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510(k) Data Aggregation

    K Number
    K242712
    Device Name
    LubriZenzs
    Manufacturer
    SK Zen LLC
    Date Cleared
    2025-06-04

    (268 days)

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

    SK Zen LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    LubriZenzs is a personal lubricant for vaginal and/or penile application, intended to moisturize and lubricate to enhance the ease and comfort of intimate sexual activity, and supplement the body's natural lubrication. This lubricant is compatible with natural rubber latex and polyisoprene condoms. This product is not compatible with polyurethane condoms.
    Device Description
    LubriZenzs is a non-sterile, water-based, over-the-counter personal lubricant that is compatible with natural rubber latex and polyisoprene condoms. Its formulation consists of water, propanediol, cellulose gum, algin, 1,2-hexanediol, sodium hyaluronate, lactic acid, gluconolactone, Tremella fuciformis (mushroom) extract, caprylhydroxamic acid, sodium benzoate, calcium gluconate, sodium hydroxide, xylitylglucoside, anhydroxylitol, glycogen, xylitol, and glucose. The Lubricant comes in a 100 mL white polypropylene plastic airless pump bottle, with a clear overcap. The lubricant has a shelf-life of 2 years. Specifications: - Appearance: Clear, flowable - Color: Colorless - Odor: Odorless - pH: 4.5-5.0 - Viscosity: 10,000 – 25,000 cps - Osmolality: 135 - 380 mOsm/kg (1:10 dilution) - Total Microbial Count (TAMC): < 100 cfu/g - Fungal/Yeast/Mold Limits (TYMC): < 10 cfu/g - Absence of Pathogenic Organisms (Pseudomonas aeruginosa, Staphylococcus aureus, Salmonella, Escherichia coli, Candida albicans): Absent - Antimicrobial Effectiveness: Meets USP <51> criteria for category 2. Bacteria: No less than 2.0 log reduction from initial count at 14 days, and no increase from the 14-day count at 28 days. Yeast and Molds: No increase from the initial calculated count at 14 days and 28 days.
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