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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 K991640
Device Name HEALTH AID PREMIUM PRE-POWDERED NITRILE EXAMINATION GLOVES
Applicant
M.R.G. Industries Berhad
Pt 4004 Jalan Perusahaan 3
Kamunting Industrial Estate
Kamunting,  MY 34600
Applicant Contact LIM CHONG
Correspondent
M.R.G. Industries Berhad
Pt 4004 Jalan Perusahaan 3
Kamunting Industrial Estate
Kamunting,  MY 34600
Correspondent Contact LIM CHONG
Regulation Number880.6250
Classification Product Code
LZA  
Date Received05/12/1999
Decision Date 05/28/1999
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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