884.5310 Condom with spermicidal lubricant.§ 884.5310 Condom with spermicidal lubricant.
(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]