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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 K993865
Device Name GREEN PEPPERMINT FLAVORED POWDERED LATEX EXAMINATION GLOVES
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
LYY  
Date Received11/15/1999
Decision Date 01/20/2000
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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