How We Did It
As easy as it sounds to just start making condoms in different sizes, there’s a lot more to it. Because condoms are classified as medical devices, they go through rigorous testing prior to sale and must meet standards set by ASTM International, a global standards development organization.
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.
We believe that condom fit is the next great frontier when it comes to increasing use and acceptability. So we worked with the FDA, researchers, and the ASTM over the past few years to prove that the current range of sizes just wasn't enough for a majority of condom users. We view this as a public health risk – if condoms are improperly sized or uncomfortable, people avoid using them.
In 2015 the FDA granted clearance for an increased range of sizes, making it possible for us to sell myONE in the United States. We’re very excited to bring this solution to millions of men who are frustrated by condoms that just don’t work for their bodies.