# K053443: Biogel Eclipse Non-Pyrogenic Latex Powder-Free Sterile Surgeon's Glove

- Pathway: 510(k) (Traditional)
- Applicant: Regent Medical Americas, LLC
- Decided: Feb 1, 2006 after 54 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.
4 later devices descend from it; 2 cite 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)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K071700: Biogel Sensor Surgeon's Glove with Non-Pyrogenic Statement (2007), 1 descendant of its own
- K062847: Biogel Eclipse Indicator Underglove (2006), 1 descendant of its own
- K112089: Biogel Orthopor Brown Surgical Glove (2011), 0 descendants of its own
- K071414: Biogel Eclipse, Latex, Powder Free, Indicator Underglove with Protein Content Labeling Claim (50 Micrograms or Less) (2007), 0 descendants of its own

## Indications for use
A powder-free sterile surgeon's glove is a disposable device made of de-prolenised latex that is intended to be worn on the hands, usually in surgical settings, to provide a barrier against potentially infectious materials and other contaminants.

Source page: https://510kreport.com/device/K053443
Methodology: https://510kreport.com/methodology