# K041276: Powder-Free Nitrile Examination Gloves

- Pathway: 510(k) (Traditional)
- Applicant: Shanghai Motex Healthcare Co., Ltd.
- Decided: Aug 20, 2004 after 100 days
- Product code: LZA (Polymer Patient Examination Glove)
- Device class: 1
- Regulation: 21 CFR 880.6250
- 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 K030207 (2003). 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)
- K030207: Nitrile Powder-Free Examination Gloves, Problue, #7235 7 #7735, Shanghai Motex Healthcare Co., Ltd. (2003) Summary page 1.

## Indications for use
This green powder-free nitrile examination glove is a disposable device made of nitrile rubber that may bear trace amount of powder and is intended to be worn on the hand or finger(s) for medical purposes to provide a barrier against potentially infectious materials and other contaminants (21 CFR 880.6250).

Source page: https://510kreport.com/device/K041276
Methodology: https://510kreport.com/methodology