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(121 days)
TROJAN JAGUAR MALE NATURAL RUBBER LATEX CONDOM WITH WARMING AND TINGLING LUBRICANT
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.
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