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510(k) Data Aggregation

    K Number
    K200527
    Device Name
    pjur WOMAN Aloe, pjur analyse me! water-based, pjur BACK DOOR water-based, pjur med Moisturising glide,pjur med NATURAL glide, We-Vibe Lube made by pjur
    Manufacturer
    pjur group Luxembourg SA
    Date Cleared
    2021-02-19

    (354 days)

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

    pjur group Luxembourg SA

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    pjur® WOMAN Aloe is a personal lubricant for penile, vaginal and/or anal application, intended to moisturize and lubricate, enhance the ease and comfort of intimate sexual activity and supplement the body's natural lubrication. This product is compatible with natural rubber latex condoms. This product is not compatible with polyurethane and polyisoprene condoms. pjur® med Moisturising glide is a personal lubricant for penile, vaginal application, intended to moisturize and lubricate, enhance the ease and comfort of intimate sexual activity and supplement the body's natural lubrication. This product is compatible with natural rubber latex condoms. This product is not compatible with polyurethane and polyisoprene condoms. pjur® BACK DOOR water-based is a personal lubricant for penile, vaginal and/or anal application, intended to moisturize and lubricate, enhance the ease and comfort of intimate sexual activity and supplement the body's natural lubrication. This product is compatible with natural rubber latex condoms. This product is not compatible with polyurethane and polyisoprene condoms. pjur® analyse me! water-based is a personal lubricant for penile, vaginal and/or anal application, intended to moisturize and lubricate, enhance the ease and comfort of intimate sexual activity and supplement the body's natural lubrication. This product is compatible with natural rubber latex condoms. This product is not compatible with polyurethane and polyisoprene condoms. pjur® med NATURAL glide is a personal lubricant for penile, vaginal and/or anal application, intended to moisturize and lubricate, 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. We-Vibe® Lube made by pjur® is a personal lubricant for penile, vaginal and/or anal application, intended to moisturize and lubricate, 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 polvisoprene condoms. This product is not compatible with polyurethane condoms.
    Device Description
    The pjur® WOMAN Aloe, pjur® analyse me! water-based, pjur® BACK DOOR water-based, pjur® med Moisturising glide, pjur® med NATURAL glide, and We-Vibe® Lube made by pjur® are water-based personal lubricants provided non-sterile. These over-the-counter products have similar formulations and contain neither a contraceptive nor a spermicide. The pjur® analyse me! waterbased, pjur® BACK DOOR water-based, and pjur® med Moisturising glide are compatible with natural rubber latex condoms. They are not compatible with polyurethane and polyisoprene condoms. The pjur® med NATURAL glide, and We-Vibe® Lube made by pjur® are compatible with natural rubber latex and polyisoprene condoms. They are not compatible with polyurethane condoms. The pjur® WOMAN Aloe has a formulation that consists of water, glycerin, xanthan gum, benzyl alcohol, sodium benzoate, citric acid, potassium sorbate, aloe barbadensis leaf juice powder. This lubricant is provided in 30 ml, 100 ml, and 250 ml polyethylene bottles. The pjur® med NATURAL glide, and We-Vibe® Lube made by pjur® have the same formulation that includes the same components as the lubricant above, without aloe barbadensis leaf juice powder. The pjur® med NATURAL glide device is provided in 10 ml and 100 ml polyethylene bottles. We-Vibe® Lube made by pjur® is provided in 30 ml polyethylene bottles, and 125 ml polyethylene/polypropylene pump bottles. The pjur® analyse me! water-based, pjur® BACK DOOR water-based, and pjur® med Moisturising glide have the same formulation that consists of water, glycerin, xanthan gum, benzyl alcohol, sodium benzoate, potassium sorbate, citric acid, sodium hyaluronate. The pjur® analyse me! water-based is provided in 10 ml, 100ml, and 250 ml polyethylene bottles. pjur® BACK DOOR water-based is provided in 10 ml, 100 ml, and 250 ml polyethylene bottles. pjur® med Moisturising qlide is provided in 10 ml and 100 ml polyethylene bottles.
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    K Number
    K200731
    Device Name
    pjur AQUA Baseline, pjur AQUA Guarana, pjur AQUA ProVitamin B5, pjur BACK DOOR anal Provitamin B5
    Manufacturer
    pjur group Luxembourg SA
    Date Cleared
    2021-01-21

    (307 days)

