Title 21: Food and Drugs
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/ PART 884 - OBSTETRICAL AND GYNECOLOGICAL DEVICES
/ Subpart F - Obstetrical and Gynecological Therapeutic Devices / § 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).