(91 days)
This latex condom has the same intended use as the predicate condoms. The condom is used for contraception and for prophylactic purposes (to help prevent pregnancy and the transmission of sexually transmitted diseases).
This condom is made of a natural rubber latex sheath, which completely covers the penis with a closely fitted membrane. This device is a parallel sided, teat ended, lubricated condom and is designed to conform to national and international voluntary standards, including ISO 4074, EN600 and ASTM D3492.
The provided text describes the Durex studded/ribbed Latex Condom Premarket approval [510(k)], but it does not contain the detailed information required to describe the acceptance criteria and the study that proves the device meets those criteria.
Specifically, the document states: "The Durex latex condoms conforms to the ASTM D3492, ISO 10993 and ISO 4074:2002 standards, except were variances are noted. Conformance to these standards is described on the following pages." and "All physical testing and final release testing revealed results in conformance with required specifications."
However, these "following pages" or the "required specifications" that would detail the specific acceptance criteria (e.g., burst pressure, freedom from holes, length, width) and the results of the studies performed to meet those criteria are not included in the provided text.
Therefore, I cannot fulfill your request for the detailed table and study information based on this input.
To answer your request, the following information would be needed from the full 510(k) submission:
- Specific acceptance criteria: The numerical thresholds for each physical and performance test outlined in ASTM D3492, ISO 10993, and ISO 4074:2002 that the device must meet.
- Reported device performance: The actual test results obtained for the Durex studded/ribbed Latex Condom against each of those specific criteria.
- Details of the study/testing methodology: This would include information on sample size, data provenance, and how ground truth was established, if applicable for the specific tests conducted (e.g., burst pressure, holes, dimensions).
Without this specific content from the mentioned "following pages," any attempt to fill in the table and study details would be speculative and not based on the provided document.
§ 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.