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510(k) Data Aggregation

    K Number
    K170797
    Device Name
    wettrust D2care
    Date Cleared
    2017-12-06

    (264 days)

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

    Wettrust Korea Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    wettrust D2care is a personal lubricant for 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 or polyurethane condoms. This product is compatible with synthetic polyisoprene condoms.
    Device Description
    wettrust D2care is a water-based personal lubricant that is packaged in a single use prefilled one-push syringe. The primary ingredients include water, glycerin, and hydroxethylcellulose. The device specifications include appearance, color, odor, pH, viscosity, osmolality, antimicrobial effectiveness, total aerobic microbial count, total yeast and mold count, and absence of pathogenic organisms.
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