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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 K222181
Device Name Iconic Blue Nitrile Glove - Tested for use with Chemotherapy Drugs & Fentanyl Citrate
Applicant
Iconic Medicare Sdn Bhd
Pmt 798, Lingkaran Cassia Selatan
Taman Perindustrian Batu Kawan,
Bandar Cassia, Pulau Pinang.,  MY 14110
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  
Subsequent Product Codes
LZC   OPJ   QDO  
Date Received07/22/2022
Decision Date 01/11/2023
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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