American Biotech Labs' ASAP Antibacterial Silver Gel receives FDA 510(k) medical device clearance

NewsGuard 100/100 Score

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."

The product utilizes ABL's innovative SilverSol Technology(R), which has garnered multiple patents in the U.S. and several countries throughout the world, including a broad-use patent that provides the company with exclusive rights to use its silver-based products to combat many of the world's most destructive pathogens. ABL has performed extensive anti-microbial studies against bacteria, yeast, fungus and other pathogens. Information about these studies is available at research section of the ABL Website, www.americanbiotechlabs.com/researchprotected/researchmenu.html.

"The FDA's decision to grant clearance for the ASAP Antibacterial Silver Wound Dressing Gel as a prescription device is an extraordinary validation for our company and its patented processes and uses," said Dr. William Moeller, a Managing Director of American Biotech Labs. "This is a major step forward in our mission of using our products to improve lives by combating many of the world's most deadly pathogens."

This is the second ABL product to obtain FDA clearance; in April the company's ASAP Wound Dressing Gel received clearance as a 510(k) over-the-counter medical device.

Source:

American Biotech Labs, LLC

Comments

The opinions expressed here are the views of the writer and do not necessarily reflect the views and opinions of News Medical.
Post a new comment
Post

While we only use edited and approved content for Azthena answers, it may on occasions provide incorrect responses. Please confirm any data provided with the related suppliers or authors. We do not provide medical advice, if you search for medical information you must always consult a medical professional before acting on any information provided.

Your questions, but not your email details will be shared with OpenAI and retained for 30 days in accordance with their privacy principles.

Please do not ask questions that use sensitive or confidential information.

Read the full Terms & Conditions.

You might also like...
Innovative plasma-activated hydrogel dressings revolutionize chronic wound care