# K101163: Biogel Orthopro Indicator Underglove

- Pathway: 510(k) (Traditional)
- Applicant: Molnlycke Health Care USA
- Decided: Nov 23, 2010 after 211 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: 3 generations back to K033564 (2004). 6 ancestors in all.
No later device cites it as a predicate yet.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K071565: Biogel Indicator Underglove with Non-Pyrogenic Statement, Molnlycke Health Care Us, LLC (2007) Summary page 1.
- K980942: Regent Biogel Indicator Inner Surgical Glove, London International Group, Inc. (1998) Summary page 1.
- K071465: Biogel Orthopaedic Surgical Glove with Non-Pryogenic Statement, Molnlycke Health Care Us, LLC (2007) Summary page 1.

## Indications for use
The Biogel® OrthoPro® Indicator® 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/K101163
Methodology: https://510kreport.com/methodology