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510(k) Data Aggregation

    K Number
    K210208
    Device Name
    Titan Condoms
    Manufacturer
    Titan Condoms LLC
    Date Cleared
    2022-02-17

    (387 days)

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

    Titan Condoms LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Titan Condoms are indicated for use for contraceptive and prophylactic purposes (to help prevent pregnancy and the transmission of sexually transmitted infections).
    Device Description
    Titan Condoms are made of a natural latex sheath which completely covers the penis with a closely fitted membrane. The condom is shaped with a reservoir end and a cylinder shape. Titan condoms are available in a range of sizes, with different length and width combinations. Surface textures include smooth, dotted, and ribbed. Titan Condoms are provided prelubricated with a silicone-based lubricant.
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