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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 K161320
Device Name EMG Pink Nitrile Examination Glove Powder Free
Applicant
Eco Medi Glove Sdn. Bhd.
Lot 23826, Jalan Tembaga Kuning
Kamunting Raya Industrial Estate
Taiping,  MY 34600
Applicant Contact Suresh Kumar
Correspondent
Eco Medi Glove Sdn. Bhd.
Lot 23826, Jalan Tembaga Kuning
Kamunting Raya Industrial Estate
Kamunting Perak,  MY 34600
Correspondent Contact Suresh Kumar
Regulation Number880.6250
Classification Product Code
LZA  
Date Received05/11/2016
Decision Date 09/01/2016
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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