner and outer mask layers 4, 2 and may be adhered to the inner and outer mask layers 4, 2 by glue or any other suitable adhesive agent. Alternatively, the foam frame 3 may have an adhesive front and back surface, thus adhering the foam frame 3 to the inner and outer mask layers 4, 2, respectively. The foam frame 3 is preferably comprised of soft foam, such as but not limited to, polyethylene foam. As explained above, the foam frame 3 transfers pressure from the outer mask layer 2 to the inner mask layer 4, thus forcing the inner mask layer 4 to conform to the contours of the wearer's facial structure, thereby creating an effective air seal. The evenly distributed force applied to the inner mask layer 4 by the compressed foam frame 3 also prevents the protective mask 1 from sliding down from the wearer's nose or up from the wearer's chin when facial movements occur while the protective mask 1 is in use. The foam frame 3 is adapted to equally distribute force from the surface of the foam frame 3 that presses the inner mask layer 4 evenly to the wearer's face, thus eliminating pressure points on the wearer's face while creating an adequate seal. The flexible nature of the foam frame 3 allows for low-resistance flexing of the protective mask 1 to comply with the wearer's facial movements, thereby providing a continuous adequate seal across the entirety of the contact area of the protective mask 1 and the wearer's face. Although there is no particular limitation with respect to the specific size of the protective mask 1 of the present invention, it may be advantageous to increase the height:width ratio of the mask because the foam frame 3 holds the outer mask layer 2 farther from the face under the chin as compared to a protective mask used without a foam frame 3. Therefore, increasing the height equally to the thickness of the foam or even more may increase the functionality of the mask 1 by allowing full opening of the mouth and jaw without restriction or unnecessary stretching of the mask 1. Additionally, by increasing the height of the mask, increased usable filtration material surface area is created. Accordingly, the breathability and filtration efficiency potential is increased by creating the ability to use higher grade filter material than has been used in prior art.
As can be seen in FIG. 2 , the foam frame 3 creates a void 8 between the inner and outer mask layers 4, 2, to contain the air within the confines of the inner and outer mask layers 4, 2. The space created between the respective mask layers is advantageous because it minimizes liquid transfer between the outer mask layer 2 and the inner mask layer 4. This void 8 may be adapted to house additional elements to further filter air or to eliminate odors, such as a charcoal element or antimicrobial agents. Because the foam frame 3 holds the outer mask layer 2 away from the wearer's face, the foam frame 3 increases the functional surface area of the protective mask 1, as air is allowed to pass through the foam frame 3 and the entirety of the outer mask layer 2 and through the inner mask 4 edges which creates more usable filter material surface area. The foam frame 3 may advantageously be comprised of breathable foam, thus increasing the effective working area of the protective mask's 1 filter elements (i.e., the front and back mask layers 2, 4).
As shown in FIG. 3C, the foam frame 3 has a nasal bridge region 9 that is shaped to further conform the foam frame 3 and thus holds in place the inner mask layer 4 to the bridge of the wearer's nose. The outer mask layer 2 preferably includes a bendable or moldable nose wire 10 that corresponds with the nasal bridge region 9 of the foam frame 3 (when the fully assembled protective mask 1 is in use), further ensuring a secure fit to the wearer's face. The moldable nose wire 10 may be comprised of a lightweight flexible metal, such as aluminum, or any other suitable flexible or bendable metal. In prior art masks, the nose wire must be conformed to the exact shape of the wearer's nose structure to create a proper seal. This is very difficult to achieve. With the present invention, the nose bridge wire 10 applies direct force only to the foam frame 3. The foam frame 3 ultimately is what helps achieve the seal. Unlike masks of the prior art, the present invention is unique in its use of the nose wire 10 to achieve a proper seal of the mask 1 to the wearer's face. Moreover, unlike the prior art, the nose bridge wire 10 of the present invention does not need to be bent to the exact form of the nose to become a functional component. It requires only a proximal degree of conformity to the shape of the wearer's nose to be functional.
Referring to FIGS. 2, 12 and 13 , a vapor barrier 5, 25 may be affixed to the upper front and back portion of the foam frame 3, preferably with an adhesive. The vapor barrier 5, 25 prevents the wearer's exhaled air from fogging the wearer's eyeglasses. The vapor barrier 5, 25 is comprised of a flexible polyethylene membrane similar to Saran wrap and with an adhesive characteristic that allows it to be secured to the foam frame 3.
