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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 K890594
Device Name PATIENT EXAMINATION GLOVE
Applicant
Tradexim Sdn Bhd
Lot 4, Solok Hishamuddin Enam
Kawasan 20 42000 Port Klang
Selangor Darul Ehsan,  MY
Applicant Contact KENG BENG
Correspondent
Tradexim Sdn Bhd
Lot 4, Solok Hishamuddin Enam
Kawasan 20 42000 Port Klang
Selangor Darul Ehsan,  MY
Correspondent Contact KENG BENG
Regulation Number880.6250
Classification Product Code
LYY  
Date Received02/06/1989
Decision Date 08/15/1989
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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