OPUE-E DISPOSABLE POWDER FREE VINYL SYNTHETIC EXAM GLOVES WITH VITAMIN COMPLEX, NOPAL AND LANOLIN— 510(k) K040108

Name: FDA 510(k) clearance K040108
Creator: U.S. Food and Drug Administration
Published: 2004-08-17

Substantially Equivalent

Est International Corporation

FDA 510(k) clearance K040108 for OPUE-E DISPOSABLE POWDER FREE VINYL SYNTHETIC EXAM GLOVES WITH VITAMIN COMPLEX, NOPAL AND LANOLIN, Substantially Equivalent on 2004-08-17. Applicant: Est International Corporation. Device class: 1.

Clearance details

Applicant: Est International Corporation
Product code: Code LYZ
Device class: Class 1
Regulation: 21 CFR 880.6250
Advisory panel: General Hospital
Date received: 2004-01-20
Decision date: 2004-08-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Rancho Cucamonga, CA, US

Download summary PDF View on FDA.gov ↗

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