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510(k) Data Aggregation

    K Number
    K150072
    Device Name
    TheyFit Male Condom
    Manufacturer
    THEYFIT
    Date Cleared
    2015-04-14

    (90 days)

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

    THEYFIT

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The TheyFit male condom is used for contraceptive and for prophylactic purposes (to help prevent pregnancy and the transmission of sexually transmitted infections).
    Device Description
    The TheyFit Male Condom is made of a natural rubber latex sheath, which completely covers the penis with a closely fitted membrane. The condom is shaped with a reservoir end and is flat with a cylindrical shape. TheyFit condoms are available in 34 sizes, of different length/width combinations. TheyFit Condoms are provided pre-lubricated with a silicone-based lubricant. TheyFit condoms are not provided with spermicide. The user must use a fitting kit (FitKit) to select the appropriate size TheyFit Condom.
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    K Number
    K122219
    Device Name
    THEYFIT MALE CONDOM
    Manufacturer
    THEYFIT
    Date Cleared
    2013-09-27

    (429 days)

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

    THEYFIT

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The TheyFit male condom is used for contraceptive and for prophylactic purposes (to help prevent pregnancy and the transmission of sexually transmitted infections).
    Device Description
    The TheyFit Male Condom is made of a natural rubber latex sheath, which completely covers the penis with a closely fitted membrane. The condom is shaped with a reservoir end and is flat with a cylindrical shape. TheyFit condoms are available in 22 sizes, of different length/width combinations. TheyFit Condoms are provided pre-lubricated with a silicone-based lubricant. TheyFit condoms are not provided with spermicide. The user must use a fitting kit (FitKit) to select the appropriate size TheyFit Condom.
    Ask a Question

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