21 CFR §884.5310
Verified against eCFR.gov as of June 20, 2026View official text on eCFR.gov ↗
- (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).