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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 K091147
Device Name POWDER FREE NITRILE EXAMINATION GLOVE (BLUE)
Applicant
Smart Glove Corp. Sdn Bhd
Batu 5 3/4, Jalan Kapar
Klang
Selangor Darul Eshan,  MY 42100
Applicant Contact FOO KHON PU
Correspondent
Smart Glove Corp. Sdn Bhd
Batu 5 3/4, Jalan Kapar
Klang
Selangor Darul Eshan,  MY 42100
Correspondent Contact FOO KHON PU
Regulation Number880.6250
Classification Product Code
LZA  
Date Received04/20/2009
Decision Date 07/27/2009
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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