# K213739: Nitrile Examination Gloves

- Pathway: 510(k) (Traditional)
- Applicant: Hangzhou Runheng Medical Co., Ltd.
- Decided: Jun 22, 2022 after 205 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: 4 generations back to K022548 (2002). 4 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K211515: Nitrile Examination Gloves, Beijing Reagent Latex Products Co., Ltd. (2021) Summary page 4.

## Most influential descendants
- K230633: APOLLO ADVANTAGE Nitrile Examination Gloves (2023), 0 descendants of its own

## Indications for use
Nitrile Examination Gloves are disposable devices intended for medical purpose that are worn on the examiner's hand to prevent contamination between patient and examiner.

Source page: https://510kreport.com/device/K213739
Methodology: https://510kreport.com/methodology