CFR > Title 21 - Food and Drugs > CHAPTER I—FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES > SUBCHAPTER H—MEDICAL DEVICES (parts 800 to 898) > PART 884—OBSTETRICAL AND GYNECOLOGICAL DEVICES > SUBPART F—Obstetrical and Gynecological Therapeutic Devices (§884.5050 to §884.5970) > 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).

Code of Federal Regulations

[47 FR 49022, Oct. 29, 1982]