# K053442: Biogel Skinsense Poly-Isoprene Powder-Free Non-Latex Glove

- Pathway: 510(k) (Traditional)
- Applicant: Regent Medical Americas, LLC
- Decided: Mar 7, 2006 after 88 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
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
A powder-free sterile surgeon's glove is a disposable device made of Poly-Isoprene that is intended to be worn on the hands, usually in surgical settings, to provide a barrier against potentially infections materials and other contaminants.

Source page: https://510kreport.com/device/K053442
Methodology: https://510kreport.com/methodology