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 in the United States.
Face shields: Our face shields are made of plastic and protect the user’s eyes and face from bodily fluids and germs. Face shields intended for medical purposes are regulated by the FDA under 21 CFR 878.4040—surgical apparel.
On April 9, 2020, the FDA issued an Emergency Use Authorization (EUA) in response to a shortage of face shields for use by health care workers as personal protective equipment (PPE) during the COVID-19 pandemic. 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—can help guarantee our customers’ peace of mind.
Surgical Masks: Our 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. Surgical masks do not provide complete protection from germs as a result of their loose fit.
AMC’s Surgical Masks have been tested to the ASTM Level 1 standard by Intertek undergoing rigorous testing that covered filtration efficiency, fluid resistance, and breathability. ASTM chemical testing methods are industry accepted standards for ensuring quality control and reliability of a product. Similar to the Face Shield, our Surgical Mask is also covered under the FDA’s EUA and our facilities are registered with the FDA.
Half Mask Respirators: These masks are designed to form a seal around the nose and mouth, which makes them highly effective at keeping out airborne particles and germs. These masks 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.
To this end, AMC’s Half Mask Respirator have undergone 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 completed, they will go to NIOSH for certification.