# K242146: BIOBRANE Temporary Wound Dressing; BIOBRANE Glove

- Pathway: 510(k) (Traditional)
- Applicant: Smith & Nephew Medical Limited
- Decided: Dec 17, 2024 after 147 days
- Product code: KGN (Wound Dressing With Animal-Derived Material(S))
- 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: 1 generation back to K901369 (1990). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K901369: Green Label Biobrane II and Red Label Biobrane II, Sterling Drug, Inc. (1990) Summary page 5.

## Indications for use
BIOBRANE Dressings are indicated for: • Covering clean partial thickness burn wounds • Split thickness donor sites BIOBRANE Glove is indicated for: • Covering clean partial thickness burn wounds of the hand.

Source page: https://510kreport.com/device/K242146
Methodology: https://510kreport.com/methodology