3M Ioban CHG Chlorhexidine Gluconate Incise Drape (contains 2% w/w CHG)
K-Number: K222578 · 2023-05-18
Applicant3M Company
Decision Date2023-05-18
Product CodeKKX
Advisory CommitteeSU
DecisionSubstantially Equivalent
Device Summary
3M Ioban CHG Chlorhexidine Gluconate Incise Drape (contains 2% w/w CHG) is a medical device manufactured by 3M Company. It received FDA 510(k) clearance on 2023-05-18 under approval number K222578. The device is classified under product code KKX. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the 3M Ioban CHG Chlorhexidine Gluconate Incise Drape (contains 2% w/w CHG)?
3M Ioban CHG Chlorhexidine Gluconate Incise Drape (contains 2% w/w CHG) is a medical device that received FDA 510(k) clearance on 2023-05-18. It is manufactured by 3M Company. The 510(k) number is K222578.
When was 3M Ioban CHG Chlorhexidine Gluconate Incise Drape (contains 2% w/w CHG) approved by the FDA?
3M Ioban CHG Chlorhexidine Gluconate Incise Drape (contains 2% w/w CHG) received FDA 510(k) clearance on 2023-05-18, under approval number K222578.
What company makes 3M Ioban CHG Chlorhexidine Gluconate Incise Drape (contains 2% w/w CHG)?
3M Ioban CHG Chlorhexidine Gluconate Incise Drape (contains 2% w/w CHG) is manufactured by 3M Company.
What is the FDA product code for 3M Ioban CHG Chlorhexidine Gluconate Incise Drape (contains 2% w/w CHG)?
The FDA product code for 3M Ioban CHG Chlorhexidine Gluconate Incise Drape (contains 2% w/w CHG) is KKX.
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Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.