Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

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 the device name listed in this FDA 510(k) record. The listed applicant is Rb Health (Us), LLC. It received FDA 510(k) clearance on 2025-02-28 under 510(k) 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. The listed applicant is Rb Health (Us), LLC. The 510(k) number is K241617.

When did Durex Polyisoprene Condom receive FDA 510(k) clearance?

Durex Polyisoprene Condom received FDA 510(k) clearance on 2025-02-28, under 510(k) number K241617.

Who is the listed applicant for Durex Polyisoprene Condom?

The FDA 510(k) record lists Rb Health (Us), LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Durex Polyisoprene Condom?

The FDA product code for Durex Polyisoprene Condom is MOL.

Other records listing Rb Health (Us), LLC as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K230781Belle SensilubeK213892Grosz Warming Liquid, Grosz Play Tingling, Grosz KY Yours & MineK220489Durex Patronus CloseFit, Durex Patronus RegularK222068Durex Penck III RegularK211152Durex Condom with BenzocaineK213400Grosz Play Aloe, Grosz Play Ylang, Grosz Play Guarana, Grosz Play Cherry, Grosz Play Strawberry

View all 15 devices →

Related Devices (Code: MOL)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K252158Sagami Original 002 Polyurethane Male CondomMayer LaboratoriesK243967ONE Nitrile CondomGlobal Protection Corp.K240379TROJAN SIS Synthetic Latex Condom with Silicone LubricantChurch & Dwight Co., Inc.K240896ONE Nitrile CondomGlobal Protection Corp.K232470Polyisoprene Extra Large CondomSuretex LimitedK23190845 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.

↑