Boston-based company is selling custom-fit condoms. They say their product provides more pleasure and protection, but there’s no scientific data yet.

Could making a better condom just mean making one that fits correctly?

Recent changes by the Food and Drug Administration (FDA) will allow for a variety of sizes of condoms to be sold on the market.

Among them, Boston-based Global Protection Corp. has been rolling out custom-fit condoms in 60 different sizes.

The company’s myONE Perfect Fit brand condoms use combinations of 10 different lengths and nine circumferences.

Company officials said their products are better suited for pleasure and protection than the standard condom.

“Although previously existing condoms had some variability in length, there were very limited options for girth,” Davin Wedel, the founder and chief executive officer for Global Protection Corp., told Healthline.

“That means if someone has a thicker than average penis, they won’t notice a significant improvement with existing XL condoms,” he added.

A study from 2014 of 1,661 men living in the United States found that 83 percent of subjects had a penis length shorter than the standard condom, with an average length of 5.57 inches.

“When it comes to length, most condoms are nearly 7 inches long — more than 1 inch longer than the average penis,” said Wedel.

The myONE Perfect Fit condoms are sized from 4.9 to 9.4 inches in length and 3.5 to 5 inches in circumference.

The standard condom runs between 6.7 to 8.3 inches in length and 3.9 to 4.5 inches in circumference.

Size, Wedel said, is a major factor in just about all the negative associations men (and women) have with condoms.

These include feeling too tight, lack of sensation, slippage, breakage, failure to keep an erection, and inability to orgasm.

All of which can lead to the device functioning improperly or potentially leading to the decision not to use one at all.

Today, only one in three men in the United States use condoms during sex, a 2017 study found.

Wedel pointed out other studies about condoms that may shed some light on why that is.

A 2010 study concluded that men wearing improperly fitting condoms had more difficulty with achieving an orgasm and maintaining an erection.

They were also more likely to remove the condom prematurely.

Another study praised fitted condoms, particularly for men with larger than average penises.

If you’ve ever experimented with different condoms and felt like they all seem about the same size, well, you’re right.

Condom size is strictly regulated by the FDA because of its classification as a Class II medical device in 1937.

FDA classes are used to assess the risk of a product — with Class I (dental floss, for example) being the lowest risk and Class III (an artificial heart valve) being the highest.

Condoms have to meet guidelines as well, including tests like how much water or air they can hold before bursting.

“Establishing new testing standards for an expanded range of condom sizes took nearly seven years of effort among researchers, standards organizations, and our R&D and manufacturing experts,” said Impola.

In 2015, the FDA finally allowed for an expanded range of condom sizes to be tested.

The regulations were then codified in the ASTM D3492-16 in August 2016.

Condom design has come up continually in the past few years.

In fact, the Bill and Melinda Gates Foundation began a competition in 2013 to create a better designed condom.

The project has yet to successfully bring one to market.

But, that’s not for lack of effort.

The Gates Foundation has awarded condom entrepreneurs grants for collagen condoms, made from cow tendon or fish skin, and antioxidant-infused condoms that supporters said will increase stimulation and pleasure.

Meanwhile, other questionable innovations are sold under the radar without FDA approval.

The Galactic Cap fits over just the tip of the penis and attaches with a medical adhesive.

The Jiftip is a sticker that covers the urethra to prevent ejaculation. The makers of the device don’t claim it prevents pregnancy or STDs. It’s sold as a novelty.

Whether or not custom-fitted condoms become the next breakthrough in sexual health and safe sex, remains to be seen.

There’s no clinical data at this point that shows increased efficacy or pleasure.

A spokesperson for Planned Parenthood didn’t respond to a request from Healthline for the organization’s stance on custom-fitted condoms.

Despite the dearth of hard evidence about the product, Wedel said that response has been overwhelmingly positive.

He said that within four hours of launch, all 60 different sizes had sold, although those with a larger circumference have been more popular.