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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Polymer Patient Examination Glove
510(k) Number K071072
Device Name SHANGHAI CHINA STAR CORP. POWDER FREE BLUE NITRILE PATIENT EXAMINATION GLOVE
Applicant
Shanghai China Star Corp
55 Northern Blvd., Suite 200
Great Neck,  NY  11001
Applicant Contact ROMIL RAMBHIA
Correspondent
Shanghai China Star Corp
55 Northern Blvd., Suite 200
Great Neck,  NY  11001
Correspondent Contact ROMIL RAMBHIA
Regulation Number880.6250
Classification Product Code
LZA  
Date Received04/16/2007
Decision Date 08/30/2007
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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