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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 K040967
Device Name DISPOSABLE POWDER FREE VINYL EXAMINATION GLOVES
Applicant
Zi BO Hong Wang Plastic & Rubber Products Co. , Ltd.
17a Sterling Rd.
North Billerica,  MA  01862
Applicant Contact HUAN-CHUNG LI
Correspondent
Zi BO Hong Wang Plastic & Rubber Products Co. , Ltd.
17a Sterling Rd.
North Billerica,  MA  01862
Correspondent Contact HUAN-CHUNG LI
Regulation Number880.6250
Classification Product Code
LYZ  
Date Received04/14/2004
Decision Date 06/16/2004
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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