DURHAM, N.C. — February 15, 2021 — ASTM Degree 3 surgical masks manufactured by Freudenberg Efficiency Supplies just lately acquired 510(okay) clearance from the US Meals and Drug Administration (FDA). The surgical masks are supposed to be used by healthcare personnel to guard each the affected person and themselves from switch of microorganisms, physique fluids and particulate materials. The face masks are supposed to be used in an infection management practices to cut back the potential publicity to blood and physique fluids.
For the U.S. market, Freudenberg Efficiency Supplies is now offering FDA cleared surgical masks assembly the Degree 3 customary of the American Society of Testing and Supplies (ASTM). The ASTM Degree 3 surgical masks is to be used in situations the place there’s a excessive threat of fluid and spray of aerosol transmission, similar to working procedures. The masks are a single use, disposable gadget offered non-sterile.
Surgical masks by Freudenberg have been examined for efficiency in 5 areas: fluid resistance, differential strain, particulate effectivity, bacterial filtration effectivity and flammability. Upon completion of testing, the surgical masks constantly met ASTM Degree 3 standards in all 5 efficiency take a look at areas. Bacterial and particle filtration effectivity take a look at outcomes have been better than 99 p.c.
“This was an ideal accomplishment for our group,” stated Alice Pittenger, head of gross sales, North America, World Healthcare Division, Freudenberg.” It’s a milestone that helps our dedication to proceed manufacturing native. Assembly the ASTM Degree 3 customary helps us in our purpose to not solely preserve our healthcare employees secure, but in addition guarantee they’ve a gentle, dependable PPE provide so the shortages that occurred in the beginning of the pandemic don’t occur once more.”
The Durham, N.C., website of Freudenberg Efficiency Supplies started masks manufacturing in 2020 in response to the COVID-19 pandemic. Working carefully with native companions, Freudenberg can be aiming to stop future PPE provide shortages by establishing long-term face masks manufacturing for the U.S. market. The location manufactures surgical masks and group masks and is pursuing NIOSH N95 respirator certification.
Posted February 16, 2021
Supply: Freudenberg Efficiency Supplies