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510(k) Data Aggregation

    K Number
    K142473
    Device Name
    Lubricating Jelly
    Manufacturer
    SION BIOTEXT MEDICAL LTD
    Date Cleared
    2015-04-13

    (222 days)

    Product Code
    KMJ
    Regulation Number
    880.6375
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    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Lubricating Jelly is a medical device intended for medical purposes, to lubricate body orifices to facilitate entry of diagnostic or therapeutic devices when either sterile or non-sterile fields are required.
    Device Description
    Sion's Lubricating Jelly is used to lubricate body orifices to facilitate entry of diagnostic or therapeutic devices when either sterile or non-sterile fields are required. Typical uses of the lubricating jelly include (but not limited) insertion of catheters, endoscopes surgical instruments, gynecological, rectal, oral and rubber or plastic etc. The lubricating jelly is clear, greaseless, odorless, water soluble and non-irritating to the skin, tissue and mucous membranes. Both product types (sterile and non-sterile) are packed in a bacterial barrier tubes or sealed laminated sachets. Sion's Lubricating Jelly is a body contact material and was evaluated for biocompatibility with accordance to FDA's Memorandum - #G95 1, May 1, 1995 and ISO 10993-1:2009.
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    K Number
    K131617
    Device Name
    COLONGLIDE(R) LUBRICANT
    Manufacturer
    PEDIATRIC PHARMACEUTICALS, INC.
    Date Cleared
    2013-10-03

    (122 days)

    Product Code
    KMJ
    Regulation Number
    880.6375
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    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Colonglide® Lubricant Is indicated for medical purposes for use to lubricate a body orifice of a patient in order to facilitate the entry of a diagnostic or therapeutic medical device (such as an endoscope). This device is intended for use on order of a physician.
    Device Description
    Colonglide® Lubricant is a clear, colorless, non-sterile, odorless, water-based patient lubricant. The subject device is packaged for individual use in a 250 mL round plastic bottle sealed with a screw cap with a foil induction innerseal liner.
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    K Number
    K121390
    Device Name
    LUBE JELLY SURINGE
    Manufacturer
    NURSE ASSIST, INC.
    Date Cleared
    2012-08-10

    (93 days)

    Product Code
    KMJ
    Regulation Number
    880.6375
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    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    For Prescription Use: For easing the insertion of medical devices such as scopes and catheters into body orifices.
    Device Description
    The subject device is a terminally gamma sterilized 10cc polypropylene plastic syringe filled with United Guardian lubricating jel and capped with a polypropylene plastic cap. United Guardian has a Master File Reference for its lubrication jel, Master File for Devices MAF-613 pertaining to Lubrajel RR. All components of the device are gamma irradiation stable.
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    K Number
    K113689
    Device Name
    DUKAL LUBRICATING JELLY
    Manufacturer
    DUKAL CORPORATION
    Date Cleared
    2012-05-04

    (141 days)

    Product Code
    KMJ
    Regulation Number
    880.6375
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    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Dukal Sterile Lubricating Jelly is a medical device intended for medical purposes, to lubricate body orifices to facilitate entry of diagnostic devices when a sterile field is required.
    Device Description
    The Dukal Sterile Lubricating Jelly is a clear, greaseless, water soluble jelly.
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    K Number
    K112110
    Device Name
    STERILE LUBRICATING JELLY
    Manufacturer
    JIANERKANG MEDICAL DRESSING COMPANY
    Date Cleared
    2012-04-10

    (263 days)

    Product Code
    KMJ
    Regulation Number
    880.6375
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    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Jianerkang Sterile Lubricating Jelly is intended for medical purposes, to lubricate body orifices to facilitate entry of diagnostic or therapeutic devices when a sterile field is required.
    Device Description
    The Jianerkang Sterile Lubricating Jelly is a clear, greaseless, watersoluble sterile lubricating jelly.
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    K Number
    K101585
    Device Name
    K-Y BRAND LONG LASTING VAGINAL MOISTURIZER
    Manufacturer
    JOHNSON & JOHNSON CONSUMER & PERSONAL PRODUCTS WOR
    Date Cleared
    2011-05-10

    (337 days)