FIG. 5 illustrates another embodiment of the present invention where the inner and outer mask layers 11, 12 and the foam frame 13 are bonded together in three layers, forming a pillow-like structure of the protective mask 14. This particular embodiment is essentially comprised of the same components of the embodiment shown in FIGS. 2 and 3 a-d, the difference being here the inner and outer mask layers 11, 12 and the foam frame 13 are bonded together. The edges of the inner and outer mask layers 11, 12 are preferably bonded together, as shown in FIGS. 5 and 6 . A thermal bonding process may be used to bond together the inner and outer mask layers 11, 12, such as the use of ultra-high frequency vibrations which heat the fabric of the mask layers 11, 12 and bond them together. In the preferred embodiment of the present invention, the foam frame 13 is bonded in between the bonded mask layers 11, 12. The foam frame 13 is bonded to the edge of the protective mask 14 and is therefore pinched along the edges of the mask 14, leaving an inflated roll of foam on the inside perimeter of the protective mask 14. The foam frame 13 is sized slightly smaller than the inner and outer mask layers 11, 12, leaving a perimeter edge preferably approximately ⅛ inch around the perimeter of the mask layers 11, 12 to allow for a bonding area around the perimeter of the mask 14 while only partially melting the foam to the bonded edge area. This is sufficient bonding between the disparate materials of the mask and the foam to secure the foam permanently in position within the mask body.
As shown in FIG. 5 , the seam is sealed with heat and the pillow-like form takes effect by the pinching nature of the newly sealed edges. Due to softness and the open-cell, high-air-permeability characteristics of the preferred foam (i.e., polyethylene), the aforementioned sealing process is particularly suitable for constructing the protective mask 14 of this preferred embodiment. One may still thermally bond polypropylene sponge, which is typically but not always a more dense, less soft and less breathable foam, to any other polypropylene product, like a disposable mask. This method would be easier, requires fewer parts and may be completed very quickly. Suitable soft, pliable, and breathable polypropylene foam exists and may be specifically manufactured for this purpose and, thus, is a preferred foam for this particular embodiment. A polyethylene film may be affixed to the top inner and outer edges of the foam frame 13 to function as a vapor seal to prevent fogging of the wearer's eyeglasses.
In another embodiment of the present invention, shown in FIGS. 4 a, 4 b , 6, 8 and 9, a single element protective mask 21 is employed utilizing a similar filter fabric material as described above. This single element protective mask 21 may be advantageously comprised of multiple filtration layers (i.e., up to eight or more layers, or in other words an 8-ply or more filtration layer) to provide for roughly double the filtration ability of a conventional 4-ply mask. A flat sheet of filter material is cut to the same outer dimensions as the protective mask 21 and a rectangular hole is then made into the rear mask filter fabric sheet 22. The inside perimeter edge of the three-ply or four-ply inner filter material of the rear mask filter fabric sheet 22 is adhered or bonded together, thus ensuring utilization of the inner filter material by means of limiting air that may otherwise have seeped between the multiple elements of the filter panel. The protective mask 21 and the rear mask fabric sheet 22 are adhered to one another at their respective perimeters, thereby creating a single unitary mask assembly 30, as shown in FIG. 15 . A pre-formed, breathable and open cell foam rubber frame 24 (shown in FIG. 14 ) is then inserted through the back side of the unitary mask assembly 30 and into a pocket formed between the protective mask 21 and the rear mask filter fabric sheet 22. This foam frame 24 may advantageously be adhered to the mask assembly 30, for example by use of an adhesive to secure the foam frame 24 to the mask assembly 30. For example, as shown in FIGS. 7 a, 7 b and 16, double-sided tape 28 may be placed upon the rear face of the foam frame 24 in order to adhere the foam frame 24 to the rear mask filter fabric sheet 22 when the foam frame 24 is inserted into the pocket formed between the protective mask 21 and the rear mask filter fabric sheet 22. As shown in FIG. 7 a , the double-sided tape strip may also be placed on the front surface of the foam frame 24, thereby adhering the foam frame to the protective mask 21 as well. The foam frame 24 may be securely fitted within the mask assembly 30 with or without the use of any adhesive to adhere the foam frame 24 to the rear mask fabric sheet 22. The foam frame 24 disperses pressure evenly across the entire perimeter of the inner surface of the mask assembly 30, thus creating an adequate seal.
Yet another embodiment of the present invention provides a protective mask comprising the aforementioned outer mask layer 21 adhered to the foam frame 18. FIGS. 7 a, 7 b , and 12 show the foam frame member 18 of this embodiment, which has a self-adhesive surface on its front face to adhere the foam frame 18 to the outer mask layer 21. FIG. 7 b also shows a corresponding self-adhesive surface of the back face of the foam frame 18 that similarly provides a means to adhere the foam frame 18 to a conventional mask worn directly on the user's face. The self-adhesive characteristic of the foam frame 18 surfaces could be created by use of double-sided sticky tape 19, 20 applied to the foam frame 18, as shown in FIGS. 7 a and 7 b . Any other suitable adhesive may be applied to the foam frame member 18 to adhere the foam frame 18 to the outer mask layer 21 or to a conventional mask worn by the user over his or her mouth and nose. This embodiment allows for the protective mask of the present invention to be used with and worn over a separate, conventional face mask or a cloth face mask worn by the user. The creation of an effective seal between the conventional mask and the wearer's face also has the effect of preventing the unwanted sliding of the mask down past the user's nose or up past the user's chin and offers efficient air filtration.
Having described the preferred embodiment of the present invention, any number of changes, variations and improvements which may be apparent to those skilled in the art are within the scope of the invention claimed and described herein.

