3M? Ioban? CHG Chlorhexidine Gluconate Incise Drape (contains 2% w/w CHG)

About This 510(k) Submission

K222578 is an FDA 510(k) clearance for the 3M? Ioban? CHG Chlorhexidine Gluconate Incise Drape (contains 2% w/w CHG), a Drape, Surgical (Class II — Special Controls, product code KKX), submitted by 3M Company (St. Paul, US). The FDA issued a Cleared decision on May 18, 2023, 266 days after receiving the submission on August 25, 2022. This device falls under the General Hospital review panel. Regulated under 21 CFR 878.4370.