(121 days)
The TROJAN™ Jaguar Male Natural Rubber Latex Condom with Warming and Tingling Lubricant (TM-TBD) is used for contraception and for prophylactic purposes (to help prevent pregnancy and the transmission of sexually transmitted infections).
The TROJAN™ Jaguar Male Natural Rubber Latex Condom with Warming and Tingling Lubricant (TM-TBD) is made of a natural rubber latex sheath, which completely covers the penis with a fitted membrane and has a glycol-based lubricant containing low levels of sensory ingredients applied directly to the condom to create a perception of warming and tingling. The condom is a bulbous shaped condom consistent with ASTM D3492-08 Standard Specifications for Rubber Contraceptives (Male condom) with a reservoir end. The TROJAN™ Jaguar Male Natural Rubber Latex Condom with Warming and Tingling Lubricant (TM-TBD) is designed with ribs on its shank and on its bulb. The condom has a nominal length of 185 mm and a maximum nominal flat-width of 54 mm, measured 30 mm from the open end. The bulbous portion at the closed end of the condom has a flat-width of 65 mm.
The provided text describes the regulatory filing for a male condom and does not contain information about a study proving that an AI-powered device meets acceptance criteria. The document discusses the substantial equivalence of a new condom product (TROJAN™ Jaguar Male Natural Rubber Latex Condom with Warming and Tingling Lubricant) to a predicate device, focusing on its physical characteristics, biocompatibility, and shelf-life, rather than AI performance.
Therefore, I cannot fulfill your request for the specific points related to acceptance criteria and an AI study, as this information is not present in the provided text.
§ 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.