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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 K980071
Device Name SUPERGLOVES LOW PROTEIN POWDER FREE LATEX EXAMINATION GLOVES
Applicant
Supermax Latex Products Sdn. Bhd.
Lot 42, Putra Industrial Park
Bukit Rahman Putra
Sungai Buloh, Selangor,  MY 47000
Applicant Contact STANLEY THAI
Correspondent
Supermax Latex Products 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
LYY  
Date Received01/08/1998
Decision Date 03/13/1998
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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