Claims

1. A protective mask comprising:

an outer mask layer;

an inner mask layer comprised of a single unitary piece of material that covers a user's mouth and nose;

a foam frame disposed between and adhered to the outer mask layer and the inner mask layer; and

ear straps fixed to opposing ends of the outer mask layer for securing the outer mask layer to a wearer's face.

2. A protective mask according to claim 1, wherein said outer mask layer and inner mask layer are comprised of a flexible material.

3. A protective mask according to claim 1, wherein said outer mask layer and inner mask layer are comprised of polypropylene.

4. A protective mask according to claim 1, wherein said outer mask layer further comprises a moldable nose wire configured for rendering the foam frame in a shape that corresponds with a nasal bridge region of the wearer's face.

5. A protective mask according to claim 1, wherein said foam frame further comprises a nasal bridge region shaped to conform the foam frame to the bridge of the wearer's nose.

6. A protective mask according to claim 1, wherein said protective mask further comprises a vapor barrier affixed to a top portion of the foam frame.

7. (canceled)

8. (canceled)

9. (canceled)

10. (canceled)

11. (canceled)

12. (canceled)

13. (canceled)

14. A protective mask comprising:

an outer mask layer;

an inner mask layer comprised of a single unitary piece of material and having a single cut-out hole corresponding to a user's mouth and nose;

ear straps fixed to opposing ends of the outer mask layer for securing the outer mask layer to a wearer's face,

wherein said inner mask layer, outer mask layer and foam frame are bonded together in three layers, forming a pillow-like structure of the protective mask.

15. A protective mask according to claim 14, wherein said inner mask layer, outer mask layer and foam frame are thermally bonded.

16. A protective mask according to claim 14, wherein a plastic wrap material is affixed to said foam frame to provide a vapor seal.

17. A protective mask according to claim 14, wherein said outer mask layer and inner mask layer are comprised of polypropylene.

18. A protective mask according to claim 14, wherein said outer mask layer further comprises a moldable nose wire configured for rendering the foam frame in a shape that corresponds with a nasal bridge region of the wearer's face.

19. A protective mask according to claim 14, wherein said foam frame further comprises a nasal bridge region shaped to conform the foam frame to the bridge of the wearer's nose.

20. A protective mask comprising:

an outer mask;

an inner filter material sheet having a single cut-out hole corresponding to a user's mouth and nose; and

a foam frame disposed between said outer mask and said inner filter material sheet,

wherein said outer mask and said inner filter material sheet are bound together at their respective perimeters, forming a unitary mask assembly having an internal pocket formed between said outer mask and said inner filter material sheet, which houses said foam frame.

21. (canceled)

22. A protective mask according to claim 20, wherein said foam frame is adhered to said inner filter material sheet.

23. A protective mask according to claim 20, wherein said outer mask and said inner filter material sheet are comprised of multiple filtration layers.

24. A protective mask according to claim 14, wherein said single cut-out hole is substantially rectangular-shaped.

25. A protective mask according to claim 20, wherein said single cut-out hole is substantially rectangular-shaped.