BLUE SAIL (BRAND) POWDERED VINYL PATIENT EXAMINATION GLOVES— 510(k) K032783

Name: FDA 510(k) clearance K032783
Creator: U.S. Food and Drug Administration
Published: 2003-11-13

Substantially Equivalent

Zibo Blue Sail Plastic & Rubber Products Co., Ltd.

FDA 510(k) clearance K032783 for BLUE SAIL (BRAND) POWDERED VINYL PATIENT EXAMINATION GLOVES, Substantially Equivalent on 2003-11-13. Applicant: Zibo Blue Sail Plastic & Rubber Products Co., Ltd.. Device class: 1.

Clearance details

Applicant: Zibo Blue Sail Plastic & Rubber Products Co., Ltd.
Product code: Code LYZ
Device class: Class 1
Regulation: 21 CFR 880.6250
Advisory panel: General Hospital
Date received: 2003-09-08
Decision date: 2003-11-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Chaoyang District; Beijing, CN

Download summary PDF View on FDA.gov ↗

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