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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 K021058
Device Name SYNTEX POWDER-FREE MULTI-PLY LATEX EXAMINATION GLOVES WITH LOW PROTEIN CLAIM
Applicant
SYNTEX HEALTHCARE PRODUCTS CO. LTD.
NO. 1 FANJIAZHUNG INDUSTRIAL
ZONE
XINJI CITY, HEBEI PROVINCE,  CN 052360
Applicant Contact TAN SWU CHOON
Correspondent
SYNTEX HEALTHCARE PRODUCTS CO. LTD.
NO. 1 FANJIAZHUNG INDUSTRIAL
ZONE
XINJI CITY, HEBEI PROVINCE,  CN 052360
Correspondent Contact TAN SWU CHOON
Regulation Number880.6250
Classification Product Code
LYY  
Date Received04/02/2002
Decision Date 05/14/2002
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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