# K040916: Vitalcare Powder Free Synthetic Vinyl Examination Glove

- Pathway: 510(k) (Traditional)
- Applicant: Vitalcare Group, Inc.
- Decided: May 4, 2005 after 391 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 K992289 (1999). 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)
- K992289: Vinyl Powdered Exam Glove / Cat.# 15-020, Vitalcare Group, Inc. (1999) Summary page 5.

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

Source page: https://510kreport.com/device/K040916
Methodology: https://510kreport.com/methodology