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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 K891503
Device Name PATIENT EXAMINATION GLOVES
Applicant
NEW MODA SDN BHD
279A JALAN MAHKOTA, TAMAN
MALURI
KUALA LUMPUR,  MY 55100
Applicant Contact ANDY GOH
Correspondent
NEW MODA SDN BHD
279A JALAN MAHKOTA, TAMAN
MALURI
KUALA LUMPUR,  MY 55100
Correspondent Contact ANDY GOH
Regulation Number880.6250
Classification Product Code
LYY  
Date Received03/16/1989
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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