# K042955: Cuticover Skin Barrier Device

- Pathway: 510(k) (Traditional)
- Applicant: D & D Holdings, LLC
- Decided: Jun 19, 2006 after 601 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 K955103 (1996). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K980117: Nuvo Barrier Film, Biomedical Development Co. (1998) Summary page 1.

## Indications for use
Skin barrier for protection against the detrimental effects of moisture, urine or feces

Source page: https://510kreport.com/device/K042955
Methodology: https://510kreport.com/methodology