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510(k) K252521

LifeStyles® HydraFeel Natural Rubber Latex Condom by Suretex Limited — Product Code HIS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 18, 2025
Date Received
August 11, 2025
Clearance Type
Abbreviated
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Condom
Device Class
Class II
Regulation Number
884.5300
Review Panel
OB
Submission Type

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