Iconic Latex Glove

Latex Patient Examination Glove

Iconic Medicare Sdn Bhd

The following data is part of a premarket notification filed by Iconic Medicare Sdn Bhd with the FDA for Iconic Latex Glove.

Pre-market Notification Details

Device IDK221648
510k NumberK221648
Device Name:Iconic Latex Glove
ClassificationLatex Patient Examination Glove
Applicant Iconic Medicare Sdn Bhd PMT 798, Lingkaran Cassia Selatan, Taman Perindustrian, Bandar Cassia Batu Kawan,  MY 14110
ContactTan Cho Chia
CorrespondentA.C. Thirumaran
Integrated Assessment Services Pvt Ltd 1495, Manasarovar, 16th Main Road, Anna Nagar West Chennai,  IN 600040
Product CodeLYY  
CFR Regulation Number880.6250 [🔎]
DecisionSubstantially Equivalent (SESE)
3rd Party ReviewedNo
Combination ProductNo
Date Received2022-06-07
Decision Date2022-08-25

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