# K220834: Powder Free Nitrile Examination Glove

- Pathway: 510(k) (Traditional)
- Applicant: Daxwell, LLC
- Decided: Jun 29, 2022 after 99 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: 6 generations back to K993247 (1999). 6 ancestors in all.
No later device cites it as a predicate yet.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K212497: Nitrile Examination Glove (Powder free, Blue), Jiangsu Jinlian Medical Technology Co., Ltd. (2021) Summary page 5.

## Indications for use
The Powder Free 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/K220834
Methodology: https://510kreport.com/methodology