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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 K171339
Device Name EMG Blue Nitrile Examination Gloves Powder free with tested for use with chemotherapy Drugs
Applicant
Eco Medi Glove Sdn. Bhd.
Lot 23826, Jalan Tembaga Kuning
Kamunting Raya Industrial Estate
Kamunting Perak,  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  
Subsequent Product Code
LZC  
Date Received05/08/2017
Decision Date 07/07/2017
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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