# K111413: Biogel (R) Indicator (R) Underglove

- Pathway: 510(k) (Special)
- Applicant: Molnlycke Health Care Us, LLC
- Decided: Jan 30, 2012 after 255 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: 1 generation back to K081180 (2008). 1 ancestor in all.
4 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)
- K081180: Skinsense Polyisoprene Underglove, Molnlycke Health Care Us, LLC (2008) Summary page 1.

## Most influential descendants
- 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 Biogel® PI Indicator® Underglove is a disposable device made of polyisoprene blue in color to protect against potentially infectious material and other contaminants.

Source page: https://510kreport.com/device/K111413
Methodology: https://510kreport.com/methodology