Condom safety is paramount. After all, you need to be certain that the condom you are using has been manufactured and tested to high standards, and is safe to use.
We pride ourselves on our approach to making safe and reliable condoms. All TheyFit condoms are produced in high-tech manufacturing facilities that conform to strict International Standards and ASTM standards and are regularly certified. In fact, the TheyFit production facility produces more than 1 BILLION high quality condoms every year.
Learn more about condom safety and TheyFit below:
Regulated Medical Devices
Condoms are regulated medical devices and must conform to international standards documents such as ISO: 4074. Standards specify what a company must do to test each condom to ensure that it works properly. Condoms must also be cleared for sale by medical regulatory bodies, such as a Notified Body in Europe, the FDA in the US or Health Canada in Canada. The standards stipulate strict controls over quality, testing and materials used during manufacture.
The current International Standard, which was last updated in 2002, mandates a narrow range of condom sizes, including the requirement that all condoms must be 7 inches or longer. TheyFit led efforts to modernize the international regulations by working with medical researchers, manufacturers, standards organizations and non-governmental organizations. The update to ISO: 4074 accommodates an expanded range of condom sizes.
Bringing TheyFit to the United States:
Though a wider range of sizes has been available in other countries, the American standards only allowed for a much smaller number of lengths and widths. TheyFit worked together with the FDA, researchers, and ASTM International over the past few years to prove that the current range of sizes just wasn't enough for a majority of condom users.
In 2015, the FDA granted clearance for an increased range of sizes, making it possible to sell TheyFit in the United States. As a years-long partner of TheyFit, ONE® Condoms acquired the TheyFit Condoms brand in 2016, and is excited to introduce 56 perfect-fit condom sizes to the United States in Fall 2016. These include sizes larger and smaller than anything currently available on the U.S. market, marking a historic shift in the range of condoms that are cleared by the FDA for sale. TheyFit will be rebranded as myONE® Perfect Fit condoms during its U.S. launch in Fall 2016.
TheyFit condoms are made on high tech condom dipping lines at Karex Berhad, the world’s largest and most advanced condom manufacturer. Licensed to export to 110 countries, it has the capacity to manufacture and distribute 4.2 billion pieces annually. Karex’s quality record, technological expertise and global distribution network enables the development of next-generation products. A trusted partner for over 20 years, Karex Berhad purchased a stake in Global Protection Corp., parent company of ONE® condoms, in 2015 for the purpose of expanding the myONE Perfect Fit and ONE brands throughout the world.
The process of making a variety of different sizes is very similar to the way normal condoms are made, except a variety of glass former sizes are used. TheyFit condoms undergo extensive testing just like other condoms do.
Condom testing involves a variety of methods, such as air burst (inflation) testing, water leak testing and electronic testing for holes.
Some methods are used for every condom, while others are used to test samples from each batch. TheyFit condoms have been safety tested using these methods in ways agreed to by the world’s experts and those that are not very narrow or shorter than 7 inches meet the current adopted version of ISO 4074.
The remaining condoms are tested using methodologies developed by the world’s technical experts working closely with TheyFit.
European CE Mark
All TheyFit condoms have a European CE Mark. TheyFit’s medical experts worked with a Notified Body to earn the CE Mark. The CE Mark allows TheyFit to sell its condoms to the 28 countries in the EU - that's nearly 500,000,000 people!
Rest assured we take safety extremely seriously at TheyFit. Through stringent manufacturing processes in some of the most advanced manufacturing facilities in the world, we strive to make the highest quality condoms. Should you have any particular questions about safety of manufacturing, please do contact us directly.