# K123126: Motex Polyisoprene Powder-Free Surgical Gloves Model # 6412(6432) and # 6512(6532)

- Pathway: 510(k) (Traditional)
- Applicant: Shanghai Motex Healthcare Co., Ltd.
- Decided: Jun 4, 2014 after 608 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 K011721 (2001). 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)
- K093300: Esteem SMT Polyisoprene Powder-Free Surgical Sterile Gloves, Cardinal Health, Inc. (2009) Summary page 1.

## Indications for use
MOTEX Polyisoprene Powder-Free Sterile Surgical Gloves are powder-free surgeon's glove 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/K123126
Methodology: https://510kreport.com/methodology