DISPOSABLE POWDER FREE VINYL EXAM GLOVES— 510(k) K031113

Name: FDA 510(k) clearance K031113
Creator: U.S. Food and Drug Administration
Published: 2003-06-10

Substantially Equivalent

Elite International, Inc.

FDA 510(k) clearance K031113 for DISPOSABLE POWDER FREE VINYL EXAM GLOVES, Substantially Equivalent on 2003-06-10. Applicant: Elite International, Inc.. Device class: 1.

Clearance details

Applicant: Elite International, Inc.
Product code: Code LYZ
Device class: Class 1
Regulation: 21 CFR 880.6250
Advisory panel: General Hospital
Date received: 2003-04-08
Decision date: 2003-06-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Rowland Heights, CA, US

Download summary PDF View on FDA.gov ↗

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