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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 K900352
Device Name LATEX EXAM GLOVES (SHANGHAI RONGTONG LATEX GLOVES)
Applicant
Sinochem (Usa), Inc.
Two World Trade Center,
Suite 2222
New York,  NY  10048
Applicant Contact LI YOUDHAN
Correspondent
Sinochem (Usa), Inc.
Two World Trade Center,
Suite 2222
New York,  NY  10048
Correspondent Contact LI YOUDHAN
Regulation Number880.6250
Classification Product Code
LYY  
Date Received01/23/1990
Decision Date 03/27/1990
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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