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510(k) Data Aggregation

    K Number
    K123731
    Device Name
    BIOTENE ORAL BALANCE GEL, BIOTENE DRY MOUTH ORAL RINSE, BIOTENE MOISTURIZING MOUTH SPRAY
    Date Cleared
    2013-01-04

    (30 days)

    Product Code
    Regulation Number
    N/A
    Why did this record match?
    Applicant Name (Manufacturer) :

    GLAXOSMITHKLINE CONSUMER HEALTHCARE (GSKCH)

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The biotene Oral Balance Gel, biotene Dry Mouth Oral Rinse and biotene Moisturizing Mouth Spray intended use is to relieve the symptoms of dry mouth, refresh, moisturize, clean, soothe oral irritation and lubricate oral dryness.
    Device Description
    Not Found
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    K Number
    K103745
    Device Name
    BIOTENE MOISTURIZING MOUTH SPRAY FOR DRY MOUTH SYMPTOM RELIEF
    Date Cleared
    2011-07-20

    (209 days)

    Product Code
    Regulation Number
    N/A
    Why did this record match?
    Applicant Name (Manufacturer) :

    GLAXOSMITHKLINE CONSUMER HEALTHCARE (GSKCH)

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Relieves and treats the symptoms of dry mouth; refreshes mouth odors, soothes oral irritations, moisturizes, lubricates, and diminishes dry discomfort. Indication for Use: Relieves the symptoms of dry mouth; refreshes, moisturizes, soothes oral irritation, and lubricates oral dryness.
    Device Description
    Biotène Moisturizing Mouth Spray for Dry Mouth Symptom Relief is a specially formulated artificial saliva substitute which contains moisturizers, humectants, a protein, and patented salivary enzymes that collectively have lubricating, moisturizing, soothing, and refreshing properties to relieve & treat the symptoms of Dry Mouth. The spray is supplied in a 1.5 oz. non-pressurized pump action spray bottle fitted with cap.
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    K Number
    K101477
    Device Name
    BIOTENE DRY MOUTH MOUTHWASH, BIOTENE PBF DRY MOUTH MOUTHWASH
    Date Cleared
    2010-09-28

    (123 days)

    Product Code
    Regulation Number
    N/A
    Why did this record match?
    Applicant Name (Manufacturer) :

    GLAXOSMITHKLINE CONSUMER HEALTHCARE (GSKCH)

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Relieves the symptoms of dry mouth; refreshes, moisturizes, cleans, soothes oral irritation, and lubricates oral dryness.
    Device Description
    Biotène Dry Mouth Oral Rinse is a specially formulated artificial saliva substitute which contain moisturizers, humectants, a protein, and patented salivary enzymes, that collectively have lubricating, moisturizing, soothing, and refreshing properties to relieve & treat the symptoms of Dry Mouth. The liquid products are supplied in PET bottles of various sizes, including an 8 oz., 16 oz., and 33.8 oz., and also 15 ml. multilayer laminated foil pouches.
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    K Number
    K093189
    Device Name
    ACTIPROTECT UC N95 RESPIRATOR
    Date Cleared
    2010-07-02

    (266 days)

    Product Code
    Regulation Number
    880.6260
    Why did this record match?
    Applicant Name (Manufacturer) :

    GLAXOSMITHKLINE CONSUMER HEALTHCARE

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Actiprotect™ UC N95 Respirator is a single use, disposable respirator coated with Virucoat™ on the outer layer (active ingredient: citric acid, 1.8%, a pH lowering agent) and is not an antiviral drug. Actiprotect kills (inactivates) 99.99% of Influenza A viruses (tested against Influenza A subtypes H1N1 (including 2009 pandemic strain)) within one minute of contact with the surface of the respirator. In vitro (laboratory) tests have demonstrated 99.99% kill (inactivation) on the surface of the outer laver of the respirator when tested in vitro against the following influenza A viruses (tested against Influenza A subtypes (and strains): H1N1(JPN/35/2007, JPN/36/2007, including 2009 pandemic strain: NYMC X-179A), H2N2 (A2/JP/305/57), H3N2 (Hong Kong 8/68, JPN/12/2007) and including bird flu subtypes: H5N1 (VNH5N1-PR8/CDCRG), H5N9 (Turkey A/Wisc/68, Myna A/Mass/71), and Influenza B strains (JPN/85/2007, JPN/128/2007, JPN/143/2007)) under tested contact conditions. No clinical studies have been conducted comparing the ability of an uncoated N95 respirator and this coated N95 respirator to protect the wearer from influenza infection. Actiprotect™ is intended for use by the general public in public health medical emergencies. Effectiveness tested against specific Influenza A and Influenza A pandemic strains. It is intended to cover the nose and mouth of the wearer to help reduce wearer exposure to pathogenic biological airborne particulates. Actiprotect™ UC N95 Respirator also helps to protect the wearer from splash and spray of body fluids.
    Device Description
    Actiprotect™ UC N95 Respirator is a double strap, flat-fold style filtering facepiece respirator. It consists of multiple layers of non-woven fabric. A filtration layer provides a barrier to particles of various sizes through mechanical entrapment in a tortuous pathway and by surface attraction by electrostatic forces. The outer layer contains a coating to capture and inactivate viruses. The layers of non-woven fabric are ultrasonically sealed together at the outer perimeter. Two synthetic elastic straps are stapled or welded to the edge of the respirator and are used to secure the respirator to the user's face.
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    K Number
    K093161
    Device Name
    ACTIPROTECT UF N95 RESPIRATOR
    Date Cleared
    2010-05-10

    (216 days)

    Product Code
    Regulation Number
    878.4040
    Why did this record match?
    Applicant Name (Manufacturer) :

