# K101943: Synthetic, Powder-Free Nitrile Examination Gloves

- Pathway: 510(k) (Traditional)
- Applicant: Tangshan Jiteng Plastic Products Co., Ltd.
- Decided: Nov 8, 2010 after 119 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: 3 generations back to K022765 (2002). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K090336: Sunmax Enterprise Shanghai CO. Powder Free Blue Nitrile Patient Examination Glove Tested with Chemotherapy Drugs, Sunmax Enterprise Shanghai Co., Ltd. (2009) Summary page 1.
- (no number) Tangshan Zhonghong Pulin Group Co., Ltd. Powder-Free Nitrile Patient Examination Gloves: named in the summary without a submission number

## Indications for use
A patient examination glove is a disposable device intended for medical purposes that is worn upon the examiner's hands or finger to prevent contamination between patient and examiner (21 CFR 880.6250)

Source page: https://510kreport.com/device/K101943
Methodology: https://510kreport.com/methodology