# K982260: Markwell Gauze Sponge

- Pathway: 510(k) (Traditional)
- Applicant: Markwell Intl., Inc.
- Decided: Aug 12, 1998 after 47 days
- Product code: LWH (Counter, Sponge, Surgical)
- Device class: 1
- Regulation: 21 CFR 880.2740
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
Markwell Gauze Sponges are nonsterile and for external use. It is supplied in bulk package (100/200pcs per package). To use it, simply apply the gauze pad to the area and change it when wet, or more often if needed. Markwell Gauze Sponges may be repacked and sterilized by domestic manufacturer. If so, users have to follow the manufacturer's instructions to use it.

Source page: https://510kreport.com/device/K982260
Methodology: https://510kreport.com/methodology