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

    pjur group Luxembourg SA

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    pjur® AQUA Baseline for penile, vaginal and/or anal application, intended to moisturize and lubricate, 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, polyisoprene, and polyurethane condoms. pjur® AQUA Guarana for penile, vaginal and/or anal application, intended to moisturize and lubricate, 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, polyisoprene, and polyurethane condoms. pjur® BACK DOOR anal Provitamin B5 for penile, vaginal and/or anal application, intended to moisturize and lubricate, 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, polyisoprene, and polyurethane condoms. pjur® AQUA ProVitamin B5 for penile, vaginal and/or anal application, intended to moisturize and lubricate, 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, polyisoprene, and polyurethane condoms.
    Device Description
    The piur® AQUA Baseline, pjur® AQUA Guarana, pjur® BACK DOOR anal Provitamin B5, and pjur® AQUA ProVitamin B5 are water-based personal lubricants provided non-sterile. These personal lubricants are for over-the-counter use. They are not compatible with natural rubber latex, polyurethane, and polyisoprene condoms. The products are provided in 30 mL and 100 mL polyethylene bottles. The pjur® AQUA Baseline consists of water, glycerin, ethoxydiglycol, phenoxyethanol, hydroxypropyl guar hydroxypropyltrimonium chloride, hydroxyethylcellulose, and citric acid. The pjur® AQUA Guarana, pjur® BACK DOOR anal Provitamin B5, and pjur® AQUA ProVitamin B5 have the same formulation and consist of water, glycerin, ethoxydiglycol, phenoxyethanol, hydroxypropyltrimonium chloride, propylene glycol, hydroxyethylcellulose, panthenol, polysorbate 20, citric acid, chamomilla recrutita (matricaria) flower extract, paullinia cupana seed extract, cananga odorata flower oil, alcohol, 1,2hexanediol, decylene glycol, lactic acid, sodium benzoate, and potassium sorbate.
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    K Number
    K200730
    Device Name
    pjur WOMAN Nude pjur med SENSITIVE glide
    Manufacturer
    pjur group Luxembourg SA
    Date Cleared
    2020-12-17

    (272 days)

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

    pjur group Luxembourg SA

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    pjur® med SENSITIVE glide for penile, vaginal and/or anal application, intended to moisturize and lubricate, enhance the ease and comfort of intimate sexual activity and supplement the body's natural lubrication. This product is compatible with natural rubber latex condoms. This product is not compatible with polyurethane and polyisoprene condoms. pjur® WOMAN Nude for penile, vaginal and/or anal application, intended to moisturize and lubricate, enhance the ease and comfort of intimate sexual activity and supplement the body's natural lubrication. This product is compatible with natural rubber latex condoms. This product is not compatible with polyurethane and polyisoprene condoms.
    Device Description
    The pjur® med SENSITIVE glide and pjur® WOMAN Nude are water-based personal lubricants provided non-sterile. These over-the-counter products have an identical formulation and contain neither a contraceptive nor a spermicide. They are compatible with natural rubber latex condoms and are not compatible with polyurethane or polyisoprene condoms. The pjur® med SENSITIVE glide is provided in 100 mL polyethylene bottles and the pjur® WOMAN Nude is provided in either 10 mL or 100 mL polyethylene bottles. The pjur® med SENSITIVE glide and pjur® WOMAN Nude consists of water, 1,2 propylene glycol, ethyoxydiglycol, hydroxypropyl guar hydroxypropyltrimonium chloride, hydroxyethylcellulose, sodium saccharin, and citric acid.
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    K Number
    K141913
    Device Name
    PJUR SILICONE BASED LUBRICANT: PJUR BACKDOOR ANAL GLIDE AND ANALYSE ME!
    Manufacturer
    PJUR GROUP LUXEMBOURG SA
    Date Cleared
    2015-04-06

    (265 days)

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

    PJUR GROUP LUXEMBOURG SA

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    pjur® Backdoor Anal Glide and pjur® Analyse Me! are personal lubricants for penile, vaginal, and/or anal 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, synthetic polyisoprene, and polyurethane condoms.
    Device Description
    The pjur® Backdoor Anal Glide or pjur® Analyse Me! device is a non-sterile, silicone-based personal lubricant. This over-the-counter product is formulated to be clear, non-irritating, non-greasy, and odorless. The pjur® Backdoor Anal Glide or pjur® Analyse Me! Device is a silicone based lubricant contains neither a contraceptive nor a spermicide. The product contains Cyclopentasiloxane, Dimethicone, Dimethiconol, and jojoba.
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    K Number
    K133233
    Device Name
    PJUR ORIGINAL, PJUR WOMAN, PJUR MAN EXTREME GLIDE
    Manufacturer
    PJUR GROUP LUXEMBOURG SA
    Date Cleared
    2014-07-18

    (270 days)

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

    PJUR GROUP LUXEMBOURG SA

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    pjur® Original, pjur® Woman, and pjur® MAN Extreme Glide are personal lubricants, for penile and/or vaginal application, intended to moisturize and lubricate, enhance the ease and comfort of intimate sexual activity and supplement the body's natural lubrication. These products are compatible with natural rubber latex, polyurethane, and polyisoprene condoms.
    Device Description
    The pjur® Original, pjur® Woman, and pjur® MAN Extreme Glide lubricants are non-sterile, silicone-based personal lubricants. These over-the-counter products are formulated to be clear, non-irritating, non-greasy, and odorless. The pjur® silicone based lubricants contains neither a contraceptive nor a spermicide.
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