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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 K060858
Device Name LATEX POWDERED EXAMINATION GLOVE
Applicant
High Momentum Sdn Bhd
Lot 4960, Jalan Teratai Batu 6
Off Jalan Meru
Klang, Selangor Darul Eshsan,  MY 41050
Applicant Contact HUE K FAH
Correspondent
High Momentum Sdn Bhd
Lot 4960, Jalan Teratai Batu 6
Off Jalan Meru
Klang, Selangor Darul Eshsan,  MY 41050
Correspondent Contact HUE K FAH
Regulation Number880.6250
Classification Product Code
LYY  
Date Received03/29/2006
Decision Date 06/08/2006
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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