Myflon Surgical Mask LEVEL 3 is now FDA 510K approved. we are honored to be Turkey`s first FDA 510K cleared surgical mask brand. FDA 510K clearance ensures additional safety and higher quality regulation to our products.
ASTM Level 3 surgical masks manufactured by Myflon 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 US market, Myflon is now providing FDA 510K 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 Myflon 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 high performance products. 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,”24 January 2022