# K983494: Vinyl Exam Gloves, Powder Free

- Pathway: 510(k) (Traditional)
- Applicant: Glormed Intl., Inc.
- Decided: Nov 5, 1998 after 31 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 K981360 (1998). 1 ancestor in all.
2 later devices descend from it; 2 cite it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K981360: Vinyl Patient Examination Glove, Powdered, Glormed Intl., Inc. (1998). Cleared while this submission was under review Summary page 1.

## Most influential descendants
- K091471: Patient Examination Gloves, Powder-Free Vinyl (2009), 0 descendants of its own
- K071022: Powder-Free Vinyl Examination Gloves (2007), 0 descendants of its own

## Indications for use
A patient examination glove 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/K983494
Methodology: https://510kreport.com/methodology