The patootie prophylactics, which will be rolled out by US manufacturer Global Protection Corp., will be marketed as the One Male Condom, the agency said.
The US Food and Drug Administration on Wednesday announced its first-ever authorization of a condom specifically intended for anal sex to help reduce transmission of sexually transmitted infections.
The FDA said that it had never before “cleared or approved condoms specifically indicated for anal intercourse.” “Furthermore, 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,” Lias added.
“The safety and efficacy of the One Male Condom was studied in a clinical trial comprised of 252 men who have sex with men and 252 men who have sex with women,” it explained.
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