# K082444: Disposable Vinyl Examination Glove, Powdered

- Pathway: 510(k) (Traditional)
- Applicant: Rich Mountain Medical Products, Inc.
- Decided: Sep 30, 2008 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
Longest line of descent: 1 generation back to K032190 (2003). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K032190: Disposable Powdered Vinyl Exam Gloves, Synmertex Co, Ltd. (2003) Summary page 1.

## Indications for use
A PATIENT EXAAIINATION GLOVES 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/K082444
Methodology: https://510kreport.com/methodology