# K021743: (Multiple Labels) Powder-Free Poly-Vinyl Exam Gloves, Color: Yellow

- Pathway: 510(k) (Traditional)
- Applicant: Copioumed Intl., Inc.
- Decided: Jun 10, 2002 after 13 days
- Product code: LZA (Polymer 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 K992979 (2000). 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)
- K992979: Shanghai Poseidon Powder-Free Synthetic Vinyl Examination Gloves, Yellow, Shanghai Poseidon Plastic Products Co., Ltd. (2000) Summary page 1.
- K002340: Vinyl Examination Glove, Powder-Free, Yellow, Glormed Intl., Inc. (2000)

## 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/K021743
Methodology: https://510kreport.com/methodology