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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 K984311
Device Name NBR4 MILS NITRILE POWDER FREE EXAMINATION GLOVES NON-STERILE
Applicant
Sumirubber Industries (Kedah) Sdn. Bhd.
Lot 44, 45 & 86, Bakar Arang
Industrial Estate
Sungai Petani, Kedah,  MY 08000
Applicant Contact HIDEAKI OCHIAI
Correspondent
Sumirubber Industries (Kedah) Sdn. Bhd.
Lot 44, 45 & 86, Bakar Arang
Industrial Estate
Sungai Petani, Kedah,  MY 08000
Correspondent Contact HIDEAKI OCHIAI
Regulation Number880.6250
Classification Product Code
LZA  
Date Received12/02/1998
Decision Date 02/09/1999
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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