ONE Condoms

ONE Condoms (stylized ONE®) is an American brand of condoms and personal lubricants owned by Global Protection Corp., a manufacturer headquartered in Lynn, Massachusetts. The brand was launched in 2004 by Global Protection Corp., which had been founded in 1987. Since 2020, Global Protection Corp. has operated as a wholly owned subsidiary of Karex Berhad, a Malaysian company widely described as the world's largest condom manufacturer. ONE products include the One Male Condom, which in 2022 became the first condom cleared by the U.S. Food and Drug Administration (FDA) for marketing specifically for anal intercourse; the MyONE Custom Fit line, sized condoms sold in 52 size combinations in the United States; Pleasure Plus, a contoured condom that was the subject of patent litigation in the 2000s; and Glowing Pleasures, a glow-in-the-dark condom.

History

Global Protection Corp. was founded in 1987 by Davin Wedel, then an undergraduate at Tufts University, during a period of increased public health messaging about condom use amid the AIDS epidemic. The company's early business centered on novelty and promotional condom products distributed to colleges, public health organizations, and other groups. Among its early products was a glow-in-the-dark condom marketed as "Knight Light," which the company has described as one of the first products of its kind, later followed by an FDA-cleared glow-in-the-dark line called "Night Light" in the 1990s.

In 2004, the company introduced ONE as a standalone consumer condom brand, distinguished in part by circular foil wrappers rather than the rectangular wrappers used by most competitors. The brand grew to be distributed through major U.S. retailers, including Walmart, CVS, Walgreens, and Costco, as well as through public health agencies.

Karex Berhad acquired an initial 55% stake in Global Protection Corp. in 2014, increased its holding to 70% in 2018, and acquired the remaining shares to make the American company a wholly owned subsidiary in 2020. Karex, based in Malaysia, has been described in press coverage as the largest condom manufacturer in the world by volume. As part of the relationship, Karex's manufacturing capabilities have been used to produce ONE-branded products, including custom machinery built for the brand's round foil wrappers.

One Male Condom and FDA clearance for anal [...]

The One Male Condom is a natural rubber latex condom sold in standard, thin, and fitted (MyONE) versions. On February 23, 2022, the FDA granted a De Novo authorization permitting Global Protection Corp. to market the One Male Condom for use during anal intercourse, in addition to its existing approval for vaginal intercourse. Until that point, all condoms sold in the United States had been evaluated and labeled by the FDA only for vaginal use, meaning their use during anal [...] was technically off-label even though it was common and recommended by public health authorities such as the Centers for Disease Control and Prevention.

The authorization was based on a clinical trial conducted by researchers at Emory University involving 252 men who have [...] with men and 252 men who have [...] with women, which found a total condom failure rate (breakage or slippage) of 0.68 percent for anal intercourse and 1.89 percent for vaginal intercourse. The FDA's decision allows subsequent condom products of the same type to reach market through the agency's faster 510(k) clearance pathway rather than requiring a new De Novo review.

Although the FDA's own materials referred to the product as the "One Male Condom," the company has stated that its brand name is simply "ONE" (or "MyONE" for fitted versions) and that it prefers the term "external condom."

MyONE Custom Fit

MyONE Custom Fit is the only custom sized condom line in the United States, sold in dozens of length-and-width combinations, intended to address fit problems—such as slippage or excessive tightness—that can occur with standard, one-size condoms. As of the mid-2020s, the U.S. version of the product was offered in 52 distinct sizes, determined using a paper measuring template that customers use before ordering. Some of the intellectual property and FDA approvals underlying the fitted-condom line originated with TheyFit LLC, a sized-condom company whose assets Karex acquired in 2016 for incorporation into the MyONE product.

Pleasure Plus and patent litigation

Pleasure Plus is a contoured condom featuring a loose pouch near the tip, designed to increase friction and sensation for the wearer. It was originally developed in the early 1990s by Indian physician A. V. K. Reddy and first marketed by Reddy Laboratories International, a company Reddy controlled. After Reddy's company encountered financial difficulties in the mid-1990s, its assets—chiefly two related condom-design patents—were acquired through bankruptcy proceedings by creditors, who formed a company called Portfolio Technologies, Inc. (PTI) to hold the patents. PTI subsequently licensed production and sale of the Pleasure Plus condom to Global Protection Corp., and Pleasure Plus has continued to be sold under the ONE brand.

Reddy later returned to the condom business through a new venture in India, producing a similarly contoured condom called the Inspiral, and PTI sued to block its import into the United States in 1999; a federal judge in New Jersey declined to issue an injunction, finding PTI was unlikely to succeed on the merits, and an appeals court upheld that outcome while disputing some of the lower court's reasoning. In the mid-2000s, after Reddy struck a deal with Church & Dwight (maker of Trojan condoms) to supply a related design called the Twisted Pleasure, PTI brought new patent-infringement litigation against Church & Dwight, against Reddy's U.S. distributor, and before the U.S. International Trade Commission, arguing that the entry of a major competitor like Trojan into the contoured-condom niche had undercut Pleasure Plus's market position and pricing. Coverage of the case noted that much of the litigation turned on technical questions about whether competing condom designs had a "generally constant diameter" as described in the underlying patent claims.

Glowing Pleasures

Glowing Pleasures is a glow-in-the-dark condom sold under the ONE brand, made with a layer of phosphorescent pigment between layers of latex that, after exposure to light, glows for roughly 15 to 30 minutes. Global Protection Corp. has stated that it produced an early glow-in-the-dark condom called "Knight Light" in 1989 and later obtained FDA clearance for a successor glow-in-the-dark line, Night Light, in the 1990s, before introducing Glowing Pleasures as part of the ONE product range. Some retailers and the company itself describe the product as the first FDA-cleared glow-in-the-dark condom; as with many "first-to-market" claims in the condom industry, this is sourced primarily to the company and its retail partners rather than independent verification.

Ownership and manufacturing

ONE Condoms is a brand of Global Protection Corp., which has been a wholly owned subsidiary of Karex Berhad since 2020, following an initial 2014 investment. Karex, listed on the Malaysian stock exchange, manufactures condoms for numerous global brands and retailers in addition to its own labels. Global Protection Corp.'s other brands have included Trustex, NuVo, Fantasy, Night Light, and Satin Oral Dams.

Global Protection Corp. is headquartered in Lynn, Massachusetts, a city north of Boston that previously housed a major dairy-processing plant in the same facility. Trade and local media have referred to Lynn as the "Condom Capital of the USA" following the company's relocation there.

See also

• Condom
• One Male Condom
• Karex