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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name surgeon's gloves
510(k) Number K014230
Device Name STERILE POWDER FREE LATEX SURGEON GLOVES WITH PROTEIN LABELING CLAIM (50 MICROGRAM OR LESS)
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 Number878.4460
Classification Product Code
KGO  
Date Received12/26/2001
Decision Date 03/13/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General Hospital
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
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