(90 days)
Extra strength nonlubricated rubber male condom for use as a contraceptive and prophylactic.
Additional Statement: "Laboratory tests of physical properties show the ExtraWear condom is stronger than required by the ASTM standard. The breakage rate during sex has not been tested."
ExtraWear™, Gentlemen's Choice™, Extra Strength ... ... Non-Lubricated Latex Condom
I am sorry, but the provided text does not contain the information required to answer your request. The document is an FDA clearance letter for a condom and does not describe any specific acceptance criteria or a study proving that a device meets those criteria. It mainly focuses on the substantial equivalence determination for the condom.
§ 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.