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510(k) Data Aggregation

    K Number
    K041667
    Device Name
    SAN-MAR LABS LUBRICATING JELLY
    Manufacturer
    SAN-MAR LABORATORIES, INC.
    Date Cleared
    2005-01-13

    (209 days)

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

    SAN-MAR LABORATORIES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Use Lubricating Jelly to lubricate condoms and for personal lubrication when vaginal dryness causes discomfort. It also eases insertion of rectal thermometers, enemas, and tampons.
    Device Description
    The device is a water-based personal lubricant containing chlorhexidine gluconate and methylparaben as preservatives in a vehicle for glucono delta lactone. glycerin, hydroxyethylcellulose, sodium hydroxide, and purified water.
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    K Number
    K983216
    Device Name
    CVS PERSONAL LUBRICANT
    Manufacturer
    SAN-MAR LABORATORIES, INC.
    Date Cleared
    1999-05-17

    (245 days)

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

    SAN-MAR LABORATORIES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Personal lubrication and lubrication of a body orifice to facilitate entry of a diagnostic or therapeutic device, as a moisturizer for vaginal dryness, and to enhance condom use and the ease of intimate activity.
    Device Description
    "CVS Personal Lubricant" is a clear , colorless and odorless personal lubricant, which is composed of the following ingredients; Purified Water, Glycerin, Propylene Glycol, Polyquaternium #5, Methyparaben and Propylparaben. The "CVS Personal Lubricant" bottle is composed of high density polyethylene plastic.
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