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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 K100694
Device Name COLORED POWDER FREE AND POLYMER COATED EXAMINATION GLOVE (BLUE, BLACK AND PINK) WITH A PROTEIN CLAIM OF LESS THAN
Applicant
TEKMEDIC (M) SDN BHD
PLOT 4, TANJUNG KLING
INDUSTRIAL AREA, TANJUNG BRUAS
JETTY, TANJUNG KLING, MELAKA,  MY 76400
Applicant Contact PATRICK LEONG
Correspondent
TEKMEDIC (M) SDN BHD
PLOT 4, TANJUNG KLING
INDUSTRIAL AREA, TANJUNG BRUAS
JETTY, TANJUNG KLING, MELAKA,  MY 76400
Correspondent Contact PATRICK LEONG
Regulation Number880.6250
Classification Product Code
LYY  
Date Received03/11/2010
Decision Date 06/25/2010
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
Recalls CDRH Recalls
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