# K063757: Motex Powder-Free Surgical Gloves and Lightly Powdered Surgical Gloves

- Pathway: 510(k) (Traditional)
- Applicant: Shanghai Motex Healthcare Co., Ltd.
- Decided: Jul 27, 2007 after 220 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 K050071 (2005). 1 ancestor in all.
17 later devices descend from it; 3 cite it directly.
0 of 19 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K050071: Medispo (Powdered) and Medispo-PF (Powder-Free) Surgeons Glove, H.B.M. USA Co.,Inc. (2005)

## Most influential descendants
- K130301: Latex Surgeon's Gloves (Powdered and Powder Free) (2013), 14 descendants of its own
- K151114: Medismart ( Latex Surgeon¿s Gloves powdered ) and  Medismart + (Latex Surgeon¿s Gloves Powder Free, Polymer coated with protein (2015), 12 descendants of its own
- K172942: Pristeen (Latex Surgeon’s Gloves Powder Free, Polymer coated with protein content labeling claim of 50 ug/dm2 or less per glove of extractable protein (2018), 11 descendants of its own
- K192328: JR.MEDIK Latex Surgeon’s Gloves Powder Free (2020), 8 descendants of its own
- K212848: Sterile Latex Surgical Gloves Powder Free (2021), 2 descendants of its own

## Indications for use
Motex Powder-Free Surgical Gloves are sterile disposable devices made of natural rubber latex (that may bear a trace amount of glove powder) and is intended to be worn on the hands, usually in surgical settings, to provide a barrier against potentially infectious materials and other contaminants. Motex Powdered Latex Surgical Gloves are sterile disposable devices made of natural rubber latex that bears powder to facilitate donning, and it is intended to be worn on the hands, usually in surgical settings, to provide a barrier against potentially infectious materials and other contaminants.

Source page: https://510kreport.com/device/K063757
Methodology: https://510kreport.com/methodology