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510(k) Data Aggregation

    K Number
    K221829
    Device Name
    Wet Flavored Personal Lubricants
    Manufacturer
    Trigg Laboratories, Inc.
    Date Cleared
    2022-09-23

    (92 days)

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

    Trigg Laboratories, Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Wet Flavored Personal Lubricants are personal lubricants 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. The product is compatible with natural rubber latex and polyisoprene condoms. The product is not compatible with polyurethane condoms.
    Device Description
    The Wet Flavored Personal Lubricants are clear, non-sterile, over-the-counter personal lubricants, formulated to be clear, particle-free, and colorless to slight yellow. The device is designed to supplement the body's own natural lubrication fluids during intimate sexual activity. The product is compatible with natural rubber latex and polyisoprene condoms. The product is not compatible with polyurethane condoms. The device formula is neither a contraceptive nor a spermicide.
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    K Number
    K220534
    Device Name
    Wet Essential95 Personal Lubricant
    Manufacturer
    Trigg Laboratories, Inc.
    Date Cleared
    2022-07-07

    (133 days)

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

    Trigg Laboratories, Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Wet Essential95 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
    The Wet Essential95 Personal Lubricant is a non-sterile, 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 device is compatible with natural rubber latex and polyisoprene condoms and is not compatible with polyurethane condoms. Its formulation consists primarily of 95% aloe barbadensis leaf juice. Wet Essential95 Personal Lubricant is sold as an over-the-counter (OTC) product and is provided in 4 oz and 6 oz HDPE bottles.
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    K Number
    K191480
    Device Name
    Wet Water Based Personal Lubricant (additionally, branded as WET Platinum Houston, Elite Water-Based Hybrid)
    Manufacturer
    Trigg Laboratories, Inc. D/B/A Wet International
    Date Cleared
    2019-10-11

    (129 days)

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

    Trigg Laboratories, Inc. D/B/A Wet International

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Wet Water Based Personal Lubricant (additionally, branded as WET Platinum Houston, Elite Water-Based Hybrid) is a personal lubricant for penile, anal 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
    The Wet Water Based Personal Lubricant is a non-sterile, water and silicone blend personal lubricant that provides lubrication during intimate sexual activity. This device is compatible with natural rubber latex and polyisoprene condoms, and is not compatible with polyurethane condoms. The Wet Water Based Personal Lubricant is provided in 3 oz.high density polyethylene terephthalate bottle is fitted with dispensing bottle cap with a disc-top. Wet Water Based Personal Lubricant is a personal lubricant for over-the-counter (OTC) use.
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    K Number
    K130012
    Device Name
    WET PLATINUM PERSONAL LUBRICANT
    Manufacturer
    TRIGG LABORATORIES, INC.
    Date Cleared
    2013-08-22

    (232 days)

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

    TRIGG LABORATORIES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Trigg Laboratories Wet Platinum Premium Lubricant® 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, polyisoprene, and polyurethane condoms.
    Device Description
    The Wet Platinum Premium Lubricant® is a non-sterile, silicone based personal lubricant, an over-the-counter personal lubricant, formulated to be clear, non-irritating, non-greasy natural and odorless. It is a Silicone soluble, gel-like liquid for use as a personal lubricant. The Wet Platinum Premium Lubricant® contains a blend of silicone fluid ingredients similar to ingredients found in the predicate device. The specifications for Wet Platinum include appearance, odor, viscosity, specific gravity, total aerobic microbial count, total yeast and mold count, absence of pathogenic organisms (Pseudomonas aeruginosa, Staphylococcus aureus, Candida albicans, Escherichia coli, Salmonella, and Clostrida), and antimicrobial effectiveness. Osmolality and pH are not applicable specifications because the subject lubricant is anhydrous.
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    K Number
    K013086
    Device Name
    WET LIGHT PERSONAL MOISTURIZER
    Manufacturer
    TRIGG LABORATORIES, INC.
    Date Cleared
    2001-12-13

    (90 days)

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

    TRIGG LABORATORIES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    WET® Light Personal Moisturizer is intended for which Bight refections. It is used to supplement over the counter abouther aginal area to enhance personal morscure in the vaguer used for lubricating sexual preasure. There easy insertion of rectal thermometers, tampons, douche and enema nozzles.
    Device Description
    Not Found
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