# K071565: Biogel Indicator Underglove with Non-Pyrogenic Statement

- Pathway: 510(k) (Traditional)
- Applicant: Molnlycke Health Care Us, LLC
- Decided: Sep 10, 2007 after 95 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 K033564 (2004). 3 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K980942: Regent Biogel Indicator Inner Surgical Glove, London International Group, Inc. (1998) Summary page 1.
- K060030: The Double Glove, Biobarrier, Inc. (2006) Summary page 1.

## Most influential descendants
- K101163: Biogel Orthopro Indicator Underglove (2010), 0 descendants of its own

## Indications for use
The Biogel® IndicatorTM Underglove is a disposable device made of 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/K071565
Methodology: https://510kreport.com/methodology