SYNTHETICARE POWDERED VINYL EXAMINATION GLOVES— 510(k) K030484

Name: FDA 510(k) clearance K030484
Creator: U.S. Food and Drug Administration
Published: 2003-03-06

Substantially Equivalent

Emerald Medical, Inc.

FDA 510(k) clearance K030484 for SYNTHETICARE POWDERED VINYL EXAMINATION GLOVES, Substantially Equivalent on 2003-03-06. Applicant: Emerald Medical, Inc.. Device class: 1.

Clearance details

Applicant: Emerald Medical, Inc.
Product code: Code LYZ
Device class: Class 1
Regulation: 21 CFR 880.6250
Advisory panel: General Hospital
Date received: 2003-02-14
Decision date: 2003-03-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Great Neck, NY, US

Download summary PDF View on FDA.gov ↗

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