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510(k) Data Aggregation

    K Number
    K221036
    Device Name
    Astroglide Warming
    Manufacturer
    BioFilm Inc.
    Date Cleared
    2022-07-01

    (85 days)

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

    BioFilm Inc

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Astroglide Warming is a personal lubricant 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. This product is compatible with natural rubber latex and polyisoprene condoms. This product is not compatible with polyurethane condoms.
    Device Description
    Astroglide Warming is non-sterile, clear and water based personal lubricant. This product is not a spermicide or contraceptive. It is compatible with natural rubber latex and polyisoprene condoms only. It is not compatible with polyurethane condoms. The device is composed of water, glycerin, propylene glycol, polyquaternium-7 and citric acid.
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    K Number
    K220355
    Device Name
    Astroglide Ultra Gentle Gel
    Manufacturer
    BioFilm Inc.
    Date Cleared
    2022-05-26

    (107 days)

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

    BioFilm Inc

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Astroglide Ultra Gentle Gel is a personal lubricant 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. This product is compatible with natural rubber latex and polyisoprene condoms. This product is not compatible with polyurethane condoms.
    Device Description
    Astroglide Ultra Gentle Gel is a non-sterile, clear, odorless, and water based personal lubricant. This product is not a spermicide or contraceptive. It is compatible with natural rubber latex and polyisoprene condoms. This product is not compatible with polyurethane condoms. The device is composed of water, propylene glycol, hydroxyethylcellulose, polyquaternium 7, potassium sorbate, sodium benzoate and citric acid. The product primary packaging is a white LDPE 3-ounce tube with a screw on cap. The tube and cap constitute the device final packaging.
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    K Number
    K220653
    Device Name
    Astroglide Glycerin & Paraben Free
    Manufacturer
    BioFilm Inc.
    Date Cleared
    2022-05-06

    (60 days)

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

    BioFilm Inc

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Astroglide® Glycerin & Paraben Free is a personal lubricant for penile, 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. This product is compatible with natural rubber latex and polyisoprene condoms. This product is not compatible with polyurethane condoms.
    Device Description
    Astroglide® Glycerin & Paraben Free is a non-sterile, water-based liquid personal lubricant for penile, anal, and/or vaginal application. This product is not a spermicide or contraceptive. It is compatible with natural rubber latex and polyisoprene condoms. It is not compatible with polyurethane condoms. The subject device is sold as an overthe-counter (OTC) product in a 2.5 oz. clear PETE bottle with a screw on polypropylene flip-top cap. The bottle is labeled front and back and then packaged in a cardboard carton which constitutes the final packaging. This device is composed of water, butylene glycol, propylene glycol, xylitol, methyl gluceth-20, polyquarternium-7, hydroxyethyl cellulose, potassium sorbate, sodium benzoate, citric acid.
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    K Number
    K213671
    Device Name
    Astroglide Sensual Strawberry Personal Lubricant
    Manufacturer
    BioFilm Inc.
    Date Cleared
    2022-03-03

    (101 days)

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

    BioFilm Inc

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Astroglide® Sensual Strawberry Personal Lubricant is a personal lubricant 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. This product is compatible with natural rubber latex condoms. This product is not compatible with polyisoprene or polyurethane condoms.
    Device Description
    Astroglide® Sensual Strawberry Personal Lubricant is a non-sterile, clear, strawberry-scented and flavored, water-based personal lubricant intended for penile, anal, or vaginal application. This product is not a spermicide or contraceptive. Astroglide® Sensual Strawberry Personal Lubricant is compatible with natural rubber latex condoms. It is not compatible with polyisoprene and polyurethane condoms. This product's primary packaging is a PETE clear bottle with a screw on polypropylene flip-top cap. The bottle is then packaged in a cardboard carton which constitutes the final packaging.
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    K Number
    K210242
    Device Name
    Astroglide X Silicone Personal Lubricant
    Manufacturer
    BioFilm Inc.
    Date Cleared
    2021-04-28

