# K093264: Vinyl Examination Glove, Powder Free, Non-Colored

- Pathway: 510(k) (Traditional)
- Applicant: Qingdao Lang Hui Import & Export Co., Ltd.
- Decided: May 28, 2010 after 221 days
- Product code: LYZ (Vinyl Patient Examination Glove)
- Device class: 1
- Regulation: 21 CFR 880.6250
- Recalls of this device: 3 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device 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.

## Recalls of this device
- Nov 15, 2011 · Not classified · Z-0679-2012: The gloves fail to meet the performance requirements of 21 CFR 800.20 for leakage defects.
- Nov 15, 2011 · Not classified · Z-0680-2012: The gloves fail to meet the performance requirements of 21 CFR 800.20 for leakage defects.
- Nov 15, 2011 · Not classified · Z-0681-2012: The gloves fail to meet the performance requirements of 21 CFR 800.20 for leakage defects.

## Indications for use
A Vinyl examination glove, Powder Free, Clear(Non-Colored) is a 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/K093264
Methodology: https://510kreport.com/methodology