# K092712: Skin Barrier Film

- Pathway: 510(k) (Traditional)
- Applicant: Lodestar Products, Inc.
- Decided: Feb 23, 2010 after 173 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. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
Skin Barrier Film is a liquid intended far use as a film-fanning product. Upon application to intact or damaged skin, this product forms a long-lasting watetproof barrier, which acts as a protective interface between the skin and bodily wastes, fluids, adhesive products, and friction. It is intended as a primary barrier against irritation from body fluids.

Source page: https://510kreport.com/device/K092712
Methodology: https://510kreport.com/methodology