# K222715: Black Nitrile Powder Free Patient Examination Glove, Non Sterile

- Pathway: 510(k) (Traditional)
- Applicant: Safeskin Retailing (Hk) Limited
- Decided: Dec 3, 2022 after 86 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: 3 generations back to K143247 (2015). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K190942: Disposable Powder Free Nitrile Examination Glove, Pink/Black Color, Ever Growth (Vietnam) Co., Ltd. (2020) Summary page 4.

## Indications for use
A nitrile patient examination glove is a disposable device made of nitrile rubber intended for medical purposes that is worn on the examiner’s hand or finger to prevent contamination between patient and examiner

Source page: https://510kreport.com/device/K222715
Methodology: https://510kreport.com/methodology