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510(k) Data Aggregation

    K Number
    K222175
    Device Name
    Bloomi Delight Oil-Based Personal Lubricant
    Manufacturer
    The Bloomi Inc..
    Date Cleared
    2022-11-15

    (117 days)

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

    The Bloomi Inc..

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Bloomi Delight Oil-Based Personal Lubricant is a personal lubricant for penile and/or vaginal application, intended to lubricate, moisturize, and 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
    The Bloomi Delight Oil-Based Personal Lubricant is a non-sterile, oil-based, overthe-counter use personal lubricant that is intended for penile and vaginal application to moisturize and lubricate, to enhance the ease and comfort of intimate sexual activity and supplement the body's natural lubrication. The product is not compatible with natural rubber latex, polyurethane and polyisoprene condoms. Its formulation consists of Extra Virgin Coconut Oil, Organic Sunflower Seed Oil, Organic Cocoa Butter, Shea Butter (low melt), Sunflower Wax and Sea Buckthorn Fruit Oil. The Bloomi Delight Oil-Based Personal Lubricant is packaged in a 3 oz tube and is secondarily packaged in an outer box.
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    K Number
    K221328
    Device Name
    Bloomi Smooth Water Based Lubricant
    Manufacturer
    The Bloomi Inc..
    Date Cleared
    2022-08-04

    (90 days)

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

    The Bloomi Inc..

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Bloomi Smooth Water Based Personal Lubricant is a water-based personal lubricant for penile and/or vaginal application, intended to lubricate and moisturize, enhance the ease and comfort of intimate sexual activity and supplement the body's natural lubrication. This product is compatible with natural rubber latex and polyisoprene condoms. This product is not compatible with polyurethane condoms.
    Device Description
    The Bloomi Smooth Water Based Personal Lubricant is a non-sterile, water-based personal lubricant that is intended for penile and vaginal application 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 and polyisoprene condoms. This product is not compatible with polyurethane condoms. Its formulation consists of Water, Hydroxyethylcellulose, Microcare SB (water, sodium benzoate, potassium sorbate), Activsoft S (Cyamopsis Tetragonoloba (Guar) Gum), Citric Acid, Sodium Hyaluronate, Organic Sunflower Extract, Organic Green Tea Extract (Organic Camellia Sinensis Leaf (Green Tea) Extract). The Bloomi Smooth Water Based Personal Lubricant is packaged in a MDPE (medium density polyethylene) 3 oz tube, packaged in an outer box for OTC use.
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