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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 K020837
Device Name MOTEX LATEX EXAMINATION GLOVES, POWDER-FREE
Applicant
Shanghai Motex Healthcare Co., Ltd.
#6318, Fang Huang Rd., Huaxin
Qingpu, Shanghai,  CN 201708
Applicant Contact TONY T.K. CHENG
Correspondent
Shanghai Motex Healthcare Co., Ltd.
#6318, Fang Huang Rd., Huaxin
Qingpu, Shanghai,  CN 201708
Correspondent Contact TONY T.K. CHENG
Regulation Number880.6250
Classification Product Code
LYY  
Date Received03/14/2002
Decision Date 12/02/2002
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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