Durex Polyisoprene Condom
K-Number: K241617 · 2025-02-28
ApplicantRb Health (Us), LLC
Decision Date2025-02-28
Product CodeMOL
Advisory CommitteeOB
DecisionSubstantially Equivalent
Device Summary
Durex Polyisoprene Condom is a medical device manufactured by Rb Health (Us), LLC. It received FDA 510(k) clearance on 2025-02-28 under approval number K241617. The device is classified under product code MOL. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Durex Polyisoprene Condom?
Durex Polyisoprene Condom is a medical device that received FDA 510(k) clearance on 2025-02-28. It is manufactured by Rb Health (Us), LLC. The 510(k) number is K241617.
When was Durex Polyisoprene Condom approved by the FDA?
Durex Polyisoprene Condom received FDA 510(k) clearance on 2025-02-28, under approval number K241617.
What company makes Durex Polyisoprene Condom?
Durex Polyisoprene Condom is manufactured by Rb Health (Us), LLC.
What is the FDA product code for Durex Polyisoprene Condom?
The FDA product code for Durex Polyisoprene Condom is MOL.
Other Devices by Rb Health (Us), LLC
Related Devices (Code: MOL)
K160399Skyn Original Polyisoprene Lubricated Male CondomAnsell Healthcare Products, LLC
K171172Skyn Original Polyisoprene Lubricated Male Condom - FlavoredAnsell Healthcare Products, LLC
K171639Trojan Supra Lubricated Polyurethane Male CondomChurch & Dwight Co., Inc.
K182438Synthetic Polyisoprene Lubricated Male Condom - 5 sensesSxwell USA, LLC
K203541Okamoto 002 Lubricated Polyurethane Male CondomOkamoto USA, Inc.
K23190845 Micron Polyisoprene CondomSuretex Limited
Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.