21 CFR § 884.5310 Obstetrical and Gynecological Devices

§ 884.5310 Condom with spermicidal lubricant.

Current through Sep 8, 2026 · Read all of Part 884

(a) Identification. A condom with spermicidal lubricant is a sheath which completely covers the penis with a closely fitting membrane with a lubricant that contains a spermicidal agent, nonoxynol-9. This condom is used for contraceptive and prophylactic purposes (preventing transmission of venereal disease).

(b) Classification. Class II (performance standards).

[47 FR 49022, Oct. 29, 1982]

← § 884.5305 External condom for anal intercourse or vaginal intercourse.§ 884.5320 Glans sheath. →