# K081180: Skinsense Polyisoprene Underglove

- Pathway: 510(k) (Traditional)
- Applicant: Molnlycke Health Care Us, LLC
- Decided: Aug 26, 2008 after 123 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.
5 later devices descend from it; 1 cites it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names no predicate by number.

## Most influential descendants
- K111413: Biogel (R) Indicator (R) Underglove (2012), 4 descendants of its own
- K190077: Biogel® PI UltraTouch S Surgical Glove, Biogel® Pl Ultra Touch S Indicator Underglove (2019), 2 descendants of its own
- K213289: Gammex® PI Plus Glove-in-Glove™ System Tested For Use with Chemotherapy Drugs (2023), 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
- K150146: Biogel PI Micro Indicator Underglove (2015), 0 descendants of its own

## Indications for use
The Skinsense Polyisoprene Underglove is a disposable device made of non-natural rubber latex that is intended to be worn on the hands, usually in a surgical setting, to provide a barrier against potentially infectious material and other contaminants.

Source page: https://510kreport.com/device/K081180
Methodology: https://510kreport.com/methodology