# K170735: Powder-Free Clear Vinyl Patient Examination Gloves

- Pathway: 510(k) (Traditional)
- Applicant: Zibo Yue Fan Medical Products Co, Ltd.
- Decided: Jun 27, 2017 after 109 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: 5 generations back to K000071 (2000). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K142703: Powder-free PVC Vinyl Exam Gloves, Hebei Grandeast Plastic Products Co., Ltd. (2015) 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/K170735
Methodology: https://510kreport.com/methodology