    (89 days)

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

    BioFilm Inc

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Astroglide® X Silicone Personal Lubricant is a personal lubricant 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. This product is compatible with natural rubber latex condoms. This product is not compatible with polyisoprene and polyurethane condoms.
    Device Description
    Astroglide® X Silicone Personal Lubricant is non-sterile, clear, odorless, and siliconebased lubricant. This product is not a spermicide or contraceptive. Astroglide® X Silicone Personal Lubricant is compatible with natural rubber latex condoms. Astroglide® X Silicone Personal Lubricant is not compatible with polyurethane, or polyisoprene condoms. This product's primary packaging is a PETE clear bottle with a screw on polypropylene flip-top cap. The bottle is packaged in a cardboard carton which constitutes the final packaging.
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    K Number
    K200239
    Device Name
    Astroglide Organix Gel
    Manufacturer
    BioFilm Inc.
    Date Cleared
    2020-11-13

    (287 days)

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

    BioFilm Inc

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Astroglide® Organix® Gel is a personal lubricant 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. This product is compatible with natural rubber latex and polyisoprene condoms. The product is not compatible with polyurethane condoms.
    Device Description
    Astroglide® Organix ® Gel is non-sterile, translucent, colorless to slight yellow, water-based personal lubricant 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 and is not compatible with polyurethane condoms. This product is for over-the-counter (OTC) use. Astroglide® Organix ® Gel's formulation consists of water, glycerine, xanthan gum, gellan gum, aloe barbabensis powder, chamomilla recutita (matricaria) flower extract, calendula officinalis flower extract, vaccinium macrocarpon (cranberry) fruit extract, passiflora incarnata flower extract, sodium benzoate, potassium sorbate, and citric acid. It is packaged in white LDPE tube with a screw on flip top cap comprised of polypropylene. This product is also provided in 2.5 ml foil packs.
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    K Number
    K200114
    Device Name
    Astroglide Organix Liquid
    Manufacturer
    BioFilm Inc
    Date Cleared
    2020-10-13

    (266 days)

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

    BioFilm Inc

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Astroglide® Organix® Liquid is a personal lubricant 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. This product is compatible with natural rubber latex and polyisoprene condoms. This product is not compatible with polyurethane condoms.
    Device Description
    Astroglide® Organix® Liquid is a non-sterile, colorless to slight yellow, water-based personal lubricant 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 and is not compatible with polyurethane condoms. This product is for over-the-counter (OTC) use. Astroglide® Organix® Liquid's formulation consists of water, glycerin, xanthan gum, aloe barbabensis powder, chamomilla recutita (matricaria) flower extract, calendula officinalis flower extract, vaccinium macrocarpon (cranberry) fruit extract, passiflora incarnata flower extract, sodium benzoate, potassium sorbate, and citric acid. It is packaged in 2.5 oz polyethylene terephthalate bottles with a polypropylene flip-top cap. Bottles are secondarily packaged in cardboard cartons. This product is also provided in 2.5 ml foil packs.
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    K Number
    K171985
    Device Name
    Astroglide O Oil Personal Lubricant & Massage Oil
    Manufacturer
    BioFilm Inc.
    Date Cleared
    2017-08-30

    (58 days)

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

    BioFilm Inc

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Astroglide® O Oil Personal Lubricant & Massage Oil is a personal lubricant 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. This product is not compatible with condoms.
    Device Description
    Astroglide® O Oil Personal Lubricant & Massage Oil is non-sterile, light yellow, lightly coconut and ylang-ylang scented, and oil-based lubricant. All oils used in the subject formulation are certified organic, and the subject lubricant is a USDA certified organic final product. This product is not a spermicide or contraceptive. It is NOT compatible with natural rubber latex, polyurethane, or polyisoprene condoms. This product primary packaging is a PETE amber bottle with a screw on polypropylene flip-top cap. The bottle and cap constitute the device are labeled front and back and then packaged in a cardboard carton which constitutes the final packaging.
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