# K071465: Biogel Orthopaedic Surgical Glove with Non-Pryogenic Statement

- Pathway: 510(k) (Traditional)
- Applicant: Molnlycke Health Care Us, LLC
- Decided: Sep 11, 2007 after 105 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.
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)
- K980516: Regent Biogel Orthopedic Surgical Glove, London International Group, Inc. (1998) Summary page 1.
- K060030: The Double Glove, Biobarrier, Inc. (2006) Summary page 1.

## Most influential descendants
- K112089: Biogel Orthopor Brown Surgical Glove (2011), 0 descendants of its own
- K101163: Biogel Orthopro Indicator Underglove (2010), 0 descendants of its own

## Indications for use
The Biogel Orthopedic Surgeon's Glove 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/K071465
Methodology: https://510kreport.com/methodology