# K211914: Nitrile Patient Examination Gloves

- Pathway: 510(k) (Traditional)
- Applicant: Yingxiang Glove Products Co., Ltd.
- Decided: Oct 14, 2021 after 115 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.
2 later devices descend from it; 2 cite it directly.
0 of 4 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.

## Most influential descendants
- K222527: Nitrile Patient Examination Glove (2022), 0 descendants of its own
- K222534: Nitrile Patient Examination Glove (2022), 0 descendants of its own

## Indications for use
The Nitrile Patient Examination 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/K211914
Methodology: https://510kreport.com/methodology