# K971415: Vinyl Patient Examination Glove, Powder-Free

- Pathway: 510(k) (Traditional)
- Applicant: Shanghai Foremost Plastic Industrial Co., Ltd.
- Decided: May 23, 1997 after 36 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
No predicates in its family tree.
2 later devices descend from it; 2 cite it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names no predicate by number.

## Most influential descendants
- K041041: Non Sterile Synthetic Powder Free (Yellow) Vinyl Patient Examination Gloves (2004), 0 descendants of its own
- K032071: Powder Free Vinyl Examination Glove (2003), 0 descendants of its own

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

Source page: https://510kreport.com/device/K971415
Methodology: https://510kreport.com/methodology