# K092294: Vinyl CO-Polmer Free Examination Gloves, Blue Color

- Pathway: 510(k) (Traditional)
- Applicant: Bettercare Plastic Products Co., Ltd.
- Decided: Oct 21, 2009 after 84 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: 3 generations back to K001834 (2000). 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)
- K061562: Vinyl CO-Polymer Powder Free Examination Gloves, Blue Color, Grand Work Plastic Products Co., Ltd. (2006) Summary page 1.

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

Source page: https://510kreport.com/device/K092294
Methodology: https://510kreport.com/methodology