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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Polymer Patient Examination Glove
510(k) Number K061505
Device Name POWERED NITRILE BLUE EXAMINATION GLOVES
Applicant
Liwe Trading
49,Jalan Ss 2/19
47300 Petaling Jaya
Selangor Darul Ehsan,  MY 47300
Applicant Contact K M LEE
Correspondent
Liwe Trading
49,Jalan Ss 2/19
47300 Petaling Jaya
Selangor Darul Ehsan,  MY 47300
Correspondent Contact K M LEE
Regulation Number880.6250
Classification Product Code
LZA  
Date Received06/01/2006
Decision Date 04/09/2007
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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