FDA Clears First Ever Anti-Viral Surgical Face Mask

July 5, 2011

Filligent limited has received FDA clearance for its range of surgical facemasks – BioFriend™ BioMask™ (Series A).  The market clearance was granted recently under a new medical device classification for anti-microbial surgical facemasks.  The new classification, clinic “OUK,” was created by the FDA “to accommodate Filligent’s innovations in infection control and respiratory protection,” according to the company.

Being awarded the “OUK” medical device classification marks a first for the USA and a first for Filligent. It is also a first for the global healthcare industry, marking a new era in infection control and medical and work-pattern innovations.

“Healthcare workers need protection that works with them, not against them,” says Melissa Mowbray-d’Arbela, CEO of Filligent. “These masks are designed for real-life hard work and the reality of today’s infection control needs, especially pandemics.”

The new mask is an improvement over ordinary facemasks because it reduces the bio-burden of germs on the mask.

Ordinary facemasks contribute to HAIs. Ordinary facemasks create “bio-burdens” – they accumulate germs, even when used properly. We breathe and cough germs onto them, then touch, adjust and discard them – potentially spreading disease as we use them, infecting ourselves and others.

By contrast, the BioFriend™ BioMask™ reduces the bio-burden of germs on the mask. This reduces the wearer’s exposure to germs, and combats key sources for HAIs. When multiplied by the thousands of masks used daily in a hospital, the overall bio-burden of the hospital as a whole can be significantly reduced by the BioFriend™ BioMask™ technology. In this way, affordable anti-microbial technologies like the BioFriend™ BioMask™ surgical facemask can transform infection control in the United States.


Press Release, Filligent’s Biofriend™ Biomask™ Wins Fda Clearance For First Ever Anti-Viral Face Mask.  Business Wire, June 27, 2011.  FDA approval of Filligent’s BioFriend Biomask.

Tinker Ready.  FDA Clears First Antiviral Surgical Mask.  Medscape News, July 5, 2011.

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