# K221532: PHMB Wound Dressing

- Pathway: 510(k) (Traditional)
- Applicant: Winner Medical Co., Ltd.
- Decided: Jan 30, 2023 after 249 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: 5 generations back to K914604 (1992). 15 ancestors in all.
No later device cites it as a predicate yet.
0 of 16 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K192463: PHMB Foam Dressing Non-Adhesive, PHMB Foam Dressing Adhesive, Silicone PHMB Foam Dressing, Silicone PHMB Foam Dressing with Border, Winner Medical Co., Ltd. (2020) Summary page 4.
- K121522: Polyfit Absorbing Antimicrobial Dressings (Otc), Polyremedy, Inc. (2012) Summary page 5.

## Indications for use
PHMB Wound Dressings are indicated for use in the management of post-surgical incisions, pressure sores, venous stasis ulcers, diabetic ulcers, donor sites, abrasions, lacerations, first and superficial second degree burns, dermatologic disorders, other wounds inflicted by trauma and, as a secondary dressing or cover dressing for packed wounds. For Over-the-Counter Use, PHMB Wound Dressing is used for minor abrasions, minor lacerations, minor cuts, minor scalds, and minor burns.

Source page: https://510kreport.com/device/K221532
Methodology: https://510kreport.com/methodology