| Crosstex has launched the Crosstex Ultra
Sensitive Medical Face Mask treated with BIOSAFE® antimicrobial in specific markets outside the United
States. The new antimicrobial treated medical mask has been proven effective against H1N1 and other
Influenza A strains as well as microorganisms including MRSA, Staphylococcus aureus, VRE,
Enterococcus faecalis, Pseudomonas aeruginosa and Salmonella enterica.
Within the United States, the sale of face masks 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
Crosstex 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. BIOSAFE antimicrobial
has passed all U.S. Environmental Protection Agency-required toxicity tests and has an approved EPA
label. EPA approval covering the sale of the treated mask in the U.S.A. for non-medical applications is
pending.
“We developed latex-free Ultra Sensitive Medical Face Masks treated with BIOSAFE antimicrobial to address the
healthcare industry’s greatest infection control challenges – the current H1N1 pandemic and the growing
prevalence of other harmful microorganisms,” states Andrew Whitehead, Vice President of Sales and
Marketing at Crosstex. “As one of the largest U.S. manufacturers of face masks, we are proud to take a
leading role in adapting advanced infection control technologies to meet the changing needs of today’s
health care professionals and their patients.”
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