# K042213: Pre-Powdered Non-Sterile Vinyl Examination Gloves

- Pathway: 510(k) (Traditional)
- Applicant: Shandong Perfect Plastic Co., Ltd.
- Decided: Sep 9, 2004 after 24 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.
1 later device descends from it; 1 cites it directly.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K053259: Disposable PVC Examination Glove, Powdered and Powder-Free (2006), 0 descendants of its own

## Indications for use
A pre-powdered patient examination glove is a disposable device intended for medical purpose that is worn on the examiner's hand or finger(s) to prevent contamination between patient and examiner

Source page: https://510kreport.com/device/K042213
Methodology: https://510kreport.com/methodology