# K990180: Burnfree (4X4, 8X8, 16X24) Sterile Burn & Wound Dressing

- Pathway: 510(k) (Traditional)
- Applicant: Nortrade Medical, Inc.
- Decided: Aug 13, 1999 after 205 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
1. First aid for burns, scalds, cuts, and abrasions. 2. Relieves Pain. 3. Cools and Soothes. 4. Moistens. 5. Non-Adherent 6. Bacteriostatic

Source page: https://510kreport.com/device/K990180
Methodology: https://510kreport.com/methodology