# K213121: Disposable Nitrile Examination Glove

- Pathway: 510(k) (Traditional)
- Applicant: Jiangsu Cureguard Glove Co., Ltd.
- Decided: Mar 15, 2022 after 169 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.
4 later devices descend from it; 1 cites it directly.
0 of 6 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 4.

## Most influential descendants
- K232008: Disposable Medical Examination Nitrile Gloves (2023), 3 descendants of its own
- K240361: Powder Free Green Nitrile Examination Gloves (XS/S/M/L/XL); Powder Free Pink Nitrile Examination Gloves (XS/S/M/L/XL); Powder Free Purple Nitrile Examination Gloves (XS/S/M/L/XL) (2024), 1 descendant of its own
- K253824: Powder Free Nitrile Examination Gloves Non-Sterile Black (2026), 0 descendants of its own
- K260806: Nitrile Disposable Examination Gloves (2026), 0 descendants of its own

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

Source page: https://510kreport.com/device/K213121
Methodology: https://510kreport.com/methodology