# K132802: Motex Powdered Nitrile Surgical Gloves

- Pathway: 510(k) (Traditional)
- Applicant: Shanghai Motex Healthcare Co., Ltd.
- Decided: May 21, 2014 after 257 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 K000178 (2000). 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)
- K000178: Nuzone Nitrile Surgical Gloves, Powdered, Green, Terang Nusa Sdn Bhd (2000) Summary page 1.

## Indications for use
The Motex Powdered Nitrile Surgical Gloves are sterile disposable devices made of synthetic rubber intended to be worn by operating room personnel to protect a surgical wound from contamination. The lubricating or dusting powder used in the glove is excluded.

Source page: https://510kreport.com/device/K132802
Methodology: https://510kreport.com/methodology