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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Latex Patient Examination Glove
510(k) Number K894080
Device Name LATEX EXAMINATION GLOVES
Applicant
Shanghai Intl. Corp.
One World Trade Center
Suite 2833
New York,  NY  10048
Applicant Contact CHEN LIANQING
Correspondent
Shanghai Intl. Corp.
One World Trade Center
Suite 2833
New York,  NY  10048
Correspondent Contact CHEN LIANQING
Regulation Number880.6250
Classification Product Code
LYY  
Date Received06/08/1989
Decision Date 09/21/1989
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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