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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 K012711
Device Name DISPOSABLE POWDER FREE VINYL PATIENT EXAMINATION GLOVES
Applicant
SHIJIAZHUANG BRILLIANCE PLASTIC CO., LTD.
17A STERLING RD.
NORTH BILLERICA,  MA  01862
Applicant Contact HUAN CHUNG LI
Correspondent
SHIJIAZHUANG BRILLIANCE PLASTIC CO., LTD.
17A STERLING RD.
NORTH BILLERICA,  MA  01862
Correspondent Contact HUAN CHUNG LI
Regulation Number880.6250
Classification Product Code
LYZ  
Date Received08/14/2001
Decision Date 09/18/2001
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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