CMB™ is FDA cleared under K060237 for professional use as an antimicrobial barrier for partial and full-thickness wounds. 510 (K) 060237

In order to achieve FDA clearance, a full panel of FDA required biocompatibility tests, appropriate to wound dressings, was performed on the CMB™ with PROSIT™. The tests included hypersensitivity, skin irritation, systemic injection, pyrogenicity, and cytotoxicity.  The CMB™ Antimicrobial Dressing passed all of these tests and was determined to be non-sensitizing, non-irritating, non-pyrogenic, and non-cytotoxic. 

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