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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 K894979
Device Name LATEX PATIENT EXAMINATION GLOVES
Applicant
Tower Rubber Industries Sdn. Bhd.
Lot 18, Jalan Lingkaran Sultan
Hishamuddin, Kaw. Perusahaan
Selat Klang Utara, Port Klang,  MY 42000
Applicant Contact KOK MIN
Correspondent
Tower Rubber Industries Sdn. Bhd.
Lot 18, Jalan Lingkaran Sultan
Hishamuddin, Kaw. Perusahaan
Selat Klang Utara, Port Klang,  MY 42000
Correspondent Contact KOK MIN
Regulation Number880.6250
Classification Product Code
LYY  
Date Received08/08/1989
Decision Date 09/12/1989
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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