# K211239: Vinyl Patient Examination Gloves

- Pathway: 510(k) (Traditional)
- Applicant: Jiangxi Shengda Medical Technology Co., Ltd.
- Decided: Jul 17, 2021 after 82 days
- Product code: LYZ (Vinyl 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 K091431 (2009). 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)
- K163168: Vinyl Examination Gloves (White), Vinyl Examination Gloves (Blue), Vinyl Examination Gloves (Yellow), Hebei Hongtai Plastic Products Company Limited (2017) Summary page 4.

## Indications for use
The Vinyl Patient Examination Gloves are disposable devices intended for medical purposes that are worn on the examiner's hands to prevent contamination between patient and examiner.

Source page: https://510kreport.com/device/K211239
Methodology: https://510kreport.com/methodology