POLY (VINYL) EXAM GLOVE, POWDER-FREE— 510(k) K972624

Name: FDA 510(k) clearance K972624
Creator: U.S. Food and Drug Administration
Published: 1997-11-06

Substantially Equivalent

Copioumed Intl., Inc.

FDA 510(k) clearance K972624 for POLY (VINYL) EXAM GLOVE, POWDER-FREE, Substantially Equivalent on 1997-11-06. Applicant: Copioumed Intl., Inc.. Device class: 1.

Clearance details

Applicant: Copioumed Intl., Inc.
Product code: Code LYZ
Device class: Class 1
Regulation: 21 CFR 880.6250
Advisory panel: General Hospital
Date received: 1997-07-14
Decision date: 1997-11-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Green Valley, AZ, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code LYZ

view all

K260860 — Powder Free Synthetic Vinyl Exam Gloves (Blue, Black)2026-04-07
K252467 — Disposable Vinyl Examination Gloves2025-10-27
K252505 — Powder-Free Vinyl Exam Gloves, clear2025-08-28
K241252 — Disposable Vinyl Examination Gloves2024-05-20
K230046 — Vinyl examination gloves2023-03-25

More clearances from Copioumed Intl., Inc.

view all

K030927 — POWDERED VINYL EXAM GLOVES, WHITE2003-04-17
K021961 — POWDER-FREE POLY-VINYL EXAM GLOVES, COLOR: WHITE2002-07-02
K021743 — (MULTIPLE LABELS) POWDER-FREE POLY-VINYL EXAM GLOVES, COLOR: YELLOW2002-06-10
K965237 — NURSES BOUFFANT CAP1997-08-27
K971316 — POLY (VINYL) EXAM GLOVE, POWDERED1997-08-27

Data sourced from openFDA. This site is unofficial and independent of the FDA.