Search Results

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.

Ask a specific question about this device

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 Condom, Colored, with Spermicidal Lubricant

This document is a FDA 510(k) clearance letter for a "Latex Condom, Colored, with Spermicidal Lubricant" (K974326). It does not contain information about acceptance criteria, study designs, sample sizes, or expert qualifications for a medical device's performance study.

The letter explicitly states: "We have reviewed your Section 510(k) notification of intent to market the device and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976,".

This means the device was cleared based on substantial equivalence to a predicate device, not on a new study demonstrating its performance against specific acceptance criteria.

Therefore, I cannot provide the requested information from the provided text.

Ask a specific question about this device