21 CFR § 884.5310
Condom with spermicidal lubricant
June 25, 2020
(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]