Surgical Masks by Freudenberg receive 510(k) clearance from the FDA

For the US 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.

Surgical masks by Freudenberg were tested for performance in five areas: fluid resistance, differential pressure, particulate efficiency, bacterial filtration efficiency and flammability. Upon completion of testing, the surgical masks consistently met ASTM Level 3 criteria in all five performance test areas. Bacterial and particle filtration efficiency test results were greater than 99 percent.

“This was a great accomplishment for our team. It is a milestone that supports our commitment to continue manufacturing local. Meeting the ASTM Level 3 standard helps us in our goal to not only keep our healthcare workers safe, but also ensure they have a steady, reliable PPE supply so the shortages that happened at the beginning of the pandemic don’t happen again,” Alicen Pittenger, Head of Sales – North America – Global Healthcare Division, Freudenberg.

The Durham, NC site of Freudenberg Performance Materials began mask production in 2020 in response to the COVID-19 pandemic. Working closely with local partners, Freudenberg is also aiming to prevent future PPE supply shortages by establishing long-term face mask production for the US market. The site manufactures surgical masks and community masks and is pursuing NIOSH N95 respirator certification.