# K221755: Antimicrobial gauze sponge dressing; Antimicrobial super sponge dressing; Antimicrobial non-woven sponge dressing

- Pathway: 510(k) (Special)
- Applicant: Winner Medical Co., Ltd.
- Decided: Jan 13, 2023 after 211 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: 3 generations back to K895993 (1990). 8 ancestors in all.
No later device cites it as a predicate yet.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K181315: Antimicrobial gauze sponge dressing, Antimicrobial super sponge dressing, Antimicrobial non-woven sponge dressing, Winner Medical Co., Ltd. (2019) Summary page 5.
- K070653: Kendall Kerlix Antimicrobial Super Sponge Dressing for Otc Use, Model 6662, Tyco Healthcare (2007) Summary page 5.

## Indications for use
Antimicrobial gauze sponge dressing, antimicrobial super sponge dressing, and antimicrobial non-woven sponge dressing 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/K221755
Methodology: https://510kreport.com/methodology