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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 K024083
Device Name GREEN POWDER FREE NITRILE MEDICAL EXAMINATION GLOVES WITH PEPPERMINT FLAVOR
Applicant
Supermax Glove Manufacturing Sdn Bhd
Lot 42, Putra Industrial Park
Bukit Rahman Putra
Sungai Buloh, Selangor,  MY 47000
Applicant Contact STANLEY THAI
Correspondent
Supermax Glove Manufacturing Sdn Bhd
Lot 42, Putra Industrial Park
Bukit Rahman Putra
Sungai Buloh, Selangor,  MY 47000
Correspondent Contact STANLEY THAI
Regulation Number880.6250
Classification Product Code
LZA  
Date Received12/11/2002
Decision Date 01/10/2003
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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