LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K103119
    Device Name
    BILLY BOY MALE LATEX CONDOM
    Manufacturer
    SHEILA PICKERING PH.D.
    Date Cleared
    2011-02-24

    (125 days)

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

    SHEILA PICKERING PH.D.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Billy Boy condom is used for contraceptive and for prophylactic purposes (to help prevent pregnancy and the transmission of sexually transmitted infections). The condoms are available in Cylindrical shape, in transparent color and with Nivesse aroma. The models include the BillyBoy, BillyBoy Scented, BillyBoy Special Comfort and BillyBoy Extra Lubricated.
    Device Description
    The BillyBoy 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 Cylindrical. These condoms have a length of 175 -185mm ±10mm, a width of 52.0 -55.0 mm ±2.0mm. The thickness is 0.04-0.08 mm. The air burst test pressure is ≥1 k Pa and air burst test volume is ≥18 dm². The primary packaging material is a foil package. The on surface lubricant is silicon oil.
    Ask a Question

    Page 1 of 1