# K232353: Powder Free Nitrile Examination Gloves (Black)

- Pathway: 510(k) (Special)
- Applicant: Shanxi Hongjin Plastic Technology Co., Ltd.
- Decided: Aug 31, 2023 after 24 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 K183287 (2019). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K230779: Powder Free Nitrile Examination Gloves (Black), Tested for Use with Chemotherapy Drugs and Fentanyl Citrate, Shanxi Hongjin Plastic Technology Co., Ltd. (2023) Summary page 4.

## Indications for use
The glove is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner.

Source page: https://510kreport.com/device/K232353
Methodology: https://510kreport.com/methodology