# K051082: Medtrade Products Skin Protective Barrier Wipe (Sterile and Preserved)

- Pathway: 510(k) (Traditional)
- Applicant: Medtrade Products, Ltd.
- Decided: Nov 8, 2005 after 195 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
Longest line of descent: 2 generations back to K821271 (1982). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K955103: 3M NO Sting Barrier Film, 3M Medical Products Group (1996) Summary page 1.
- K973228: Sting Skin Prep Wipe (59420600)/Sting Skin Prep Swab (59420700), Smith & Nephew, Inc. (1997) Summary page 1.

## Indications for use
MedTrade Products Skin Protective Barrier Wipe is a liquid intended for use as a film-forming product, that upon application to intact or damaged skin forms a long lasting waterproof barrier, which acts as a protective interface between the skin and bodily wastes, fluids and adhesive products. It is intended as a primary barrier against irritation from body fluids.

Source page: https://510kreport.com/device/K051082
Methodology: https://510kreport.com/methodology