White Paper: Technical Report: An Evaluation of Safety and Efficacy of the Crosstex® Face Mask Treated with BIOSAFE® Antimicrobial Agent. Click here to request a copy of the Technical Report. Available in: English, Spanish (Euro), Spanish (Central American), Italian, German, French (Euro), French (Canadian), Japanese. Brochure: The Crosstex Medical Face Mask Treated with BIOSAFE® Antimicrobial. Click each link to download a copy. English | Spanish (Euro) | Spanish (Central American) | Italian | German French (Euro) | French (Canadian) | Japanese Material Safety Data Sheet: Antimicrobial Masks Treated with Biosafe

A New Medical Face Mask for Today’s Difficult Biological Challenges.

To meet the growing public health challenges of H1N1 and other Influenza A virus strains, as well as an increasing number of antibiotic resistant microorganisms, Crosstex has developed a new generation of antimicrobial medical face masks… the ONLY medical face masks treated with BIOSAFE antimicrobial.

Currently available in the Ultra Sensitive Medical Face Mask only, this unique medical mask also features:

• PFE = 99.8% @ 0.1 micron.
• White fluid-resistant outer layer.
• White hypoallergenic cellulose inner layer.
• Materials FREE of chemicals, inks, dyes and latex.
• Extra softness - Will NOT lint, tear or shred.

BIOSAFE — A Unique Protective Solution.
BIOSAFE is a water-based EPA-registered antimicrobial solution. When applied to Crosstex medical face masks, this antimicrobial treatment provides a long lasting virucidal and bactericidal protective coating that is permanently bound to the medical mask. The safety of BIOSAFE antimicrobial treated medical face masks has been demonstrated in independent testing and poses little or no
risk of promoting antibiotic resistance.

Antimicrobial Efficacy.
Efficacy of Crosstex Medical Face Masks Treated with BIOSAFE Antimicrobial

Advanced Filtration and Protection.
Having the correct level of respiratory protection in a wide variety of healthcare settings is an essential part of a total system of infection prevention and control. Medical face masks are intended to be worn by healthcare personnel during procedures to protect both the patient and the healthcare professional from the spread of infection. The function of the medical mask is to filter varying sizes of live microorganisms, trapping them in the filter medium so they do not pass through the mask. However, while trapped, these microorganisms can continue to live on the mask surface, potentially spreading contamination. The BIOSAFE antimicrobial treatment enhances the superior functional capabilities of the Crosstex medical face mask, killing between 98.5% and 99.999% of the trapped viruses and bacteria within 5 minutes of contact with the medical mask. The result is a long-lasting shield that helps to reduce the cross-contamination risk from touching the medical mask itself.

FDA and EPA Submissions.
The Ultra Sensitive Medical Face Mask treated with BIOSAFE antimicrobial is currently available in specific markets outside of the United States. 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.