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    K Number
    K161195
    Device Name
    Royal Condoms (Natural, Black Grape, Coffee, Strawberry, and Chocolate Flavors)
    Manufacturer
    M3 GLOBAL ENTERPRISES, LLC
    Date Cleared
    2016-08-25

    (120 days)

    Product Code
    HIS
    Regulation Number
    884.5300
    Why did this record match?
    Applicant Name (Manufacturer) :

    M3 GLOBAL ENTERPRISES, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Royal Condoms are used for contraceptive and prophylactic purposes (to help prevent pregnancy and the transmission of sexually transmitted infections).
    Device Description
    The subject condoms are made of a natural rubber latex sheath, which completely covers with a closely fitted membrane. They are single use, non-sterile and available in five versions (natural, black grape, coffee, strawberry and chocolate favored). These condoms are of smooth surface, natural colored in cylindrical shape, straight parallel walled with a reservoir nipple at the closed end and a rim at the open end. These condoms have a minimum length of 182mm, width of 53 - 54mm, and wall thickness between 0.065 - 0.075mm, which comply with ISO 4074.
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