# K980516: Regent Biogel Orthopedic Surgical Glove

- Pathway: 510(k) (Traditional)
- Applicant: London International Group, Inc.
- Decided: Apr 23, 1998 after 72 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
No predicates in its family tree.
3 later devices descend from it; 1 cites it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K071465: Biogel Orthopaedic Surgical Glove with Non-Pryogenic Statement (2007), 2 descendants of its own
- 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
A Sterile surgeon’s Glove is worn on the hand of a Surgeon or similar health care person, to prevent contamination between health care providers and the patient during invasive surgical or similar procedures.

Source page: https://510kreport.com/device/K980516
Methodology: https://510kreport.com/methodology