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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 K891374
Device Name PATIENT EXAMINATION GLOVES (LATEX)
Applicant
M.R.G. Industries Sdn. Bhd.
Lot 76, Kulim Indust. Estate
09000 Kulim, Kedah
Malaysia,  MY
Applicant Contact MARK WOON
Correspondent
M.R.G. Industries Sdn. Bhd.
Lot 76, Kulim Indust. Estate
09000 Kulim, Kedah
Malaysia,  MY
Correspondent Contact MARK WOON
Regulation Number880.6250
Classification Product Code
LYY  
Date Received03/09/1989
Decision Date 06/19/1989
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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