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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Condom
510(k) Number K252521
Device Name LifeStyles® HydraFeel Natural Rubber Latex Condom
Applicant
Suretex Limited
31/1 Moo 4, Suratthani-Thakuapha Rd.
Tambon Khao Kwai, Amphur Phunphin
Suratthani,  TH 84130
Applicant Contact Nicolas Coltel
Correspondent
Digangi Consulting, LLC
708 Firethorn Lane
Round Rock,  TX  78664
Correspondent Contact DiGangi Donna
Regulation Number884.5300
Classification Product Code
HIS  
Date Received08/11/2025
Decision Date 11/18/2025
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Summary Summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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