SYNTHETIC EXAM GLOVE POWDER FREE COATED WITH ALLOGEL (GREEN/ BLUE / WHITE / MAGENTA / CLEAR - NON COLORED)— 510(k) K103619

Name: FDA 510(k) clearance K103619
Creator: U.S. Food and Drug Administration
Published: 2011-08-10

Substantially Equivalent

Shandong Blue Sail Innovation Co., Ltd.

FDA 510(k) clearance K103619 for SYNTHETIC EXAM GLOVE POWDER FREE COATED WITH ALLOGEL (GREEN/ BLUE / WHITE / MAGENTA / CLEAR - NON COLORED), Substantially Equivalent on 2011-08-10. Applicant: Shandong Blue Sail Innovation Co., Ltd.. Device class: 1.

Clearance details

Applicant: Shandong Blue Sail Innovation Co., Ltd.
Product code: Code LYZ
Device class: Class 1
Regulation: 21 CFR 880.6250
Advisory panel: General Hospital
Date received: 2010-12-10
Decision date: 2011-08-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Weifang, Shandong, CN

Download summary PDF View on FDA.gov ↗

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