# K212009: Disposable Nitrile Gloves

- Pathway: 510(k) (Traditional)
- Applicant: Jiangsu Shenglijie Safety Products Co., Ltd.
- Decided: Sep 15, 2021 after 79 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 K171422 (2018). 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)
- K171422: Disposable Powder Free Nitrile Examination Glove, White/ Blue/ Black/ Pink Color, Ever Global (Vietnam) Enterprise Corp (2018) Summary page 5.

## Indications for use
The Disposable nitrile gloves are disposable devices intended for medical purposes that are worn on the examiner’s hands to prevent contamination between patient and examiner.

Source page: https://510kreport.com/device/K212009
Methodology: https://510kreport.com/methodology