# K171422: Disposable Powder Free Nitrile Examination Glove, White/ Blue/ Black/ Pink Color

- Pathway: 510(k) (Abbreviated)
- Applicant: Ever Global (Vietnam) Enterprise Corp
- Decided: Jun 11, 2018 after 392 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
No predicates in its family tree.
60 later devices descend from it; 45 cite it directly.
0 of 61 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K213121: Disposable Nitrile Examination Glove (2022), 4 descendants of its own
- K232008: Disposable Medical Examination Nitrile Gloves (2023), 3 descendants of its own
- K211914: Nitrile Patient Examination Gloves (2021), 2 descendants of its own
- K210276: Disposable Nitrile Gloves (2021), 2 descendants of its own
- K210057: Blue Nitrile Exam Glove, Powder Free (2021), 2 descendants of its own

## Indications for use
The Nitrile Powder Free patient examination glove 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/K171422
Methodology: https://510kreport.com/methodology