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510(k) Data Aggregation

    K Number
    K131887
    Date Cleared
    2013-10-24

    (121 days)

    Product Code
    Regulation Number
    884.5300
    Reference & Predicate Devices
    Why did this record match?
    Device Name :

    TROJAN JAGUAR MALE NATURAL RUBBER LATEX CONDOM WITH WARMING AND TINGLING LUBRICANT

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    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).

    Device Description

    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.

    AI/ML Overview

    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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