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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 K981893
Device Name HEALTH + AID PREMIUM PRE-POWDERED LATEX EXAMINATION GLOVES
Applicant
M.R.G. Industries Sdn. Bhd.
Pt. 4004, Jalan Perusahaan 3
Kamunting Indu. Estate, Box 9
Kamunting, Perak,  MY 34600
Applicant Contact SEE KHEK GOH
Correspondent
M.R.G. Industries Sdn. Bhd.
Pt. 4004, Jalan Perusahaan 3
Kamunting Indu. Estate, Box 9
Kamunting, Perak,  MY 34600
Correspondent Contact SEE KHEK GOH
Regulation Number880.6250
Classification Product Code
LYY  
Date Received05/29/1998
Decision Date 06/22/1998
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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