Search Filters

Search Results

Found 2 results

510(k) Data Aggregation

    K Number
    K150147
    Device Name
    Lubrigyn cream
    Date Cleared
    2015-02-19

    (28 days)

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

    UNIDERM FARMACEUTICI SRL

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    LUBRIGYN CREAM is a personal lubricant, for penile and/or vaginal application, intended to moisturize and lubricate, to enhance the ease and comfort of intimate sexual activity and supplement the body's natural lubrication. This product is not compatible with natural rubber latex, polyisoprene and polyurethane condoms.
    Device Description
    LUBRIGYN CREAM is a non-sterile, non-oily, water based personal lubricant for the intimate vaginal area. LUBRIGYN CREAM is supplied in a 50 mail airless container and can be used daily to supplement the body's natural lubrication when vaginal dryness causes discomfort. The specifications for the LUBRIGYN CREAM include appearance, color, odor, pH, viscosity, density, emulsion stability, osmolality, total microbial count, total yeast and mold count and absence of pathogen organisms (Escherichia Coli, Pseudomonas Aeruginosa, Staphylococcus Aureus, Enterococcus Species, Candida Albicans).
    Ask a Question

    Ask a specific question about this device

    K Number
    K132772
    Device Name
    LUBRIGYN CREAM
    Date Cleared
    2014-08-22

    (351 days)

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

    UNIDERM FARMACEUTICI SRL

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    LUBRIGYN CREAM is a personal lubricant, for penile and/or vaginal application, intended to moisturize and lubricate, to enhance the ease and comfort of intimate sexual activity and supplement the body's natural lubrication. This product is not compatible with natural rubber latex, polyisoprene and polyurethane condoms.
    Device Description
    LUBRIGYN CREAM is a non-sterile, non-oily, water based personal lubricant for the intimate vaginal area. LUBRIGYN CREAM is supplied in single use pouches and can be used daily to supplement the body's natural lubrication when vaginal dryness causes discomfort. The specifications for the LUBRIGYN CREAM include appearance, color, viscosity, density, emulsion stability, osmolality, total microbial count, total yeast and mold count and absence of pathogen organisms (Escherichia Coli, Pseudomonas Aeruginosa, Staphylococcus Aureus, Enterococcus Species, Candida Albicans).
    Ask a Question

    Ask a specific question about this device

    Page 1 of 1