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510(k) Data Aggregation

    K Number
    K180828
    Device Name
    Natureplex Warm Touch Warming Jelly
    Manufacturer
    Date Cleared
    2018-12-20

    (265 days)

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

    Natureplex, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Natureplex Warm Touch Warming Jelly 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 compatible with natural rubber latex condoms. This product is not compatible with polyisoprene or polyurethane condoms
    Device Description
    Warm Touch Warming Jelly is a non-sterile, clear, colorless, viscous jelly for use as a personal lubricant. The device is designed to supplement the body's own natural lubrication fluids and is compatible for use with natural rubber latex condoms during intimate sexual activity. The device is not compatible with polyurethane or polyisoprene condoms. The primary packaging for the product is a low-density polyethylene (LDPE) tube with a cap, and peel seal for safety. Each tube is secondarily packaged in a cardboard carton.
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    K Number
    K051963
    Device Name
    BE-CERTAIN PREGNANCY TEST
    Manufacturer
    Date Cleared
    2005-11-23

    (127 days)

    Product Code
    Regulation Number
    862.1155
    Why did this record match?
    Applicant Name (Manufacturer) :

    NATUREPLEX, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The BE CERTAIN™ Home Pregnancy Test is intended for the qualitative identification of the elevated level of Human Chorionic Gonadotrophin (hCG) in urine to aid in the determination of pregnancy. It is for over-the-counter consumer use.
    Device Description
    The BE CERTAIN™ Home Pregnancy Test is an hCG assay, comprising of a rapid one-step test, based on an immunochromatographic technology. The test is made up of a membrane with an absorbent pad overlapping a strip of fiber glass paper that is impregnated with a lyophilized colloidal conjugate of gold particles and monoclonal solid phase antibodies to hCG. Other absorbent pads at the end of the assay absorb excess sample fluid. The urine sample is introduced into the device and proceeds through the absorbent pad, then laterally onto a chromatographic membrane. As it contacts the membrane, the sample dissolves the lyophilized conjugate. In a reactive sample, the hCG antigen will attach to the antibodies in the colloidal solution. As the conjugate moves forward on the membrane, anti-hCG monoclonal antibody affixed on the test zone ("T") will bind the hCG-gold conjugate complex, forming a pink line ("T"). All samples will cause a pink colored line to appear in the control zone ("C"). This line is formed by the binding of the polyclonal antibodies (Anti-mouse IgG) affixed onto the control zone to the sample-colloidal gold conjugate. Presence of this line indicates that the test has been carried out correctly. In less than 5 minutes, levels of hCG as low as 25mlU/ml can be detected.
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