# K222534: Nitrile Patient Examination Glove

- Pathway: 510(k) (Traditional)
- Applicant: Jiangxi Jiangxi Zhonghong Pulin Medical Products Co., Ltd.
- Decided: Nov 23, 2022 after 93 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: 2 generations back to K171422 (2018). 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)
- K211914: Nitrile Patient Examination Gloves, Yingxiang Glove Products Co., Ltd. (2021) Summary page 4.

## Indications for use
The Nitrile Patient Examination Glove is a non-sterile disposable device intended for medical purposes that is worn on the examiner's hands or finger to prevent contamination between patient and examiner.

Source page: https://510kreport.com/device/K222534
Methodology: https://510kreport.com/methodology