(83 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 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.
§ 884.5310 Condom with spermicidal lubricant.
(a)
Identification. A condom with spermicidal lubricant is a sheath which completely covers the penis with a closely fitting membrane with a lubricant that contains a spermicidal agent, nonoxynol-9. This condom is used for contraceptive and prophylactic purposes (preventing transmission of venereal disease).(b)
Classification. Class II (performance standards).