The COVID-19 pandemic exposed the shortage of personal protective equipment (PPE) critical to the safety of humanity, but especially that of health care workers who are on the front lines of the response to the global health crisis. The rush to address this shortage has come at a price, figuratively as well as literally. While on one hand the quality of PPE has suffered due to lax monitoring of imports, on the other, some vendors, sensing an opportunity to make a quick buck as a result of the mismatch between demand and supply, sell their products at inflated prices. The pandemic has also disrupted global supply chains, which has affected the reliability of the imports of lifesaving PPE. This is where American Mask Company (AMC) stands out.


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The Process – Vetted & Tested

In the United States, the Food and Drug Administration (FDA) and the National Institute for Occupational Safety and Health (NIOSH) are responsible for evaluating and regulating respiratory protective devices. At AMC, we put our products through a rigorous testing process to meet the highest standards to safely protect you.

NIOSH Logo

The National Institute for Occupational Safety and Health (NIOSH) is part of the U.S. Centers for Disease Control and Prevention in the U.S. Department of Health and Human Services. Ninety-five percent is the minimum level of filtration that will be approved by NIOSH for particulate-filtering facepiece respirators. Devices such as the N95 Half Mask Respirator with Cartridges must receive NIOSH certification and meet standards and test results specified by 42 Code of Federal Regulations (CFR) Part 84 before they can be used by the public.

FDA Logo

The Food and Drug Administration (FDA) is a federal agency in the U.S. Department of Health and Human Services. It is responsible for “protecting the public health by ensuring the safety, efficacy, and security of human and veterinary drugs, biological products, and medical devices.”

ASTM Logo

ASTM International, formerly the American Society for Testing and Materials, is one of the largest voluntary standards developing organizations in the world. ASTM’s chemical testing methods are industry accepted standards for ensuring quality control and reliability of a product.

Products, Standards & Certifications

American Mask Company is registered with the FDA:
FDA Owner & Operator Number 10077733

Face Shield

Face Shields

Our face shields are made of plastic and protect the user’s eyes, nose, and mouth from splashes, sprays, and germs.

Face shields intended for medical purposes are regulated by the FDA under 21 CFR 878.4040—surgical apparel. Face shields are Class I devices and are exempt from premarket notification requirements under 510(k) of the Federal Food, Drug, and Cosmetic Act (FD&C Act).

The fact that our face shields and the facilities in which they are manufactured are registered with the FDA—which makes the products easy to trace in the event of a recall—provides our customers with peace of mind.

Medical Mask

Surgical Mask, ASTM Level 1

Surgical masks are fluid-resistant, disposable, and loose-fitting devices that create a physical barrier between the mouth and nose of the wearer and the immediate environment. They do not provide complete protection from germs as a result of their loose fit.

AMC has passed ASTM Level 1 standards from Intertek, a globally accredited quality assurance provider, for its surgical masks. The product has been put through rigorous testing that covers filtration efficiency, fluid resistance, and breathability. Our product and our manufacturing facilities is currently being registered with the FDA.

AMC meets ASTM Level 1 standards (surgical mask grade) for its surgical mask.
Status: Passed

Respirator

Reusable Half Mask Respirator

The Half Mask Respirator is fitted with air filtration cartridges that can be changed to enable safe reuse of the product.

AMC’s Half Mask Respirator are undergoing rigorous pre-certification testing at the U.S. Army Combat Capabilities Development Command (CCDC) Chemical Biological Center at Aberdeen Proving Ground, Maryland— one of only a handful of agencies that has both the expertise and the equipment necessary to perform tests that precisely measure materials’ filtration efficiencies in strict accordance with NIOSH standards. Once they clear this testing, we will seek NIOSH certification for the masks before making them available for sale to the public.

AMC’s Half Masks are undergoing testing to ensure they meet NIOSH standards.
Status: Pending

FACE SHIELD

Listing No. D418542 | Product Code: LYU (Category: Accessory, Surgical Apparel) Registration/FEI Number: 3002932458.

Face shields are deemed a Class 1 medical device exempt from pre-market notification 510(k)—this is a submission made to the FDA to demonstrate that the device to be marketed is as safe and effective as a legally marketed device [Section 513(i)(1)(A) FD&C Act]. Face shields must meet the following specifications:

  • Must meet ANSI/ISEA Z87.1-2015 standard: “This standard sets forth criteria related to the general requirements, testing, permanent marking, selection, care, and use of protectors to minimize the occurrence and severity or prevention of injuries from such hazards as impact, non-ionizing radiation and liquid splash exposures in occupational and educational environments including, but not limited to, machinery operations, material welding and cutting, chemical handling, and assembly operations,” as per the Centers for Disease Control and Prevention (CDC).
  • Must cover the front and sides of the face, be full face length with outer edges of the face shield reaching at least to the point of the ear, include chin and forehead protectors, and cover the forehead
  • Must include a single Velcro strap and/or elastic strap
  • Must be treated for anti-glare, anti-static, and anti-fogging properties
  • Equivalent or similar to Medline NONFS300

SURGICAL MASK, ASTM LEVEL 1

Listing No.: Pending | Product Code: Pending | Registration/FEI Number: Pending

FDA regulates face masks under 21 CFR 878.4040 as Class I 510(k)-exempt devices. Face masks are authorized under the EUA when they are intended for use as source control, by members of the general public as well as healthcare professionals in healthcare settings, to cover their noses and mouths.

AMERICAN MASK COMPANY

D-U-N-S Number: 117635507 | Provided by Dun & Bradstreet, D-U-N-S Numbers are often referenced by lenders and potential business partners to help determine the reliability and/or financial stability of the company in question.

SAM Registered | U.S. federal government’s “System for Award Management”

CAGE Code: 8PWK3 | The Commercial and Government Entity (CAGE) Code is a five-character ID number assigned by the Department of Defense’s Defense Logistics Agency (DLA) and used extensively within the federal government. The CAGE Code supports a variety of mechanized systems throughout the government and provides a standardized method of identifying a given legal entity at a specific location.

NAICS: The North American Industry Classification System (NAICS) is the standard used by Federal statistical agencies in classifying business establishments for the purpose of collecting, analyzing, and publishing statistical data related to the U.S. business economy:

315990 - Apparel Accessories and Other Apparel Manufacturing

423450 - Medical, Dental, and Hospital Equipment and Supplies Merchant Wholesalers

339113 - Surgical Appliance and Supplies Manufacturing

339115 - Ophthalmic Goods Manufacturing

Government Partner

AMC products meet the criteria to work with federal, state, and local governments to support communities and professionals in all industries. To request more information about our facial PPE system, please fill out the form below.