K222578 is an FDA 510(k) clearance for the 3M™ Ioban™ CHG Chlorhexidine Gluconate Incise Drape (contains 2% w/w CHG). This device is classified as 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 FDA review panel. Regulated under 21 CFR 878.4370.
| 510(k) Number | K222578 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 25, 2022 |
| Decision Date | May 18, 2023 |
| Days to Decision | 266 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | Summary PDF |
| Product Code | KKX — Drape, Surgical |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 878.4370 |