# K222578: 3M™ Ioban™ CHG Chlorhexidine Gluconate Incise Drape (contains 2% w/w CHG)

- Pathway: 510(k) (Traditional)
- Applicant: 3M Company
- Decided: May 18, 2023 after 266 days
- Product code: KKX (Drape, Surgical, Antimicrobial)
- Device class: 2
- Regulation: 21 CFR 878.4370
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K801550 (1981). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K140250: 3M Steri-Drape CHG Antimicrobial Incise Drape, 3M Healthcare (2014) Summary page 5.

## Indications for use
3M™ Ioban™ CHG Chlorhexidine Gluconate Incise Drape (contains 2% w/w CHG) is indicated for use as an incise drape with continuous antibacterial activity based on in vitro time kill data out to 90 minutes. It is intended for external use only.

Source page: https://510kreport.com/device/K222578
Methodology: https://510kreport.com/methodology