# K032071: Powder Free Vinyl Examination Glove

- Pathway: 510(k) (Abbreviated)
- Applicant: Shanghai Foremost Plastic Industrial Co., Ltd.
- Decided: Oct 10, 2003 after 99 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: 1 generation back to K971415 (1997). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K971415: Vinyl Patient Examination Glove, Powder-Free, Shanghai Foremost Plastic Industrial Co., Ltd. (1997) Summary page 1.

## Indications for use
A patient examination glove is a disposable device intended for medical purposes that is worn on the examiners hand or finger to prevent contamination between patient and examiner.

Source page: https://510kreport.com/device/K032071
Methodology: https://510kreport.com/methodology