# K212311: Medical Examination Gloves

- Pathway: 510(k) (Traditional)
- Applicant: Guangzhou Junda Gloves Co., Ltd.
- Decided: Oct 21, 2021 after 90 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: 1 generation back to K171422 (2018). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K171422: Disposable Powder Free Nitrile Examination Glove, White/ Blue/ Black/ Pink Color, Ever Global (Vietnam) Enterprise Corp (2018) Summary page 4.

## Indications for use
The Medical Examination Gloves are disposable devices intended for medical purposes that are worn on the examiner’s hands or finger to prevent contamination between patient and examiner.

Source page: https://510kreport.com/device/K212311
Methodology: https://510kreport.com/methodology