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510(k) Data Aggregation

    K Number
    K234099
    Device Name
    Select Hybrid Personal Lubricant, and Select Pure Silicone Personal Lubricant
    Manufacturer
    Select Labs, LLC
    Date Cleared
    2024-06-07

    (164 days)

    Product Code
    NUC
    Regulation Number
    884.5300
    Type
    Traditional
    Panel
    Obstetrics/Gynecology
    Reference & Predicate Devices
    K191480,K212260
    Why did this record match?
    Applicant Name (Manufacturer) :

    Select Labs, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    Select Hybrid 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 natural rubber latex, polyurethane, and polyisoprene condoms.

    Select Pure Silicone Personal 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 not compatible with natural rubber latex, polyurethane, and polyisoprene condoms.

    Device Description

    The Select Hybrid Personal Lubricant and Select Pure Silicone Personal Lubricant are nonsterile, over the counter, personal lubricants. These devices are 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. Both lubricants are not compatible with natural rubber latex, polyisoprene, and polyurethane condoms. These lubricants are neither a contraceptive nor a spermicide.

    The Select Hybrid Personal Lubricant formulation consists of distilled water, cyclopentasiloxane, dimethicone, dimethiconol, methylparaben, Cellosize™ hydroxyethyl cellulose PEG-10, and propylene glycol. The Select Pure Silicone Personal Lubricant formulation consists of cyclopentasiloxane, dimethicone, and dimethiconol.

    Both subject devices are packaged in high density polyethylene bottles (2oz., 40z., 80z., 160z., 32 oz., 64oz., and 128 oz.) with low density polyethylene caps or polypropylene/polyethylene/stainless steel combination pumps. The bottle closure/pumps are covered with a heat shrink polyethylene terephthalate glycol sleeve film.

    AI/ML Overview

    This document describes the 510(k) premarket notification for two personal lubricants, "Select Hybrid Personal Lubricant" and "Select Pure Silicone Personal Lubricant," by Select Labs, LLC. This is not a study about an AI/ML powered device, therefore the request can't be fulfilled.

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