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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 K890393
Device Name EXAMINATION GLOVES
Applicant
Sumirubber Industries (Kedah) Sdn. Bhd.
Lot 45 & 86,
Bakar Arang Industrial Estate
Sungai Petani, Kedah,  MY 08000
Applicant Contact SAWADA
Correspondent
Sumirubber Industries (Kedah) Sdn. Bhd.
Lot 45 & 86,
Bakar Arang Industrial Estate
Sungai Petani, Kedah,  MY 08000
Correspondent Contact SAWADA
Regulation Number880.6250
Classification Product Code
LYY  
Date Received01/25/1989
Decision Date 08/10/1989
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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