PRE-POWDERED STERILE SURGEON'S GLOVES (WITH A 50 MICROGRAM/GM PROTEIN CLAIM— 510(k) K021065

Name: FDA 510(k) clearance K021065
Creator: U.S. Food and Drug Administration
Published: 2002-05-08

Substantially Equivalent

Primus Gloves Private , Ltd.

FDA 510(k) clearance K021065 for PRE-POWDERED STERILE SURGEON'S GLOVES (WITH A 50 MICROGRAM/GM PROTEIN CLAIM, Substantially Equivalent on 2002-05-08. Applicant: Primus Gloves Private , Ltd.. Device class: 1.

Clearance details

Applicant: Primus Gloves Private , Ltd.
Product code: Code KGO
Device class: Class 1
Regulation: 21 CFR 878.4460
Advisory panel: General, Plastic Surgery
Date received: 2002-04-02
Decision date: 2002-05-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Kakkanad, Cochin, Kerala, IN

Download summary PDF View on FDA.gov ↗

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