Cleared Traditional

Durex Polyisoprene Condom

K241617 · Rb Health (Us), LLC · Obstetrics & Gynecology
Feb 2025
Decision
268d
Days
Class 2
Risk

About This 510(k) Submission

K241617 is an FDA 510(k) clearance for the Durex Polyisoprene Condom, a Condom, Synthetic (Class II — Special Controls, product code MOL), submitted by Rb Health (Us), LLC (Parsippany, US). The FDA issued a Cleared decision on February 28, 2025, 268 days after receiving the submission on June 5, 2024. This device falls under the Obstetrics & Gynecology review panel. Regulated under 21 CFR 884.5300.

Submission Details

510(k) Number K241617 FDA.gov
FDA Decision Cleared SESE
Date Received June 05, 2024
Decision Date February 28, 2025
Days to Decision 268 days
Submission Type Traditional
Review Panel Obstetrics & Gynecology (OB)
Summary Statement

Device Classification

Product Code MOL — Condom, Synthetic
Device Class Class II — Special Controls
CFR Regulation 21 CFR 884.5300

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