21 C.F.R. § 884.5310 Condom with spermicidal lubricant.
Title 21 - Food and Drugs
(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]
Title 21: Food and Drugs
PART 884—OBSTETRICAL AND GYNECOLOGICAL DEVICES
Subpart F—Obstetrical and Gynecological Therapeutic Devices
§ 884.5310 Condom with spermicidal lubricant.