    GLAXOSMITHKLINE CONSUMER HEALTHCARE

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Actiprotect™ UF N95 Respirator is a single use, disposable respirator coated with Virucoat™ on the outer layer (active ingredient: citric acid, 1.8%, a pH lowering agent) and is not an antiviral drug. Actiprotect kills (inactivates) 99.99% of influenza A viruses (tested against influenza A subtypes H1N1 (including 2009 pandemic strain)) within one minute of contact with the surface of the respirator. In vitro (laboratory) tests have demonstrated 99.99% kill (inactivation) on the surface of the outer layer of the respirator when tested in vitro against the following influenza viruses (tested against Influenza A subtypes (and strains): H1N1(JPN/35/2007, JPN/36/2007, including 2009 pandemic strain: NYMC X-179A), H2N2 (A2/JP/305/57), H3N2 (Hong Kong 8/68, JPN/12/2007) and including bird flu subtypes: H5N1 (VNH5N1-PR8/CDCRG), H5N9 (Turkey A/Wisc/68, Myna A/Mass/71), and Influenza B strains (JPN/85/2007, JPN/128/2007, JPN/143/2007) ) under tested contact conditions. No clinical studies have been conducted comparing the ability of an uncoated N95 respirator and this coated N95 respirator to protect the wearer from influenza infection. Actiprotect™ is intended for occupational use during seasonal influenza A or an influenza A pandemic. It is intended to cover the nose and mouth of the wearer to help reduce wearer exposure to pathogenic biological airborne particulates during seasonal influenza A or an influenza A pandemic. Actiprotect™ UF N95 Respirator also helps to protect the wearer from splash and spray of body fluids.
    Device Description
    Actiprotect™ UF N95 Respirator is a double strap, flat-fold style filtering facepiece respirator. It consists of multiple layers of non-woven fabric. A filtration layer provides a barrier to particles of various sizes through mechanical entrapment in a tortuous pathway and by surface attraction by electrostatic forces. The outer layer contains a coating to capture and inactivate viruses. The layers of non-woven fabric are ultrasonically sealed together at the outer perimeter. Two synthetic elastic strips are stapled or welded to the edge of the respirator and are used to secure the mask to the user's face.
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    K Number
    K081923
    Device Name
    ACTIPROTECT UF N95 RESPIRATOR, DOUBLE STRAP, FLAT FOLD
    Date Cleared
    2009-07-01

    (359 days)

    Product Code
    Regulation Number
    878.4040
    Why did this record match?
    Applicant Name (Manufacturer) :

    GLAXOSMITHKLINE CONSUMER HEALTHCARE

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Actiprotect™ UF N95 Respirator is a single use, disposable respirator coated with Virucoat™ on the outer layer (active ingredient: citric acid, 1.8%, a pH lowering agent) and is not an antiviral drug. Actiprotect kills (inactivates) 99.99% of influenza A viruses (tested against influenza A subtypes H1N1 (2009 pandemic strains not tested)) within one minute of contact with the surface of the respirator. In vitro testing has demonstrated 99.99% kill (inactivation) on the surface of the outer layer when tested in vitro against the following influenza viruses (tested against Influenza A subtypes (and strains): H1N1(JPN/35/2007, JPN/36/2007, 2009 pandemic strains not tested), H2N2 (A2JJP/305/57), H3N2 (Hong Kong 8/68) and including bird flu subtypes: H5N1 (VNH5N1-PR8/CDCRG), H5N9 (Turkey A/Wisc/68, Myna A/Mass/71), and an Influenza B strain (JPN/85/2007)) under tested contact conditions. Correlation between in vitro activity and any clinical event has not been tested. Actiprotect™ is intended for occupational use during seasonal influenza A or an influenza A pandemic. It is intended to cover the nose and mouth of the wearer to help reduce wearer exposure to pathogenic biological airborne particulates during seasonal influenza A or an influenza A pandemic. Actiprotect™ UF N95 Respirator also helps to protect the wearer from splash and spray of body fluids.
    Device Description
    Actiprotect™ UF N95 Respirator is a double strap, flat-fold style filtering facepiece respirator. It consists of multiple layers of non-woven fabric. A filtration layer provides a barrier to particles of various sizes through mechanical entrapment in a tortuous pathway and by surface attraction by electrostatic forces. The outer layer contains a coating to capture and inactivate viruses. The layers of non-woven fabric are ultrasonically sealed together at the outer perimeter. Two synthetic clastic strips are stapled or welded to the edge of the respirator and are used to secure the mask to the user's face.
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    K Number
    K041563
    Device Name
    OASIS DRY MOUTH RELIEF DISCS OR OASIS MOUTH MOISTURIZING DISCS
    Date Cleared
    2004-08-27

    (78 days)

    Product Code
    Regulation Number
    N/A
    Why did this record match?
    Applicant Name (Manufacturer) :

    GLAXOSMITHKLINE CONSUMER HEALTHCARE, L

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Under the supervision of a healthcare professional, OASIS® dry mouth relief discs have been formulated for the relief of chronic and temporary xerostomia (dry mouth), which may be a result of disease such as Sjogren's Syndrome, oral inflammation, medication, chemo or radiotherapy, stess or aging. OTC labeling stipulates that OASIS® mouth moisturizing discs have been specially formulated for the relief of dry mouth symptoms such as difficulties in swallowing, speech, and changes in taste. These symptoms may be brought on by disease, stress, aging or medication.
    Device Description
    OASIS® is a disc that is allowed to dissolve slowly in the mouth. The product contains a lubricating polymer, with other ingredients to produce a pleasant flavored disc. The discs are presented in containers of various counts.
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