# K213604: ELAZ Nitrile Powder Free Examination Glove

- Pathway: 510(k) (Traditional)
- Applicant: Protect Gloves Co., Ltd.
- Decided: Apr 3, 2022 after 139 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)
- K210898: Disposable Nitrile Examination Gloves (Powder Free, Purple-Blue, Blue), Tangshan Lanhai Medical Supplies Co., Ltd. (2021) Summary page 4.

## Indications for use
ELAZ Nitrile Powder Free Examination Glove is disposable device intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner.

Source page: https://510kreport.com/device/K213604
Methodology: https://510kreport.com/methodology