# K021065: Pre-Powdered Sterile Surgeon's Gloves (with a 50 Microgram/GM Protein Claim

- Pathway: 510(k) (Traditional)
- Applicant: Primus Gloves Private, Ltd.
- Decided: May 8, 2002 after 36 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.
1 later device descends from it; 1 cites it directly.
0 of 2 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
- K023139: Romed Latex Surgical Gloves, Powdered, Sterile (2003), 0 descendants of its own

## Indications for use
A surgeon’s glove is a device made of natural or synthetic rubber intended to be worn by operating room personnel to protect a surgical wound from contamination

Source page: https://510kreport.com/device/K021065
Methodology: https://510kreport.com/methodology