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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 K893284
Device Name LATEX EXAMINATION GLOVES
Applicant
Aliga Export Sdn Bhd
23.04, 23rd Floor Menara Haw Par
Jalan Sultan Ismail
Kuala Lumpur,  MY 50250
Applicant Contact BENG TECK
Correspondent
Aliga Export Sdn Bhd
23.04, 23rd Floor Menara Haw Par
Jalan Sultan Ismail
Kuala Lumpur,  MY 50250
Correspondent Contact BENG TECK
Regulation Number880.6250
Classification Product Code
LYY  
Date Received04/14/1989
Decision Date 07/14/1989
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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