Antimicrobial surgical masks gain FDA clearance

Filligent has received U.S. Food and Drug Administration (FDA) marketing clearance for the BioFriend BioMask for sale in the U.S. as a class II medical device.

The antimicrobial/antiviral surgical face masks incorporate a hydrophilic plastic coating and antimicrobial inner layer that do not restrict airflow and are totally safe, according to the company. The outer white shield is formulated from a combination of commonly used food additives, while the inner blue layer uses ingredients approved by the FDA for biomedical use.

The masks are effective against 18 strains of human, avian, and animal influenza, tuberculosis, methicillin-resistant Staphylococcus aureus (MRSA), and other dangerous diseases, Filligent noted.

A user study conducted by Henry Schein earlier this year found that 63% of Australian dentists would replace their existing masks with the BioMask, 77% would recommend it to others, and 62% found the BioMask "reasonably priced," according to Filligent.