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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You can’t mask quality
We are a small business based in the United States. Our products are designed with the safety of our customers in mind, have undergone rigorous testing, meet the high standards set by the U.S. government, and are fairly priced. Moreover, our products are 100% U.S. made — down to the very last fiber. As the raw materials and our manufacturers are both based in the United States we are able to provide an end-to-end guarantee of the quality of our products and ensure the soundness of our supply chains.
At AMC, we believe your safety matters.
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.
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 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
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.
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.
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
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.