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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 K212182
Device Name Iconic Nitrile Glove
Applicant
Iconic Medicare Sdn Bhd
1-2 Jalan Icon City, 14000 Bukit Mertaj
Kuala Lumpur,  MY 14000
Applicant Contact Tan Cho Chia
Correspondent
Integrated Assessment Services Pvt, Ltd.
1495, Manasarovar, 16th Main Rd., Anna Nagar W.
Chennai,  IN 600040
Correspondent Contact A.C. Thirumaran
Regulation Number880.6250
Classification Product Code
LZA  
Date Received07/13/2021
Decision Date 12/11/2021
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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