# K181315: Antimicrobial gauze sponge dressing, Antimicrobial super sponge dressing, Antimicrobial non-woven sponge dressing

- Pathway: 510(k) (Traditional)
- Applicant: Winner Medical Co., Ltd.
- Decided: Feb 14, 2019 after 272 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: 2 generations back to K041013 (2004). 3 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K160872: PolyPlex Wound Dressing, Global Health Solutions, LLC (2016) Summary page 5.

## Most influential descendants
- K221755: Antimicrobial gauze sponge dressing; Antimicrobial super sponge dressing; Antimicrobial non-woven sponge dressing (2023), 0 descendants of its own

## Indications for use
It is intended for use as primary or secondary dressings for exuding wounds, surgical incisions, lacerations, abrasions, first and second degree burns, wound packing, donor sites, catheter sites, I.V. sites and central lines. Also may be used for securement of primary dressing. The antimicrobial activity of the PHMB and benzalkonium chloride in dressing helps resist bacterial colonization within the dressing.

Source page: https://510kreport.com/device/K181315
Methodology: https://510kreport.com/methodology