SYNTHETIC VINYL EXAMINATION GLOVES, POWDER FREE (AND MULTIPLE LABELS)— 510(k) K111297

Name: FDA 510(k) clearance K111297
Creator: U.S. Food and Drug Administration
Published: 2011-06-16

Substantially Equivalent

Premier Medical Gloves Factory

FDA 510(k) clearance K111297 for SYNTHETIC VINYL EXAMINATION GLOVES, POWDER FREE (AND MULTIPLE LABELS), Substantially Equivalent on 2011-06-16. Applicant: Premier Medical Gloves Factory. Device class: 1.

Clearance details

Applicant: Premier Medical Gloves Factory
Product code: Code LYZ
Device class: Class 1
Regulation: 21 CFR 880.6250
Advisory panel: General Hospital
Date received: 2011-05-09
Decision date: 2011-06-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Weifang, Shandong, CN

Download summary PDF View on FDA.gov ↗

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