(23 days)
The Oasis™ brand condoms are used for contraccption and for prophylactic purposes (to help prevent pregnancy and the transmission of sexually transmitted discascs).
Oasis™ brand Male Natural Rubber Latex Condom, natural and color, silicone lubricated
The provided text is a 510(k) clearance letter from the FDA for a male condom. It does not contain information about acceptance criteria or a study proving the device meets those criteria. The letter primarily confirms that the device is substantially equivalent to a legally marketed predicate device and outlines regulatory requirements for marketing the device, such as labeling and Good Manufacturing Practice.
Therefore, I cannot provide the requested information based on the given text.
To address the prompt, I would need a document that describes:
- Specific performance metrics for the device (e.g., burst strength, leak rate, absence of holes).
- Quantitative acceptance criteria for these metrics.
- Details of a study conducted to test these metrics, including methodology, results, and statistical analysis.
§ 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.