21 C.F.R. § 884.5310
Condom with spermicidal lubricant.
Cite as 21 C.F.R. § 884.5310 (2026)
(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]