Microthin Natural Rubber Latex Condom


Suretex Limited

The following data is part of a premarket notification filed by Suretex Limited with the FDA for Microthin Natural Rubber Latex Condom.

Pre-market Notification Details

Device IDK213921
510k NumberK213921
Device Name:Microthin Natural Rubber Latex Condom
Applicant Suretex Limited 31/1 Moo 4, Suratthani-Thakuapha Road Tambon Khao Hua Kwai, Amphur Phunphin,  TH 84130
ContactKc Nguyen
CorrespondentCarole C. Carey
C3-Carey Consultants, LLC 9451 Ellsworth Court Fulton,  MD  20759
Product CodeHIS  
CFR Regulation Number884.5300 [🔎]
DecisionSubstantially Equivalent (SESE)
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-12-15
Decision Date2022-04-28

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