ROMED LATEX SURGICAL GLOVES, POWDERED, STERILE— 510(k) K023139

Name: FDA 510(k) clearance K023139
Creator: U.S. Food and Drug Administration
Published: 2003-10-22

Substantially Equivalent

Van Oostveen Medical B.V.

FDA 510(k) clearance K023139 for ROMED LATEX SURGICAL GLOVES, POWDERED, STERILE, Substantially Equivalent on 2003-10-22. Applicant: Van Oostveen Medical B.V.. Device class: 1.

Clearance details

Applicant: Van Oostveen Medical B.V.
Product code: Code KGO
Device class: Class 1
Regulation: 21 CFR 878.4460
Advisory panel: General, Plastic Surgery
Date received: 2002-09-20
Decision date: 2003-10-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Wilnis, Holland, NL

Download summary PDF View on FDA.gov ↗

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