# K221311: Antibacterial Bandage

- Pathway: 510(k) (Traditional)
- Applicant: Winner Medical Co., Ltd.
- Decided: Jun 21, 2023 after 412 days
- Product code: FRO (Dressing, Wound, Drug)
- Device class: U
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K113583 (2012). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K113583: Curad Antibacterial Bandage, Medline Industries, Inc. (2012) Summary page 4.

## Indications for use
Antibacterial bandage is to be applied topically to the skin for management of minor cuts, minor scrapes and minor burns.

Source page: https://510kreport.com/device/K221311
Methodology: https://510kreport.com/methodology