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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 K013953
Device Name AURELIA CHLORINATED POWDER FREE LATEX MEDICAL EXAMINATION GLOVES WITH ALOE VERA AND GINSENG WITH PROTEIN LABELING CLAIM
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
LYY  
Date Received11/30/2001
Decision Date 02/26/2002
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
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