# K230645: BeneHold™ Surgical Incise Drape with CHG antimicrobial II

- Pathway: 510(k) (Traditional)
- Applicant: Avery Dennison Medical, Ltd.
- Decided: Oct 25, 2023 after 231 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
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
The BeneHold™ Surgical Incise Drape with CHG antimicrobial II is indicated for use as an incise drape with continuous antimicrobial activity (in vitro) from 30 minutes through 4 hours of use against the following organisms: S. aureus, S. epidermidis, E. coli, P. aeruginosa, E. aerogenes, and C. albicans. In vitro testing on the subject drape has also shown continuous antimicrobial activity from 30 minutes through 2.5 hours against E. faecalis and F. oxysporum. It is intended for external use only. Correlation between in vitro results and any clinical event has not been tested.

Source page: https://510kreport.com/device/K230645
Methodology: https://510kreport.com/methodology