LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K062730
    Device Name
    NON-SPERMICIDAL LUBRICATED MALE LATEX CONDOMS
    Manufacturer
    BIOGREEN MEDICAL SDN. BHD.
    Date Cleared
    2006-10-05

    (22 days)

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

    BIOGREEN MEDICAL SDN. BHD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The [No particular brand name] condom is used for contraception and for prophylactic purposes (to help prevent pregnancy and the transmission of sexually transmitted diseases).
    Device Description
    Male Natural Rubber Latex Condom
    Ask a Question

    Ask a specific question about this device

    Page 1 of 1