# K230190: Polyver Silver Alginate Dressing (Prescription and OTC)

- Pathway: 510(k) (Traditional)
- Applicant: Roosin Medical Co., Ltd.
- Decided: Nov 17, 2023 after 297 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: 6 generations back to K914579 (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)
- K041316: Antimicrobial Alginate Dressing, Advanced Medical Solutions, Ltd. (2004) Summary page 4.
- K143335: Roosin Silver Calcium Alginate Dressing (Prescription), Roosin Alginate Dressing with Preservative (OTC), Roosin Medical Devices Co., Ltd. (2015) Summary page 4.

## Indications for use
Prescription Use: “Polyver Silver Alginate Dressing” is indicated for the management of moderate to heavily exuding partial to full thickness wounds, including, postoperative wounds, trauma wounds, leg ulcers, pressure ulcers, diabetic ulcers, graft and donor sites. OTC Use: First aid to help in minor abrasions, minor cuts, minor lacerations, minor scrapes, minor scalds and minor burns

Source page: https://510kreport.com/device/K230190
Methodology: https://510kreport.com/methodology