Filligent Limited announces that it has received Food and Drug Administration (FDA) clearance for its range of BioFriend BioMask (Series A) surgical facemasks. Market clearance was granted under a new medical device classification for antimicrobial surgical face masks, created by the FDA to accommodate Filligents innovations in infection control and respiratory protection.
Healthcare workers need protection that works with them, not against them, says Melissa Mowbray-dArbela, CEO of Filligent. These masks are designed for real-life hard work and the reality of todays infection control needs, especially pandemics.
The BioFriend BioMask is designed to reduce microbial loads on the face mask. In independent laboratory tests, the BioFriend BioMask face mask inactivated 99.99 percent of tested pandemic and seasonal strains of influenza A and B viruses at 5 minutes, including swine flu and avian flu.
The recent FDA clearance adds to Filligents other first-of-kind medical devices for the BioFriend BioMask range. These include self-sanitizing, antimicrobial facemasks approved by the TGA in Australia, the MHRA in the UK (on behalf of the European Union) and the HSA in Singapore. Filligent was also the first to achieve the new FFP2:2009 standard for its European range of antimicrobial respirators.
BioFriend BioMask-branded face masks will be distributed through Medline as well as available in major U.S. retail chains nationwide in a co-branding deal with CURAD®.