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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 K193121
Device Name GEN 2 Nitrile Examination Glove (Blue) With Low Dermatitis Potential Claim and with tested for use with Chemotherapy Drugs Claims
Applicant
ECO Medi Glove SDN BHD
Lot 23826, Jalan Tembaga Kuning,
Kamunting Raya Industrial Estate,
Perak,  MY 34600
Applicant Contact Suresh Kumar
Correspondent
ECO Medi Glove SDN BHD
Lot 23826, Jalan Tembaga Kuning,
Kamunting Raya Industrial Estate,
Perak,  MY 34600
Correspondent Contact Suresh Kumar
Regulation Number880.6250
Classification Product Code
LZA  
Subsequent Product Code
LZC  
Date Received11/12/2019
Decision Date 03/20/2020
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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