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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 K071207
Device Name MASTER GUARD NITRILE BLUE POWDERED EXAMINATION GLOVES
Applicant
High Momentum Sdn Bhd
Bandar Bukit Tinggi Klang
Pelabuhan Klang
Selangor Daurl Ehsan,  MY 42100
Applicant Contact HUE K FAH
Correspondent
High Momentum Sdn Bhd
Bandar Bukit Tinggi Klang
Pelabuhan Klang
Selangor Daurl Ehsan,  MY 42100
Correspondent Contact HUE K FAH
Regulation Number880.6250
Classification Product Code
LZA  
Date Received05/01/2007
Decision Date 08/07/2007
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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