    Product Code
    NUC
    Regulation Number
    884.5300
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    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    K-Y® Brand Vaginal Moisturizer is a personal lubricant, for 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 or synthetic condoms.
    Device Description
    K-Y® Brand Vaginal Moisturizer is a non-sterile personal moisturizer formulated to supplement the body's own natural lubricating fluids to provide personal moisturization when vaginal dryness causes discomfort. K-Y® Brand Vaginal Moisturizer, is a stable, non-sterile, translucent, aqueous based, preserved, formulated product composed of a combination of emollients, gelling agents, preservatives, vehicles, and an antioxidant. It is non-fragranced, pH balanced, and contains Vitamin E. The proposed device is packaged in pre-filled applicators to facilitate insertion directly into the vagina.
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    K Number
    K103718
    Device Name
    DYNACOR LUBRICATION GEL
    Manufacturer
    MEDLINE INDUSTRIES, INC.
    Date Cleared
    2011-05-10

    (140 days)

    Product Code
    KMJ
    Regulation Number
    880.6375
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    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The gel is intended to be used to lubricate a body orifice to facilitate entry of a diagnostic or therapeutic device.
    Device Description
    Not Found
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    K Number
    K101522
    Device Name
    ULTRA SEAL STERILE LUBRICATING JELLY
    Manufacturer
    ULTRA SEAL CORPORATION
    Date Cleared
    2010-12-23

    (204 days)

    Product Code
    KMJ
    Regulation Number
    880.6375
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    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    For lubrication to provide easy insertion of catheters, endoscopes, or gloved fingers into bodily orifices. The device is intended for use on order of a physician. Non-prescription over-the-counter use.
    Device Description
    Ultra Seal Sterile Lubricating Jelly patient lubricant is a water- based, clear, colorless, non-sticky, non-greasy, non-staining, nonirritating patient lubricant. It is a water soluble, high viscosity gel-like liquid for use as patient lubricant when a sterile field is required. Each tube or packet is terminally sterilized by gamma radiation. The product is sterile unless package is opened, damaged, or the seal for the packet product is not intact, with label directions to discard after use. The product is packaged in a convenient 2 oz., 4.0 oz., and 4.2 oz aluminum tube with a cap and a puncture seal blind, or a 2 oz., 4.0 oz., and 4.2 oz foil laminate tube with a flip top and a peel seal, and 3 and 5 gram laminated film packets, the lamination being paper, polyethylene, foil, polyethylene. All tube configurations contain an aluminum barrier to preserve the product's properties and sterility. Stability has been performed on all tubes and packets and data from 3 months of accelerated studies supports an initial expiration term of 24 months from the date of manufacture. Expiration dating will be confirmed through concurrent room temperature stability studies. This product is not a contraceptive and does not contain a spermicide.
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    K Number
    K092488
    Device Name
    DYNAREX STERILE LUBRICATING JELLY
    Manufacturer
    DYNAREX CORPORATION
    Date Cleared
    2009-12-18

    (127 days)

    Product Code
    KMJ
    Regulation Number
    880.6375
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    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Dynarex Sterile Lubricating Jelly is a medical device intended for medical purposes, to lubricate body orifices to facilitate entry of diagnostic or therapeutic devices when a sterile field is required.
    Device Description
    Dynarex Sterile Lubricating Jelly is a clear, greaseless, water soluble jelly. Typical packaging configurations for the Dynarex Sterile Lubricating Jelly is 3 g or 5 g foil packs, and 2 oz or 4 oz tubes, Other sizes may become available.
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    K Number
    K090457
    Device Name
    ORALUBE
    Manufacturer
    PULPDENT CORPORATION
    Date Cleared
    2009-05-21

    (87 days)

    Product Code
    ONK
    Regulation Number
    880.6375
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    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    OraLube is a water-soluble, viscous liquid coating intended to be used an intraoral and perioral release agent for the following clinical situations: - Taking an impression, in which OraLube is placed on the gums and inside the lip (areas not critical to the final outcome of the prosthesis) to facilitate the release of impression material and is applied to the lips and the skin around the mouth to prevent adherence of impression material; - Using a dental cement or adhesive, in which OraLube is applied to adjacent hard and soft tissue and to the lips and skin around the mouth to prevent adherence of the cement or adhesive; - Placement of a rubber dam, in which OraLube is brushed on the tooth to facilitate slipping the rubber dam over it. - Long procedures, in which OraLube can be used to protect the lips from drying out and cracking.
    Device Description
    Pulpdent OraLube is a water-soluble, viscous liquid coating intended to be used as an intraoral and perioral release agent, slip agent, lubricant, lip and skin protector.
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