One Male Condom

ONE Male Condom is a condom intended for use during anal sex. It received US Food and Drug Administration (FDA) approval on February 23, 2022.[1] All previously approved condoms were only approved for vaginal sex, and had a high failure rate when used off-label for anal sex, both homosexual and heterosexual, increasing the risk of contracting sexually transmitted infections such as HIV.[2][3]

  • It was originally reported that ONE Condoms designed a condom specifically for anal sex. ONE Condoms and MyONE fitted condoms have long been on the market, but in February 2022 received FDA clearance to modify their intended use statement to include anal sex. Condoms have only previously been approved for vaginal sex.
  • ONE Condoms issued a press release noting: "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. As a brand, we like to use "external condom" instead to be inclusive. Our mission is to be a brand for everyONE."[4]
  • ONE and MyONE Condom brands are owned and distributed by Global Protection Corp., a part of the Karex group, the world's largest condom manufacturer.

Availability

MyONE Custom Fit condoms are available at CVS stores nationwide.[5] The sizes available nationwide at CVS were selected based on popularity and represent sizes not otherwise found in-store. “Because we couldn’t take over the entire CVS condom section with 52 sizes, we worked with CVS to choose three of our most popular sizes that would help them better serve their customers,” said Davin Wedel, MyONE®’s founder and president.

ONE Condoms with the FDA anal sex indication are available at Walmart stores in the US.[6] The FDA's approval for an anal sex indication inspired ONE and Walmart to partner with each other on new packaging that highlights the FDA clearance for safer anal sex. The result is the ONE Backdoor Pack, a new three-pack available exclusively at Walmart stores nationwide in the U.S.

References
  1. Alison Hunt (23 February 2022). "FDA Permits Marketing of First Condom Specifically Indicated for Anal Intercourse". fda.gov. U.S. Food and Drug Administration. Retrieved 25 February 2022.
  2. Dress, Brad (25 February 2022). "FDA approves first condom meant for anal sex". The Hill. Washington, DC. Retrieved 25 February 2022.
  3. Nguyen, Brian T.; Nelson, Anita L. (2019). "Time for the US Food and Drug Administration approval of condoms for anal intercourse". EClinicalMedicine. 17: 100226. doi:10.1016/j.eclinm.2019.11.019. PMC 6933260. PMID 31891150.
  4. on, ONE Condoms. "ONE Condoms are first to receive FDA approval for anal sex!". www.onecondoms.com. Retrieved 2022-10-10.
  5. Dec 15, EIN Presswire; 2022; Et, 11:22 Am. "MyONE® Custom Fit™ condoms now available at CVS stores nationwide". Retrieved 2023-02-14.{{cite web}}: CS1 maint: numeric names: authors list (link)
  6. on, ONE Condoms. "The ONE Backdoor Pack is now at Walmart!". www.onecondoms.com. Retrieved 2023-02-14.
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