ECLIPSE LATEX POWDER FREE STERILE SURGEON'S GLOVE— 510(k) K050533

Name: FDA 510(k) clearance K050533
Creator: U.S. Food and Drug Administration
Published: 2005-04-26

Substantially Equivalent

Regent Medical Americas, LLC

FDA 510(k) clearance K050533 for ECLIPSE LATEX POWDER FREE STERILE SURGEON'S GLOVE, Substantially Equivalent on 2005-04-26. Applicant: Regent Medical Americas, LLC. Device class: 1.

Clearance details

Applicant: Regent Medical Americas, LLC
Product code: Code KGO
Device class: Class 1
Regulation: 21 CFR 878.4460
Advisory panel: General, Plastic Surgery
Date received: 2005-03-02
Decision date: 2005-04-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Norcross, GA, US

Download summary PDF View on FDA.gov ↗

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