# K980382: Non-Woven Compress

- Pathway: 510(k) (Traditional)
- Applicant: Convatec, A Division of E.R. Squibb & Sons
- Decided: Mar 9, 1998 after 35 days
- Product code: KMF (Bandage, Liquid)
- Device class: 1
- Regulation: 21 CFR 880.5090
- 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. The FDA summary names its predicate without a number.
- (no number) Mirasorb Sponges: named in the summary without a submission number

## Indications for use
Non-woven Compress is indicated for use in the management of light to moderately exuding acute wounds such as minor burns, superficial cuts, skin tears, lacerations and abrasions and minor irritations of the skin; and light to moderately exuding chronic wounds such as diabetic ulcers, leg ulcers and pressure ulcers.

Source page: https://510kreport.com/device/K980382
Methodology: https://510kreport.com/methodology