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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 K072802
Device Name SINGLE USE, DISPOSABLE, BLUE COLOR, POWDER FREE LATEX PATIENT EXAMINATION GLOVE
Applicant
Ultrawin Sdn Bhd
12-A, Tam,An Ros Jalan Sultan
Abdullah
Teluk Intan,  MY 36000
Applicant Contact SIEW-HOE MAH
Correspondent
Ultrawin Sdn Bhd
12-A, Tam,An Ros Jalan Sultan
Abdullah
Teluk Intan,  MY 36000
Correspondent Contact SIEW-HOE MAH
Regulation Number880.6250
Classification Product Code
LYY  
Date Received10/01/2007
Decision Date 02/29/2008
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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