# K190077: Biogel® PI UltraTouch S Surgical Glove, Biogel® Pl Ultra Touch S Indicator Underglove

- Pathway: 510(k) (Traditional)
- Applicant: Molnlycke Health Care Us, LLC
- Decided: May 24, 2019 after 128 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: 2 generations back to K081180 (2008). 3 ancestors in all.
2 later devices descend from it; 2 cite 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)
- K050184: Biogel Skinsense Poly-Isoprene Powder-Free Non-Latex Glove, Regent Medical Americas, LLC (2005) Summary page 4.
- K111413: Biogel (R) Indicator (R) Underglove, Molnlycke Health Care Us, LLC (2012) Summary page 4.

## Most influential descendants
- 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

## Indications for use
The Biogel® PI UltraTouch S Surgical Glove is a disposable device made of polyisoprene, 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. The Biogel® PI UltraTouch S Indicator Underglove is a disposable device made of polyisoprene, blue in color, 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/K190077
Methodology: https://510kreport.com/methodology