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510(k) Data Aggregation

    K Number
    K150153
    Device Name
    Swiss Navy Premium Silicone Lubricant;Swiss Navy Premium Water Based Lubricant;Swiss Navy Premium All Natural Lubricant
    Manufacturer
    Package Solutions LLC
    Date Cleared
    2015-10-20

    (270 days)

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

    Package Solutions LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Swiss Navy Premium Lubricants are personal lubricants 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. These products are compatible with natural rubber latex and polyisoprene condoms. These products are not compatible with polyurethane condoms.
    Device Description
    Swiss Navy® Premium Silicone Lubricant is a non-sterile, silicone-based personal lubricant for use with or without a condom. It is specifically formulated to be a clear, non-irritating, non-greasy and odorless liquid. This device is not a contraceptive, not does it contain any spermicidal components. Swiss Navy Premium Silicone Lubricant comes packaged in the following configurations: 20 ml square PET mini bottle with an aluminized Mylar seal, 2ounce, 4-ounce, 16-ounce, and 32-ounce PET bottles with a pump. All have the cap or pump shrink-wrapped. The 32-ounce PET size contains a travel cap with an aluminized Mylar induction seal. A pump is included with this size. This product also is packaged in 5-ml foil sachets. The specifications for this device include color, odor, viscosity, water activity level, total aerobic microbial count, total yeast and mold count, absence of pathogenic organisms, and specific gravity. Swiss Navy® Premium Water-Based Lubricant is a non-sterile water-based personal lubricant for use with or without a condom. It is clear, non-irritating and non-greasy. It is not a contraceptive, nor does it contain any spermicidal components. Swiss Navy® Premium Water Based into the following configurations: 20 ml square PET mini bottle with ascrew-on cap fitted with an aluminized Mylar seal, 2-ounce, 8-ounce, 16-ounce, and 32-ounce PET bottles with a pump. All have the cap or pump shrink-wrapped. The 32-ounce PET size contains a travel cap with an aluminized Mylar induction seal. A pump is included with this size. This product also is packaged in 5-ml foil sachets. The specifications for this device include pH, osmolality, color, viscosity, water activity level, total aerobic microbial count, total yeast and mold count, absence of pathogenic organisms, and specific gravity.
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