# K041945: Powder-Free Blue Vinyl Exam Gloves

- Pathway: 510(k) (Traditional)
- Applicant: Glormed Intl., Inc.
- Decided: Aug 20, 2004 after 32 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: 2 generations back to K992979 (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)
- K002340: Vinyl Examination Glove, Powder-Free, Yellow, Glormed Intl., Inc. (2000) Summary page 1.
- K021353: Powder-Free-Vinyl Examination Gloves, Color: White, Glormed Intl., Inc. (2002) Summary page 1.

## 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/K041945
Methodology: https://510kreport.com/methodology