(84 days)
If used properly, condoms will help to reduce the risk of transmission of HIV infection (AIDS) and many other sexually transmitted diseases, including chlamydia, genital herpes, genital warts, gonorrhea, hepatitis B and syphilis. Condoms, when properly used, are highly effective against pregnancy although no contraceptive can guarantee 100% effectiveness. Any use of this condom for other than vaginal intercourse can increase the potential damage to the condom. For maximum pleasure and protection, it is important to follow the instructions for use included inside this package. Failure to do so may result in the loss of the benefits of the condom.
Latex Condoms, Natural Color with Silicone Oil Lubricant
I am sorry, but the provided text from the FDA 510(k) notifications (K974323) for "Latex Condoms, Natural Color with Silicone Oil Lubricant" does not contain information about acceptance criteria, device performance studies, sample sizes, expert qualifications, or multi-reader multi-case studies.
This document is a letter from the FDA confirming the substantial equivalence of the device to previously marketed devices and an "Indications for Use" statement. It does not include the detailed technical and clinical study information that your request is asking for.
Therefore, I cannot provide the requested table and information based on the given input.
§ 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.