# K232550: Nitrile Examination Gloves, Dual Color Black-Blue

- Pathway: 510(k) (Traditional)
- Applicant: Shanxi Hongjin Plastic Technology Co., Ltd.
- Decided: Oct 20, 2023 after 58 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: 5 generations back to K062764 (2007). 7 ancestors in all.
No later device cites it as a predicate yet.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K201857: Powder Free Nitrile Examination Glove Black and Dual Color White-Blue, Careplus (M) Sdn Bhd (2021) Summary page 5.

## 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/K232550
Methodology: https://510kreport.com/methodology