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February 16, 2021
DURHAM, N.C. February 15, 2021 ASTM Level 3 surgical masks manufactured by Freudenberg Performance Materials recently received 510(k) clearance from the US Food and Drug Administration (FDA). The surgical masks are intended for use by healthcare personnel to protect both the patient and themselves from transfer of microorganisms, body fluids and particulate material. The face masks are intended for use in infection control practices to reduce the potential exposure to blood and body fluids.
For the U.S. market, Freudenberg Performance Materials is now providing FDA cleared surgical masks meeting the Level 3 standard of the American Society of Testing and Materials (ASTM). The ASTM Level 3 surgical mask is for use in conditions where there is a high risk of fluid and spray of aerosol transmission, such as operating procedures. The masks are a single use, disposable device provided non-sterile.