# K071700: Biogel Sensor Surgeon's Glove with Non-Pyrogenic Statement

- Pathway: 510(k) (Traditional)
- Applicant: Molnlycke Health Care Us, LLC
- Decided: Sep 11, 2007 after 82 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 K053443 (2006). 1 ancestor in all.
1 later device descends from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K053443: Biogel Eclipse Non-Pyrogenic Latex Powder-Free Sterile Surgeon's Glove, Regent Medical Americas, LLC (2006) Summary page 1.

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

## Indications for use
The Biogel® SensorTM Surgeon's Glove is a sterile 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/K071700
Methodology: https://510kreport.com/methodology