ASAP(R) Antibacterial Silver Wound Dressing Gel is now cleared as a 510(k) medical device "for use in the management of 1st and 2nd degree burns, stasis...pressure...(and) diabetic ulcers, lacerations, abrasions, skin tears, surgical incision sites, device insertion site wounds, graft sites and donor sites"; new ASAP product "has been shown (in laboratory tests) to inhibit the growth of...(Staph...E. coli...MRSA and VRE as well as...Candida."
American Biotech Labs, LLC (ABL), developer of a new class of products based on the company's patented nano-catalytic SilverSol Technology(R), today announced that the company has obtained clearance by the U.S. Food and Drug Administration (FDA) to market its ASAP Antibacterial Silver Wound Dressing Gel as a prescription 510(k) medical device throughout the United States. Clifton Mining Company is a major shareholder in American Biotech Labs.
The FDA 510(k) medical device clearance enables ABL to market its ASAP Antibacterial Silver Gel "for use in the management of 1st and 2nd degree burns, stasis ulcers, pressure ulcers, diabetic ulcers, lacerations, abrasions, skin tears, surgical incision sites, device insertion site wounds, graft sites and donor sites." In addition, according to the draft package insert, the new product "has in laboratory tests been shown to inhibit the growth of microorganisms such as (Staph...E. coli...MRSA and VRE as well as fungi such as Candida albicans."