One Male Condom is a natural rubber latex condom product specifically intended, evaluated and marketed for use during anal sex, as well as being approved for use as a contraceptive and to reduce the risk of sexually transmitted infections (STIs) by vaginal sex. It received US Food and Drug Administration (FDA) approval to be marketed for anal sex use on February 23, 2022. All previous FDA condom approvals were specifically only approvals for use with vaginal sex, and thus their use was off-label for anal sex. When used for anal sex, the One Male Condom product is intended to be used with a compatible water-based personal lubricant.
The labeling on the packages refers to the condom brand as "ONE" (for general-use condoms) or "MyONE" (for fitted condoms) and does not include the word "Male" (or even "condoms") as part of the brand name. On the day of the FDA approval, the company issued a press release that, in addition to celebrating the approval, said "Our brand is ONE Condoms, not 'One Male Condom'. FDA still uses 'male condom' as a term, and listed us as 'One Male Condom' in their press release."
The product is made by Global Protection Corp., a formerly separate company based in Boston, Massachusetts, and founded in 1987 by two Tufts University students. Since 2016, Global Protection Corp. has been majority-owned by the Malaysian condom manufacturer Karex, and it took over full ownership in 2020. As of 2020, Karex is the world's largest producer of condoms.