# K212600: Disposable Medical Nitrile Examination Gloves (Non-sterile)

- Pathway: 510(k) (Traditional)
- Applicant: Suqian Linglian Medical Technology Co., Ltd.
- Decided: Nov 18, 2021 after 93 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.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K203191: LYDUS Nitrile Examination Gloves, Powder Free, Nathan Trading Co., Ltd. (2021) Summary page 4.

## Indications for use
Disposable Medical Nitrile Examination Gloves (Non Sterile) are 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/K212600
Methodology: https://510kreport.com/methodology