# K171460: Powder-free Clear Vinyl Patient Examination Gloves

- Pathway: 510(k) (Traditional)
- Applicant: Shandong Zhiwei Medical Products, Co., Ltd.
- Decided: Sep 24, 2017 after 129 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: 3 generations back to K000071 (2000). 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)
- K100699: Powder-Free Vinyl Patient Examination Gloves, Shijiazhuang Star Plastic Co., Ltd. (2010) Summary page 4.
- K022091: Baldur Brand Vinyl Powder-Free Examination Gloves, Tangshan Zhonghong Pulin Group Co., Ltd. (2002) Summary page 4.

## Indications for use
A patient examination glove is a disposable device intended for medical purposes that is worn upon the examiner’s hands or fingers to prevent contamination between patient and examiner.

Source page: https://510kreport.com/device/K171460
Methodology: https://510kreport.com/methodology