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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 K941451
Device Name MRG POWDER FREE LATEX EXAMINATION GLOVES
Applicant
M.R.G. Industries Sdn. Bhd.
Pt 4004 Kamunting
Industrial Estate, P.O. Box 9
Kamunting, Perak,  MY 34600
Applicant Contact LAW C K.
Correspondent
M.R.G. Industries Sdn. Bhd.
Pt 4004 Kamunting
Industrial Estate, P.O. Box 9
Kamunting, Perak,  MY 34600
Correspondent Contact LAW C K.
Regulation Number880.6250
Classification Product Code
LYY  
Date Received03/24/1994
Decision Date 06/21/1994
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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