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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Surgeon'S Gloves
510(k) Number K032467
Device Name MAXTER STERILE POWDERED LATEX SURGICAL GLOVES
Applicant
Maxter Glove Manufacturing Sdn Bhd
6th Miles Off Jalan Meru
Klang Selangor,  MY 41050
Applicant Contact PRISCILLA WEE
Correspondent
Maxter Glove Manufacturing Sdn Bhd
6th Miles Off Jalan Meru
Klang Selangor,  MY 41050
Correspondent Contact PRISCILLA WEE
Regulation Number878.4460
Classification Product Code
KGO  
Date Received08/11/2003
Decision Date 10/10/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General Hospital
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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