# K160684: Atteris No-Sting Skin Protectant

- Pathway: 510(k) (Traditional)
- Applicant: Rochal Industries, LLC
- Decided: Jul 26, 2016 after 137 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: 1 generation back to K955103 (1996). 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)
- K955103: 3M NO Sting Barrier Film, 3M Medical Products Group (1996) Summary page 6.

## Indications for use
Atteris No Sting Skin Protectant is intended for application to intact or damaged skin as a liquid, film-forming product, which creates a long-lasting waterproof barrier, protecting the skin from 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/K160684
Methodology: https://510kreport.com/methodology