# K190095: Powder-Free Clear Vinyl Patient Examination Gloves

- Pathway: 510(k) (Traditional)
- Applicant: Anhui Intco Medical Products Co., Ltd.
- Decided: Jun 20, 2019 after 149 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: 1 generation back to K022091 (2002). 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)
- K022091: Baldur Brand Vinyl Powder-Free Examination Gloves, Tangshan Zhonghong Pulin Group Co., Ltd. (2002) Summary page 5.

## Indications for use
A patient examination glove is a disposable device intended for medical purposes that is worn upon the examiners' hands or fingers to prevent contamination between patients and examiners

Source page: https://510kreport.com/device/K190095
Methodology: https://510kreport.com/methodology