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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 K892279
Device Name PATIENT EXAMINATION GLOVES
Applicant
Aek Rubber Product Sdn. Bhd.
45 Rockefeller Plz.
Suite 2265
New York,  NY  10020
Applicant Contact MICHAEL Z MATTHEW
Correspondent
Aek Rubber Product Sdn. Bhd.
45 Rockefeller Plz.
Suite 2265
New York,  NY  10020
Correspondent Contact MICHAEL Z MATTHEW
Regulation Number880.6250
Classification Product Code
LYY  
Date Received04/04/1989
Decision Date 12/01/1989
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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