(205 days)
A latex rubber condom is intended to be worn over the male penis during acts of vaginal intercourse to aid in the prevention of pregnancy and the spread of sexually transmitted diseases.
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I am sorry, but the provided text is a letter from the FDA regarding the clearance of Durex Colors and Scents Latex Rubber Condoms (K980174). It does not contain information about acceptance criteria, study details, or performance data for a device in the manner requested by your prompt (e.g., sample sizes, expert qualifications, ground truth, or MRMC studies).
The letter confirms that the device is substantially equivalent to legally marketed predicate devices for the indications of preventing pregnancy and the spread of sexually transmitted diseases. However, it does not provide the specific technical acceptance criteria or the study data that would demonstrate how the device meets such criteria.
§ 884.5300 Condom.
(a)
Identification. A condom is a sheath which completely covers the penis with a closely fitting membrane. The condom is used for contraceptive and for prophylactic purposes (preventing transmission of sexually transmitted infections). The device may also be used to collect semen to aid in the diagnosis of infertility.(b)
Classification. (1) Class II (special controls) for condoms made of materials other than natural rubber latex, including natural membrane (skin) or synthetic.(2) Class II (special controls) for natural rubber latex condoms. The guidance document entitled “Class II Special Controls Guidance Document: Labeling for Natural Rubber Latex Condoms Classified Under 21 CFR 884.5300” will serve as the special control. See § 884.1(e) for the availability of this guidance document.