(281 days)
The Double Springers Nonoxynol 9 condom, is used for contraception and for prophylactic purposes (to help prevent pregnancy and the transmission of sexually transmitted diseases).
Not Found
The provided text is a letter from the FDA to Medtech Products Limited regarding the substantial equivalence of their "Double Springers Nonoxynol 9 Lubricated Condom." This document is an FDA clearance letter and does not contain the information requested about acceptance criteria, study details, sample sizes, expert qualifications, or ground truth establishment.
The letter confirms that the device is substantially equivalent to legally marketed predicate devices, meaning it meets the regulatory requirements for marketing. However, it does not describe the specific performance characteristics or the studies conducted to demonstrate those characteristics.
Therefore, I cannot provide the requested table and study details based on the given input.
§ 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).