§884.5310. Condom with spermicidal lubricant.
21 C.F.R. § 884.5310
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).
Classification. Class II (performance standards).
Notes, amendments, and revision history
Amendments
[47 FR 49022, Oct. 29, 1982]
Authority
Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 360 l , 371.
Source
Source: 45 FR 12684, Feb. 26, 1980, unless otherwise noted.
Amendments
[47 FR 49022, Oct. 29, 1982]