# K031368: Powdered Latex Surgeon's Gloves

- Pathway: 510(k) (Traditional)
- Applicant: Cephas Medical Private, Ltd.
- Decided: Jun 22, 2004 after 419 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.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Class I Surgeon’s Gloves (Powdered) 79 KGO: named in the summary without a submission number

## Indications for use
A powdered surgeon's glove is a disposable device made of natural rubber latex that bears powder to facilitate donning and it 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/K031368
Methodology: https://510kreport.com/methodology