# K092790: Powder-Free Vinyl Patient Examination Gloves

- Pathway: 510(k) (Traditional)
- Applicant: Zibo Boxiang Plastic & Rubber Co., Ltd.
- Decided: Nov 2, 2009 after 53 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: 2 generations back to K942042 (1994). 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)
- K992821: Synthetic Powder-Free Vinyl Patient Examination Gloves, Shijiazhuang Hongxiang Plastics Products Co., Ltd. (2000) Summary page 1.
- (no number) Sunmax Enterprise Shanghai Co., Ltd. Powder-Free Vinyl Patient Examination Gloves, Powder free: named in the summary without a submission number

## Indications for use
A patient examination glove is a disposable device intended for medical purposes that is worn upon the examiner's hands or finger to prevent contamination between patient and examiner (21CFR 880.6250)

Source page: https://510kreport.com/device/K092790
Methodology: https://510kreport.com/methodology