# K211319: Purism Non-Sterile Powder Free Nitrile Examination Gloves

- Pathway: 510(k) (Traditional)
- Applicant: Dezhou Purism Medical Technology Co., Ltd.
- Decided: Aug 19, 2021 after 111 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 K171422 (2018). 2 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K210057: Blue Nitrile Exam Glove, Powder Free, Real Star Medical Technology Co., Ltd. (2021) Summary page 4.

## Most influential descendants
- K213688: Nitrile Examination Gloves (Model: ZMG1351) (2022), 0 descendants of its own

## Indications for use
The Purism Non-sterile Powder Free Nitrile Examination Gloves is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner.

Source page: https://510kreport.com/device/K211319
Methodology: https://510kreport.com/methodology