# K050184: Biogel Skinsense Poly-Isoprene Powder-Free Non-Latex Glove

- Pathway: 510(k) (Traditional)
- Applicant: Regent Medical Americas, LLC
- Decided: Mar 16, 2005 after 48 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.
8 later devices descend from it; 5 cite it directly.
0 of 9 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
- K190077: Biogel® PI UltraTouch S Surgical Glove, Biogel® Pl Ultra Touch S Indicator Underglove (2019), 2 descendants of its own
- K140477: Biogel PS Surgical Glove Series, Biogel Skinsense Surgical Glove Series (2015), 1 descendant of its own
- K213289: Gammex® PI Plus Glove-in-Glove™ System Tested For Use with Chemotherapy Drugs (2023), 0 descendants 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
- K191869: Biogel (R) PI UltraTouch S Surgical Glove with a Low Dermatitis Potential Claim, Biogel (R) PI UltraTouch S Indicator Underglove with a Low Dermatitis Potential Claim (2020), 0 descendants of its own

## Indications for use
A powder-free sterile surgeon's glove is a disposable device made of Poly-Isop)rene 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/K050184
Methodology: https://510kreport.com/methodology