# K071022: Powder-Free Vinyl Examination Gloves

- Pathway: 510(k) (Traditional)
- Applicant: Glormed Colombia S.A.
- Decided: Jul 5, 2007 after 85 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 K981360 (1998). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K983494: Vinyl Exam Gloves, Powder Free, Glormed Intl., Inc. (1998) Summary page 2.

## Indications for use
Based upon 21 CFR §880.6251 "Patient examination glove, powder-free" A patient examination glove is a medical device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner against potentially infectious materials.

Source page: https://510kreport.com/device/K071022
Methodology: https://510kreport.com/methodology