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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 K121592
Device Name POWDER FREE BLUE NITRILE EXAMINATION GLOVE TESTED WITH CHEMOTHERAPY DRUGS
Applicant
Tekmedic (M) Sdn Bhd
Plot 4, Tanjung Kling
Industrial Area, Tanjung Bruas
Jetty, Tanjung Kling, Malacca,  MY 76400
Applicant Contact PATRICK LEONG
Correspondent
Tekmedic (M) Sdn Bhd
Plot 4, Tanjung Kling
Industrial Area, Tanjung Bruas
Jetty, Tanjung Kling, Malacca,  MY 76400
Correspondent Contact PATRICK LEONG
Regulation Number880.6250
Classification Product Code
LZA  
Subsequent Product Code
LZC  
Date Received05/31/2012
Decision Date 01/18/2013
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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