FDA 510(k)

ONE Nitrile Condom

K-Number: K240896 · 2024-08-23

Decision Date2024-08-23

Product CodeMOL

Advisory CommitteeOB

DecisionSubstantially Equivalent

Device Summary

ONE Nitrile Condom is a medical device manufactured by Global Protection Corp.. It received FDA 510(k) clearance on 2024-08-23 under approval number K240896. 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 ONE Nitrile Condom?

ONE Nitrile Condom is a medical device that received FDA 510(k) clearance on 2024-08-23. It is manufactured by Global Protection Corp.. The 510(k) number is K240896.

When was ONE Nitrile Condom approved by the FDA?

ONE Nitrile Condom received FDA 510(k) clearance on 2024-08-23, under approval number K240896.

What company makes ONE Nitrile Condom?

ONE Nitrile Condom is manufactured by Global Protection Corp..

What is the FDA product code for ONE Nitrile Condom?

The FDA product code for ONE Nitrile Condom is MOL.

Other Devices by Global Protection Corp.

K193578Non-spermicidal Lubricated Male Latex Condom K203536Male Latex Condom K213087Natural Rubber Latex Ultrasound Transducer Probe Covers DEN210034ONE Male Condom K223214Powder-Free Nitrile Examination Gloves K243972Plain Water-based Lubricant

View all 9 devices →

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.