TAICHUNG, TAIWAN (April 24, 2014) -- Bio-medical Carbon Technology Co., Ltd. (BCT), a leading global wound dressing developer and manufacturer, announced today that its KoCarbonAg Antimicrobial Dressing and KoCarbonAg Silver Bandage have received 510(k) clearances from the U.S. Food and Drug Administration (FDA), K140147.
KoCarbonAg Antimicrobial Dressing and KoCarbonAg Silver Bandage, the flagship products of BCT, which impregnated with silver to provide excellent proven antibacterial activities, are approved for indications of partial and full thickness wounds, pressure ulcers, diabetic ulcers, surgical wounds, and acute wounds such as first- and second-degree burns.
This is the first ever 510(k) clearance for BCT which is incorporated for only three and half years in Taiwan since October 2010. The 510(k) clearance of KoCarbonAg Antimicrobial Dressing and KoCarbonAg Silver Bandage have opened the door of the world largest medical devices market, and BCT is expected to introduce these products to the U.S. in mid-August.
U.S. Food and Drug Admistration Class II (K140147)
KoCarbonAg® Antimicrobial Dressing
KoCarbonAg® Silver Bandage
About Bio-medical Carbon Technology
Bio-medical Carbon Technology, BCT, develops and manufactures ionic silver coated activated carbon fiber wound care dressings. Its products with proven effectiveness backed by the laboratory tests and clinical trials can treat a broad range of wound types, both acute and chronic wounds. It is proven that its products provide an easy, gentle, faster wound healing. BCT operates worldwide and is supported by its professionals and ongoing development and research. For more information, please visit www.bm-carbon.com