First Condom Authorized For US Market With Anal Sex Indication

The de novo authorization included the creation of a 510(k) pathway for similar devices in the future, allowing other condoms with the same function to reach market more easily.

Condom unrolled to cover a banana.
• Source: Ekaterina Minaeva / Alamy Stock Photo

A condom that is designed to help reduce transmission of sexually transmitted infections during anal intercourse has been cleared for the first time in the US. The authorization comes through a regulatory pathway likely to spur more submissions for condoms carrying the indication

The US Food and Drug Administration has authorized Global Protection Corp.’s One brand natural rubber latex condom to use the...

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