# K220343: Nitrile Examination Gloves

- Pathway: 510(k) (Traditional)
- Applicant: Nb Medical Co., Ltd.
- Decided: Apr 2, 2022 after 54 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.
1 later device descends from it; 1 cites it directly.
0 of 3 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
- K242812: NITRILE EXAMINATION GLOVES (Tested For Use With Chemotherapy Drugs) (2024), 0 descendants of its own

## Indications for use
The NITRILE EXAMINATION GLOVES is a non-sterile disposable device intended for medical purposes that is worn on the examiner's hands or finger to prevent contamination between patient and examiner.

Source page: https://510kreport.com/device/K220343
Methodology: https://510kreport.com/methodology