One Male Condom is a

natural rubber Rubber, also called India rubber, latex, Amazonian rubber, ''caucho'', or ''caoutchouc'', as initially produced, consists of polymers of the organic compound isoprene, with minor impurities of other organic compounds. Types of polyisoprene ...

latex condom product specifically intended, evaluated and marketed for use during

anal sex Anal sex or anal intercourse principally means the insertion and pelvic thrusting, thrusting of the Erection, erect human penis, penis into a person's Human anus, anus, or anus and rectum, for sexual pleasure.Sepages 270–271for anal sex inform ...

, as well as being approved for use as a

contraceptive Birth control, also known as contraception, anticonception, and fertility control, is the use of methods or devices to prevent pregnancy. Birth control has been used since ancient times, but effective and safe methods of birth control only be ...

and to reduce the risk of

sexually transmitted infection A sexually transmitted infection (STI), also referred to as a sexually transmitted disease (STD) and the older term venereal disease (VD), is an infection that is Transmission (medicine), spread by Human sexual activity, sexual activity, e ...

s (STIs) by

vaginal sex In mammals and other animals, the vagina (: vaginas or vaginae) is the elastic, muscular reproductive organ of the female genital tract. In humans, it extends from the vulval vestibule to the cervix (neck of the uterus). The vaginal int ...

. It received US

Food and Drug Administration The United States Food and Drug Administration (FDA or US FDA) is a List of United States federal agencies, federal agency of the United States Department of Health and Human Services, Department of Health and Human Services. The FDA is respo ...

(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 Off-label use is the use of pharmaceutical drugs for an unapproved indication (medicine), indication or in an unapproved age group, dose (biochemistry), dosage, or route of administration. Both prescription drugs and over-the-counter drugs (OTCs) ca ...

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 Personal lubricants (colloquially termed lube) are specialized lubricants used during sexual acts, such as intercourse and masturbation, to reduce friction to or between the penis and vagina, anus or other body parts, or applied to sex toys to ...

. 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 1 (one, unit, unity) is a number, numeral, and glyph. It is the first and smallest positive integer of the infinite sequence of natural numbers. This fundamental property has led to its unique uses in other fields, ranging from science to sp ...

, 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 Boston is the capital and most populous city in the Commonwealth (U.S. state), Commonwealth of Massachusetts in the United States. The city serves as the cultural and Financial centre, financial center of New England, a region of the Northeas ...

, and founded in 1987 by two

Tufts University Tufts University is a private research university in Medford and Somerville, Massachusetts, United States, with additional facilities in Boston and Grafton, as well as Talloires, France. Tufts also has several Doctor of Physical Therapy p ...

students. Since 2016, Global Protection Corp. has been majority-owned by the Malaysian condom manufacturer

Karex Karex Berhad is a Malaysian condom manufacturer, one of the largest in the world. It produces more than five billion condoms a year and one in every five condoms globally. The company also supplies condoms to marketing brands like Durex. Operatio ...

, and it took over full ownership in 2020. As of 2020, Karex is the world's largest producer of condoms.

Variations

Three basic versions of the One brand condom are produced, called standard, thin and fitted. The fitted condoms are available in more than 50 different sizes, and a paper template is provided to assist with identifying the best fitted size for each user, selecting among 10 lengths and 9 widths.

Efficacy

The study of efficacy included evaluation of condom failures, discomfort, STIs, and

urinary tract infection A urinary tract infection (UTI) is an infection that affects a part of the urinary tract. Lower urinary tract infections may involve the bladder (cystitis) or urethra (urethritis) while upper urinary tract infections affect the kidney (pyel ...

s (UTIs). The results were described in an FDA press release, saying: Trial participants were specifically instructed to use a water-soluble lubricant with each act of anal intercourse an instruction that was not given for acts of vaginal intercourse. When used with an appropriate lubricant, a lower failure rate is expected for latex condoms like the One Male Condom than for polyurethane condoms, and the failure rates are not expected to differ between acts of anal versus vaginal intercourse.

References

{{reflist Condoms Prevention of HIV/AIDS