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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Latex Patient Examination Glove
510(k) Number K221648
Device Name Iconic Latex Glove
Applicant
Iconic Medicare Sdn Bhd
Pmt 798, Lingkaran Cassia Selatan, Taman Perindustrian,
Bandar Cassia
Batu Kawan,  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
LYY  
Date Received06/07/2022
Decision Date 08/25/2022
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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