# K050181: Medigloves Sterile Powder-Free Synthetic Polyisoprene Surgical Gloves

- Pathway: 510(k) (Abbreviated)
- Applicant: Medigloves, Ltd.
- Decided: Apr 13, 2005 after 76 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 K990710 (1999). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K011721: Esteem Sterile Polyisoprene Surgical Gloves, Allegiance Healthcare Corp. (2001) Summary page 1.
- K002933: Sterile Sensicare Synthetic Polyisoprene Powder-Free Surgical Gloves, Maxxim Medical (2000) Summary page 1.
- K990710: Barrierplus Synthetic Powder-Free Surgical Gloves, Barriermed Glove Co. (1999) Summary page 1.

## Indications for use
A powder-free surgeon's glove is a disposable device made of synthetic material that may bear a trace amount of glove powder and 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/K050181
Methodology: https://510kreport.com/methodology