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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 K010198
Device Name STERILE POWDERED LATEX SURGEON GLOVES
Applicant
Supermax Glove Manufacturing Sdn Bhd
47000 Sungai Buloh
Selangor,  MY
Applicant Contact STANLEY THAI
Correspondent
Supermax Glove Manufacturing Sdn Bhd
47000 Sungai Buloh
Selangor,  MY
Correspondent Contact STANLEY THAI
Regulation Number878.4460
Classification Product Code
KGO  
Date Received01/22/2001
Decision Date 02/23/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
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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