Filligent Makes History - Receives FDA Approval
We are proud to announce that Filligent has received an FDA 510k letter, dated May 26, 2011, which clears the BioFriend™ BioMask™ (Series A) for sale in the United States as a Class II medical device. A new era of infection control has begun.
Our technology is so revolutionary, a brand new medical device classification was created to accommodate our innovations. Called “OUK”, it stands for “anti-microbial / anti-viral surgical facemasks”.
This marks a first for the USA and a first for Filligent. It is also a first for Hong Kong and China – no other Chinese company has received such recognition for a medical innovation. This FDA approval now joins our other first-of-breed, best-of-breed approvals from the TGA in Australia, the MHRA in the UK (and EU) and the HSA in Singapore.
The game-changing properties of the BioFriend™ BioMask™ were recently confirmed by a user study conducted by Henry Schein Incorporated (a global leader in dental supplies), which found that around two-thirds of Australian dentists would (i) replace their existing masks with the BioMask™ , (ii) recommend it to others and (iii) found the price reasonable. This is disruptive news for a healthcare industry plagued with stagnant market share. By reducing the bioburden of ordinary devices without changing human practices (such as touching facemasks), Filligent’s technologies stand to revolutionize infection control.
Our thanks to the Filligent R&D team who shepherded this through FDA approval over the last year and also for developing a long pipeline of even more advanced technologies for personal respiratory protection under the BioMask™ range and new technologies in advanced personal hygiene protection under the SMARTline™.
To read more please click here for our official press release statement.
Save Lives. Stay Strong.