A unique facemask treated with BIOSAFE®, that is effective against H1N1 virus made from BIOSAFE’s novel antimicrobial polymer, has been introduced by Crosstex. Crosstex' new BIOSAFE-treated Ultra Sensitive facemasks begin to reduce microorganisms such as MRSA, VRE, and Staph immediately upon contact, and have further proven to be effective against Influenza A strains such as seasonal flu and the novel H1N1 virus. The facemasks serve as the first line of defense against airborne particles by trapping them in the filter media. However, live microorganisms can continue to live on the mask surface. The new facemasks enhance the functionality of the mask by actually killing the harmful microorganisms, reducing the cross-contamination risk from touching the mask itself, and creating a safer environment upon disposal of the mask. The BIOSAFE treatment additive, is approved by the EPA, and chemically binds to the outer mask surface creating a long-lasting shield against microbial contamination. Because
BIOSAFE mechanically kills cells, it will not cause development of more resistant 'superbugs'. BIOSAFE's HM4100 is better, faster, and less costly as an antimicrobial
additive. It provides protection for the life of the product and because of the way it works it does not promote adaptive organisms or 'superbugs'. Our product's safety is unparalleled and it has passed all required toxicity tests and received an EPA label. It has also passed USP / ISO biocompatibility tests that are normally required for medical device materials.
Within the United States, the sale of facemasks treated with BIOSAFE antimicrobial for medical applications is subject to a 510(k) clearance by the U.S. Food and Drug Administration. At this time the Company is awaiting publication of the latest revision of the FDA Guidance Document pertaining to antimicrobial treatments of medical devices prior to the filing of its application. The Company is in the process of submitting an application with the U.S. Environmental Protection Agency covering the sale of treated masks in the United States for non-medical applications.