Filligent BioMask gains CE certification
Filligent, a Hong Kong-based biotech company, has achieved CE certification for its BioMask medical facemask.
The BioMask is the first in a series of new products in Filligent's BioFriend anti-microbial personal care range to be launched this year. By complying with the EC's Medical Devices Directive 93/42/EEC, Filligent has met EU requirements for design, efficacy and safety of its BioMask.
The BioMask is based on "intelligent filtration" technology and is made from a scientifically designed and tested multilayer material, which has in its internal structure a unique active layer, which has highly targeted anti-microbial properties.
This patented BioFriend textile layer captures pathogens by mimicking the sites on human cells to which they normally attach, and destroys them by disrupting their surfaces and cell walls. Many viruses, including influenza viruses, are known to bind to a terminal sialic acid residue on the surface of the human cell membrane. The binding agent in the BioFriend mimics the binding action of sialic acid on influenza viruses.
Typical facemasks do not kill airborne pathogens; they are based on a passive mechanical filtration design, which means microbes on or inside the mask can stay alive for many hours, greatly increasing the likelihood of cross-contamination. The BioMask has been tested for dermal biocompatibility following internationally recognised standards set out in ISO10933: Biological Evaluation of Medical Devices. Tests were conducted to evaluate cytotoxicity to cells, skin irritation on contact, and skin sensitisation after repeated contact. No cytotoxicity, irritation or incidence of sensitisation was observed.
Filligent expects widespread adoption of the mask by medical institutions and governments during 2009.