# K161072: Powder Free Grey Vinyl Examination Gloves

- Pathway: 510(k) (Traditional)
- Applicant: Zibo Flourish Trading Co., Ltd.
- Decided: Jul 14, 2016 after 87 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 K091431 (2009). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K150224: Blue Vinyl Gloves Powder Free, Zibo Sanying Trade Co., Ltd. (2015) Summary page 5.

## Indications for use
The Powder Free Grey Vinyl Patient Examination Gloves is a disposable device intended for medical purposes that is worn on the examiner’s hands or finger to prevent contamination between patient and examiner.

Source page: https://510kreport.com/device/K161072
Methodology: https://510kreport.com/methodology