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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 K893347
Device Name LATEX EXAMINATION GLOVES
Applicant
CHANGZHOU FOREIGN ECONOMIC TECHNICAL AND TRADING
10-12F YING CHUN BLDG NO. 76
JUQIAN STREET
CHANGZHOU, CHINA,  CN
Applicant Contact ZHU GUOTAO
Correspondent
CHANGZHOU FOREIGN ECONOMIC TECHNICAL AND TRADING
10-12F YING CHUN BLDG NO. 76
JUQIAN STREET
CHANGZHOU, CHINA,  CN
Correspondent Contact ZHU GUOTAO
Regulation Number880.6250
Classification Product Code
LYY  
Date Received04/21/1989
Decision Date 07/14/1989
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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