LogoFDA 510(k) Search
Search Filters

Search Results

Found 2 results

510(k) Data Aggregation

    K Number
    K972836
    Device Name
    ROYALE BRAND LATEX CONDOMS-SPERMICIDAL LUBRICANT - COLORED OR ASSORTED COLORS
    Manufacturer
    G. PREMJEE (USA), INC.
    Date Cleared
    1997-10-22

    (83 days)

    Product Code
    LTZ
    Regulation Number
    884.5310
    Why did this record match?
    Applicant Name (Manufacturer) :

    G. PREMJEE (USA), INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The intended use of this condom is for contraception and prophylactic purposes (preventing transmission of venereal diseases).
    Device Description
    A condom with a spermicidal lubricant is a sheath which covers the penis with a closely fitted membrane with a lubricant that contains a spermicidal agent, nonoxynol-9.
    Ask a Question

    Ask a specific question about this device

    K Number
    K971132
    Device Name
    ROYALE BRAND LATEX CONDOMS (SILICONE)-COLORED/ASSORTED COLORS
    Manufacturer
    G. PREMJEE (USA), INC.
    Date Cleared
    1997-09-03

    (160 days)

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

    G. PREMJEE (USA), INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The intended use of this condom is for contraception and prophylactic purposes (preventing transmission of venereal diseases).
    Device Description
    A condom is a sheath which completely covers the penis with a closely fitting membrane.
    Ask a Question

    Ask a specific question about this device

    Page 1 of 1