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Code of Federal Regulations (Last Updated: July 5, 2024) |
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Title 21 - Food and Drugs |
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Chapter I - Food and Drug Administration, Department of Health and Human Services |
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SubChapter H - Medical Devices |
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Part 884 - Obstetrical and Gynecological Devices |
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Subpart F - Obstetrical and Gynecological Therapeutic Devices |
§ 884.5310 - Condom with spermicidal lubricant.
Latest version.
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§ 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]