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510(k) Data Aggregation

    K Number
    K052728
    Device Name
    POWDER FREE LATEX STERILE PATIENT EXAMINATION GLOVES
    Manufacturer
    M/S. KANAM LATEX INDUSTRIES PVT. LTD.
    Date Cleared
    2005-12-05

    (67 days)

    Product Code
    LYY
    Regulation Number
    880.6250
    Why did this record match?
    Applicant Name (Manufacturer) :

    KANAM LATEX INDUSTRIES PVT. LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    A Powder Free Patient Examination Glove is a Disposable Device made of Natural Rubber -Latex and is intended to be worn on the hands, for medical purposes to provide a barrier against potentially infectious materials and other contaminants.
    Device Description
    A Powder Free Patient Examination Glove is a Disposable Device made of Natural Rubber -Latex and is intended to be worn on the hands, for medical purposes to provide a barrier against potentially infectious materials and other contaminants.
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    K Number
    K052214
    Device Name
    PRE-POWDERED STERILE EXAM GLOVES
    Manufacturer
    KANAM LATEX INDUSTRIES PVT. LTD.
    Date Cleared
    2005-09-13

    (29 days)

    Product Code
    LYY
    Regulation Number
    880.6250
    Why did this record match?
    Applicant Name (Manufacturer) :

    KANAM LATEX INDUSTRIES PVT. LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    A Powdered Patient Examination Glove is a Disposable Device made of Natural Rubber Latex and is intended to be worn on the hands, for medical purposes to provide a barrier against potentially infectious materials and other contaminants.
    Device Description
    PRE-POWDERED LATEX STERILE PATIENT EXAMINATION GLOVES
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    K Number
    K033564
    Device Name
    POWDER FREE LATEX SURGEONS GLOVES POLYMER COATED STERILE WITH OPTIONAL LABELING CLAIM OF E.P. LESS THAN 50 UG/DM2
    Manufacturer
    KANAM LATEX INDUSTRIES PVT. LTD.
    Date Cleared
    2004-02-24

    (104 days)

    Product Code
    KGO
    Regulation Number
    878.4460
    Why did this record match?
    Applicant Name (Manufacturer) :

    KANAM LATEX INDUSTRIES PVT. LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Polymer coated, Powderfree Sterile Surgeon's Glove is to be worn by Operating Room Personnel to protect a Surgical Would from contamination.
    Device Description
    POWDERFREE LATEX SURGEON'S GLOVES POLYMER COATED STERILE Contains 50 micrograms or less of Total water extractable protein per gram
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    K Number
    K013914
    Device Name
    POWDERFREE LATEX SURGEON'S GLOVES
    Manufacturer
    KANAM LATEX INDUSTRIES PVT. LTD.
    Date Cleared
    2002-02-06

    (71 days)

    Product Code
    KGO
    Regulation Number
    878.4460
    Why did this record match?
    Applicant Name (Manufacturer) :

    KANAM LATEX INDUSTRIES PVT. LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    A Powder - free surgeon's glove is a disposable device made of natural latex that may bear a trace amount of glove powder but not more than 2 milligrams per glove may bour a trace anounces on the hands, usually in surgical settings, to provide a barrier against potentially infectious materials and other contamination.
    Device Description
    Powder Free Latex Surgeon's Gloves with Protein Contact Labeling Claim (50 Micrograms or Less)
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