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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Polymer Patient Examination Glove
510(k) Number K980966
Device Name SUPERGLOVES POWDERED NITRILE
Applicant
Supermax Sdn Bhd
Lot 42, Putra Industrial Park
Bukit Rahman Putra
Sungai Pelong, Selangor,  MY 47500
Applicant Contact STANLEY THAI
Correspondent
Supermax Sdn Bhd
Lot 42, Putra Industrial Park
Bukit Rahman Putra
Sungai Pelong, Selangor,  MY 47500
Correspondent Contact STANLEY THAI
Regulation Number880.6250
Classification Product Code
LZA  
Date Received03/16/1998
Decision Date 07/22/1998
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
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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