# K190942: Disposable Powder Free Nitrile Examination Glove, Pink/Black Color

- Pathway: 510(k) (Abbreviated)
- Applicant: Ever Growth (Vietnam) Co., Ltd.
- Decided: Jan 7, 2020 after 272 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: 2 generations back to K143247 (2015). 2 ancestors in all.
10 later devices descend from it; 9 cite it directly.
0 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K172642: Orange Non Sterile Powder Free Nitrile Examination Gloves, Central Medicare Sdn Bhd (2017) Summary page 5.

## Most influential descendants
- K210463: Thermoplastic Elastomer (TPE) Hybrid Examination Glove (2022), 1 descendant of its own
- K233740: Black Nitrile Powder Free Patient Examination Glove, Non Sterile (2024), 0 descendants of its own
- K222103: Nitrile Patient Examination Gloves, Powder Free, Pink Color (2023), 0 descendants of its own
- K222531: Synthetic Polymer Glove - Polyethylene (Black) (2023), 0 descendants of its own
- K222715: Black Nitrile Powder Free Patient Examination Glove, Non Sterile (2022), 0 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. 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/K190942
Methodology: https://510kreport.com/methodology