# K020308: Regent Biogel Skinsense Sterile Powder-Free, Synthetic Polyisoprene Surgeon's Glove

- Pathway: 510(k) (Traditional)
- Applicant: Ssl America'S, Inc.
- Decided: Apr 3, 2002 after 64 days
- Product code: KGO (Surgeon'S Gloves)
- Device class: 1
- Regulation: 21 CFR 878.4460
- 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 K000421 (2000). 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)
- K000421: Biogel Neotech II Powder-Free Neoprene Surgeon's Glove, Ssl Americas, Inc. (Regent Medical) (2000)

## Indications for use
The Biogel® Skinsense™ Sterile, Powder-Free, Synthetic Polyisoprene Surgical Glove is a disposable device made of synthetic material and is intended for use in hospitals and other health care facilities during invasive or non-invasive procedures for the protection of operating room personnel and patients, from microbial migration and surgical wounds from contamination.

Source page: https://510kreport.com/device/K020308
Methodology: https://510kreport.com/methodology