Polyisoprene Extra Large Condom
K-Number: K232470 · 2024-05-09
ApplicantSuretex Limited
Decision Date2024-05-09
Product CodeMOL
Advisory CommitteeOB
DecisionSubstantially Equivalent
Device Summary
Polyisoprene Extra Large Condom is a medical device manufactured by Suretex Limited. It received FDA 510(k) clearance on 2024-05-09 under approval number K232470. 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 Polyisoprene Extra Large Condom?
Polyisoprene Extra Large Condom is a medical device that received FDA 510(k) clearance on 2024-05-09. It is manufactured by Suretex Limited. The 510(k) number is K232470.
When was Polyisoprene Extra Large Condom approved by the FDA?
Polyisoprene Extra Large Condom received FDA 510(k) clearance on 2024-05-09, under approval number K232470.
What company makes Polyisoprene Extra Large Condom?
Polyisoprene Extra Large Condom is manufactured by Suretex Limited.
What is the FDA product code for Polyisoprene Extra Large Condom?
The FDA product code for Polyisoprene Extra Large Condom is MOL.
Related Clinical Trials
Other Devices by Suretex Limited
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.