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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Vinyl Patient Examination Glove
510(k) Number K032783
Device Name BLUE SAIL (BRAND) POWDERED VINYL PATIENT EXAMINATION GLOVES
Applicant
Zibo Blue Sail Plastic & Rubber Products Co., Ltd.
Rm. 707, Avic Bldg., #2
Dong San Huan Nan Rd.
Chaoyang District; Beijing,  CN 100022
Applicant Contact CHEN YUHONG
Correspondent
Zibo Blue Sail Plastic & Rubber Products Co., Ltd.
Rm. 707, Avic Bldg., #2
Dong San Huan Nan Rd.
Chaoyang District; Beijing,  CN 100022
Correspondent Contact CHEN YUHONG
Regulation Number880.6250
Classification Product Code
LYZ  
Date Received09/08/2003
Decision Date 11/13/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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