# K211515: Nitrile Examination Gloves

- Pathway: 510(k) (Abbreviated)
- Applicant: Beijing Reagent Latex Products Co., Ltd.
- Decided: Aug 24, 2021 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: 3 generations back to K022548 (2002). 3 ancestors in all.
2 later devices descend 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)
- K192333: Blue Nitrile Examination Gloves Powder Free, Jr Engineering & Medical Technologies (M) Sdn. Bhd. (2020) Summary page 5.

## Most influential descendants
- K213739: Nitrile Examination Gloves (2022), 1 descendant of its own
- K230633: APOLLO ADVANTAGE Nitrile Examination Gloves (2023), 0 descendants of its own

## Indications for use
Beijing Reagent Latex Products Co., Ltd. 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/K211515
Methodology: https://510kreport.com/methodology