DURHAM - Freudenberg Performance Materials has received 510(k) clearance from the US Food and Drug Administration (FDA) for its ASTM Level 3 surgical masks.
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 facemasks are intended for use in infection control practices to reduce the potential exposure to blood and body fluids.
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 with bacterial and particle filtration efficiency test results greater than 99%.
“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,” said 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.