# K053102: Biogel Skinsense Powder-Free Non-Latex Surgeon's Glove

- Pathway: 510(k) (Traditional)
- Applicant: Regent Medical Americas, LLC
- Decided: Mar 10, 2006 after 126 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.
2 later devices descend from it; 1 cites it directly.
0 of 3 devices 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.

## Most influential descendants
- K140477: Biogel PS Surgical Glove Series, Biogel Skinsense Surgical Glove Series (2015), 1 descendant of its own
- K193573: Biogel Skinsense Indicator Underglove, Biogel PI Ultratouch, Biogel PI Indicator Underglove, Biogel PI, Biogel PI Micro (2020), 0 descendants of its own

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

Source page: https://510kreport.com/device/K053102
Methodology: https://510kreport.com/methodology