LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K161585
    Device Name
    Mano and Mano Personal Lubricant
    Manufacturer
    Mano and Mano Proprietary Limited
    Date Cleared
    2016-09-06

    (90 days)

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

    Mano and Mano Proprietary Limited

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Mano and Mano Personal Lubricant is a water-based personal lubricant, for penile and/or vaginal application, intended to lubricate and moisturize, 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, polyurethane, and polyisoprene condoms.
    Device Description
    Mano and Mano Personal Lubricant (additionally branded as Nooky, Hello Sailor, or Lulu) is a clear, colorless, water-based personal lubricant composed of purified water, propylene glycol, hydroxethyl cellulose, sodium pyrrolidone carboxylic acid, potassium sorbate and citric acid.
    Ask a Question

    Ask a specific question about this device

    Page 1 of 1