21 CFR § 884.5310 - Condom with spermicidal lubricant.

---
identifier: "/us/cfr/t21/s884.5310"
source: "ecfr"
legal_status: "authoritative_unofficial"
title: "21 CFR § 884.5310 - Condom with spermicidal lubricant."
title_number: 21
title_name: "Food and Drugs"
section_number: "884.5310"
section_name: "Condom with spermicidal lubricant."
chapter_name: "FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES"
subchapter_number: "H"
subchapter_name: "MEDICAL DEVICES"
part_number: "884"
part_name: "OBSTETRICAL AND GYNECOLOGICAL DEVICES"
positive_law: false
currency: "2026-04-05"
last_updated: "2026-04-05"
format_version: "1.1.0"
generator: "[email protected]"
authority: "21 U.S.C. 351, 360, 360c, 360e, 360j, 360, 371."
regulatory_source: "45 FR 12684, Feb. 26, 1980, unless otherwise noted."
cfr_part: "884"
---


# 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]