# K052031: Powdered Latex Surgeon's Glove

- Pathway: 510(k) (Traditional)
- Applicant: Shun Thai Rubber Gloves Industry Public Co., Ltd.
- Decided: Sep 12, 2005 after 47 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. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
The powdered latex surgeon's glove with protein content labeling claim (200 micrograres or less per gram) is a device made of natural or synthetic rubber intended to be worn by operating room personnel to protect a surgical wound from contamination between patient and operating room personnel.

Source page: https://510kreport.com/device/K052031
Methodology: https://510kreport.com/methodology