# K980861: Dumex Pak-Its Cotton Gauze Packing Impregnated with Hydrogel

- Pathway: 510(k) (Traditional)
- Applicant: Dumex Medical Surgical Products, Ltd.
- Decided: May 20, 1998 after 76 days
- Product code: MGQ (Dressing, Wound And Burn, Hydrogel W/Drug And/Or Biologic)
- Device class: U
- 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
Intended for use on The hydrogel ... exudative wounds. The dressing ... appropriate environment and maintain a moist ... To be following indications: minor cuts, minor burns and ...

Source page: https://510kreport.com/device/K980861
Methodology: https://510kreport.com/methodology