US FDA gives clearance to BioMask surgical face mask
Filligent mask is treated with antimicrobial/antiviral technology
The US Food and Drug Administration (FDA) has approved a new surgical face mask from Medline Industries that is said to inactivate 99.99% of flu viruses.
Mundelein, Illinois-based Medline is the exclusive distributor of the BioMask in the US to hospitals, nursing homes, surgeries, hospitality and retail chains. The company is also the exclusive healthcare distributor of the product in Canada and Europe.
The BioMask has a hydrophilic plastic coating that absorbs aerosol droplets away from the outer surface of the mask. The first and second layers of the mask are treated with copper and zinc ions that inactivate most influenza viruses.
The single-use mask can be worn for more than five hours but should be replaced if damaged or soiled with blood or other bodily fluids. There is also a version with a convex design, which is engineered for maximum fit, comfort and breathability.
Filligent of Hong Kong develops and manufactures the BioFriend BioMask surgical face mask.
In independent laboratory (in vitro) tests, the BioMask inactivated 99.99% of tested influenza viruses after five minutes’ contact with the surface of the face mask against a range of influenza viruses: influenza A subtypes and strains, H1N1, H3N2, H2N2; avian flu subtypes H5N1, H9N2, H5N2; swine flu subtype H1N1; equine flu subtype H3N8; and Influenza B, under tested contact conditions.
“Seven years of research and development have resulted in a surgical face mask that has proven effective at inactivating several tested strains of viruses when they come in contact with the mask,” said Frank Czajka, president of the Proxima Division at Medline.
“By reducing the bio-burden on the face mask itself, Filligent's antimicrobial/antiviral technologies may improve protection in the hospital, workplace and battlefield,” said Melissa Mowbray-d'Arbela, chief executive of Filligent.
No clinical studies have compared the treated masks with untreated versions.
Filligent says the masks are intended to be worn by operating room personnel during surgical procedures, to protect both the surgical patient, and the operating room personnel, from the transfer of micro-organisms, body fluids and particulate material.
If the laboratory tests are representative of conditions in a workplace setting, it is likely the mask material will inactivate viruses in a clinical setting, said Lisa Brosseau, an associate professor at the University of Minnesota School of Public Health in Minneapolis.
Brosseau has not reviewed the research protocol used to test the masks.
