# K221754: Ag Foam Dressing Non-Adhesive (OTC); Ag Foam Dressing Adhesive (OTC); Silicone Ag Foam Dressing (OTC); Silicone Ag Foam Dressing with Border (OTC)

- Pathway: 510(k) (Special)
- Applicant: Winner Medical Co., Ltd.
- Decided: Jan 17, 2023 after 215 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: 8 generations back to K914579 (1992). 36 ancestors in all.
No later device cites it as a predicate yet.
0 of 37 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K191819: Ag Foam Dressing Non-Adhesive, Ag Foam Dressing Adhesive, Silicone Ag Foam Dressing, Silicone Ag Foam Dressing with Border, Winner Medical Co., Ltd. (2020) Summary page 4.
- K180570: Silverlon Island Wound Dressing, Silverlon Wound Pad Dressing (also known as Silverlon Burn Pad Dressing), Argentum Medical, LLC (2019) Summary page 5.

## Indications for use
The Silicone Ag Foam Dressing (OTC) /Silicone Ag Foam Dressing with Border (OTC)/ Ag Foam Dressing Non-adhesive (OTC) and Ag Foam Dressing Adhesive (OTC) are indicated to cover and protect, absorb wound exudate, and maintain moisture balance of minor cuts, minor abrasions, minor lacerations, and minor burns.

Source page: https://510kreport.com/device/K221754
Methodology: https://510kreport.com/methodology