I-Flow, a developer of advanced drug delivery systems, has received the 510(k) clearance from the FDA for its stabilized antimicrobial wound gel.
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The product, as yet unnamed, has been FDA cleared for both over-the-counter and prescription-only marketing and distribution. The new stabilized antimicrobial wound gel contains antimicrobial silver in an amorphous gel.
This new product uses the same silver stabilization chemistry as its highly successful SilvaSorb gel, but is even more potent and durable. It was tested in vitro against a current prescription antimicrobial wound product and was found to be more active with minimal adverse tissue reactions, the company said.
Donald Earhart, chairman and CEO of I-Flow, said: “Our new stabilized silver antimicrobial wound gel is yet another unique and unrivaled product that we are proud to add to our growing portfolio of infection-reducing products.”
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