FDA.report

510(k) K241617

Device
Durex Polyisoprene Condom
Applicant
Rb Health (Us), LLC
510(k) number
K241617
Product code
MOL
Decision
Substantially Equivalent (SESE)
Decision date
2025-02-28
Date received
2024-06-05
Regulation
884.5300
Classification name
Condom, Synthetic
Medical specialty
Obstetrics/Gynecology
Review panel
Obstetrics/Gynecology
Device class
2
Clearance type
Traditional
Statement or summary
Statement
Third party reviewed
N

Related Records

Applicant Contact

Contact
Matthew Pleus
Address
399 Interpace Pkwy. Parsippany NJ US 07054 07054

FDA Registration Numbers

Source Documents

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code MOL

510(k)DeviceApplicantDecision date
K252158Sagami Original 002 Polyurethane Male CondomMayer Laboratories2026-03-30
K243967ONE Nitrile CondomGlobal Protection Corp.2025-04-08
K240379TROJAN SIS Synthetic Latex Condom with Silicone LubricantChurch & Dwight Co., Inc.2024-10-08
K240896ONE Nitrile CondomGlobal Protection Corp.2024-08-23
K232470Polyisoprene Extra Large CondomSuretex Limited2024-05-09
K23190845 Micron Polyisoprene CondomSuretex Limited2023-10-27
K203541Okamoto 002 Lubricated Polyurethane Male CondomOkamoto USA, Inc.2022-02-25
K182438Synthetic Polyisoprene Lubricated Male Condom - 5 sensesSxwell USA, LLC2018-12-06
K171172Skyn Original Polyisoprene Lubricated Male Condom - FlavoredAnsell Healthcare Products, LLC2017-08-02
K171639Trojan Supra Lubricated Polyurethane Male CondomChurch & Dwight Co., Inc.2017-08-01
K160399Skyn Original Polyisoprene Lubricated Male CondomAnsell Healthcare Products, LLC2016-07-25
K100767TROJAN SUPRA LUBRICATED POLYURETHANE MALE CONDOMChurch & Dwight Co., Inc.2011-04-05
K072169DUREX SYNTHETIC POLYISOPRENE MALE CONDOMSsl Americas, Inc.2008-06-19
K070800LIFESTYLES LUBRICATED POLYISOPRENE LATEX MALE CONDOMAnsell Healthcare Products, LLC2008-03-06
K050828TROJAN SUPRA LUBRICATED POLYURETHANE MALE CONDOMChurch & Dwight Co., Inc.2006-02-28