Durex Polyisoprene Condom— 510(k) K241617

Substantially Equivalent

Rb Health (Us), LLC

FDA 510(k) clearance K241617 for Durex Polyisoprene Condom, Substantially Equivalent on 2025-02-28. Applicant: Rb Health (Us), LLC. Device class: 2.

Clearance details

Applicant: Rb Health (Us), LLC
Product code: Code MOL
Device class: Class 2
Regulation: 21 CFR 884.5300
Advisory panel: Obstetrics/Gynecology
Date received: 2024-06-05
Decision date: 2025-02-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Parsippany, NJ, US

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.