# K042226: Syntex Powder-Free Nitrile Examination Glove, Tested for Chemotherapy

- Pathway: 510(k) (Traditional)
- Applicant: Syntex Healthcare Products Co., Ltd.
- Decided: Sep 30, 2004 after 44 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 K020493 (2002). 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)
- K020493: Syntex Powder-Free Nitrile Examination Glove, Syntex Healthcare Products Co., Ltd. (2002) Summary page 1.

## Indications for use
A patient examination glove is disposable device intended for medical purpose that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.

Source page: https://510kreport.com/device/K042226
Methodology: https://510kreport.com/methodology