# K032190: Disposable Powdered Vinyl Exam Gloves

- Pathway: 510(k) (Traditional)
- Applicant: Synmertex Co, Ltd.
- Decided: Aug 14, 2003 after 28 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. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K082444: Disposable Vinyl Examination Glove, Powdered (2008), 0 descendants of its own
- K072472: Disposable Vinyl Examination Glove, Powdered (2007), 0 descendants of its own

## Indications for use
A PATIENT EXAMINATION GLOVE IS A DISPOSABLE DEVICE INTENDED FOR MEDICAL PURPOSE THAT IS WORN ON THE EXAMINER’S HAND OR FINGERS TO PREVENT CONTAMINATION BETWEEN PATIENT AND EXAMINER.

Source page: https://510kreport.com/device/K032190
Methodology: https://510kreport.com/methodology