# K121925: Powdered Latex Surgeon's Glove

- Pathway: 510(k) (Abbreviated)
- Applicant: Suzhou Colour-Way Enterprise Development Co., Ltd.
- Decided: Aug 28, 2013 after 422 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 K062797 (2007). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K062797: Powdered Latex Surgical Glove, Beijing Reagent Latex Products Co., Ltd. (2007) Summary page 1.

## Indications for use
This Powdered Latex Surgeon's Glove is a disposable device made of natural rubber intended to be worn by operating room personnel to protect a surgical wound from contamination.

Source page: https://510kreport.com/device/K121925
Methodology: https://510kreport.com/methodology