# K113233: Powdered Latex Surgical Gloves Sterile, Sterile with Protein Content Labeling Claim

- Pathway: 510(k) (Traditional)
- Applicant: Shen Wei (Usa), Inc.
- Decided: Mar 29, 2012 after 148 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: 2 generations back to K050071 (2005). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K063757: Motex Powder-Free Surgical Gloves and Lightly Powdered Surgical Gloves, Shanghai Motex Healthcare Co., Ltd. (2007) Summary page 1.

## Indications for use
A powdered 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. A powder-free 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/K113233
Methodology: https://510kreport.com/methodology