# K973228: Sting Skin Prep Wipe (59420600)/Sting Skin Prep Swab (59420700)

- Pathway: 510(k) (Traditional)
- Applicant: Smith & Nephew, Inc.
- Decided: Nov 25, 1997 after 90 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 K821271 (1982). 2 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K821271: Bard Protective Barrier Film, C.R. Bard, Inc. (1982) Summary page 2.
- K920794: BRND Skin Protection Prep Series 33XX, 3M Health Care, Ltd. (1992) Summary page 2.
- (no number) AllKare Protective Barrier Wipe: named in the summary without a submission number

## Most influential descendants
- K051082: Medtrade Products Skin Protective Barrier Wipe (Sterile and Preserved) (2005), 0 descendants of its own

## Indications for use
Smith & Nephew’s “No Sting Skin Prep™” is intended for use as a liquid film-forming product that when applied to intact skin, forms a film for skin attachment sites for drainage tubes, external catheters, surrounding ostomy sites and adhesive dressings. a) “No Sting Skin Prep™” applies a coating that prepares the skin for adhesives and provides a protective interface that may reduce friction during the removal of tape. “No Sting Skin Prep™” is indicated for skin attachment sites for draining tubes, external catheters, surrounding ostomy sites and other adhesive dressings. b) “No Sting Skin Prep™” can be used in sensitive stoma areas as a skin protectant and may reduce irritation from contact with body wastes and stoma fluid. c) “No Sting Skin Prep™” forms a protective film on skin that serves as a skin protectant which may reduce exposure to urine and feces.

Source page: https://510kreport.com/device/K973228
Methodology: https://510kreport.com/methodology