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The One Male Condom was approved through FDA’s De Novo premarket review mechanism.

February 23, 2022

1 Min Read
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Image courtesy of Alamy/Reuters

FDA announced today that it has approved marketing of the first condom specifically indicated for anal intercourse.

Commenting on its first authorization of a condom marketed specifically for anal intercourse, FDA said that the risk of sexually transmitted infections during anal intercourse is significantly higher than during vaginal intercourse. “This authorization helps us accomplish our priority to advance health equity through the development of safe and effective products that meet the needs of diverse populations,” said Courtney Lias, PhD, director of the FDA’s Office of GastroRenal, ObGyn, General Hospital, and Urology Devices in the Center for Devices and Radiological Health.

The One Male Condom was approved through the De Novo premarket review mechanism, which is designed for novel low- to moderate-risk medical products for which there is no predicate device. De Novo classification is a risk-based process, and devices that are classified into Class I or Class II through a De Novo request may be marketed and used as predicates for future premarket notification submissions, explained FDA on its website.

A natural rubber latex sheath, the One Male Condom underwent a clinical trial comprising 252 men who have sex with men and 252 men who have sex with women, reported FDA. The failure rate was 0.68% for anal intercourse and 1.89% for vaginal intercourse.

The One Male Condom is also indicated by FDA as a contraceptive to help reduce the risk of pregnancy and transmission of STIs during vaginal intercourse.

While the majority of condoms are made of rubber latex, polyurethane-based condoms are also on the market. They are much thinner than latex condoms, but are looser fitting and, according to some studies, are more prone to slip off during intercourse.

The One Male Condom is marketed by Global Protection Corp.

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