# K102976: Powdered Vinyl Patient Examiniation Gloves, Clear (Non-Colored)

- Pathway: 510(k) (Traditional)
- Applicant: Heze Juxinyuan Food Co., Ltd.
- Decided: Dec 13, 2010 after 68 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: 7 generations back to K893822 (1989). 8 ancestors in all.
No later device cites it as a predicate yet.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K091662: Powdered Vinyl Patient Examination Gloves, Zhangjiagang Fengyuan Plastic Products Co., Ltd. (2009) Summary page 2.

## Indications for use
Powdered Vinyl Patient Examination Gloves, Clear (non-colored) is a non-sterile disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.

Source page: https://510kreport.com/device/K102976
Methodology: https://510kreport.com/methodology