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510(k) Data Aggregation

    K Number
    K081040
    Device Name
    POWDERED LATEX EXAMINATION GLOVES, SMALL, MEDIUM, LARGE, X-LARGE
    Date Cleared
    2008-05-20

    (39 days)

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

    PT. SHAMROCK MANUFACTURING CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    A palient examination glove is a disposable device intended for medical purpose that is worn on examiner's hand to prevent contamination between patient and examiner.
    Device Description
    Powdered Latex Examination Gloves
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    K Number
    K052709
    Device Name
    POWDER FREE LATEX EXAMINATION GLOVES, SIZES SMALL, MEDIUM, LARGE, X-LARGE
    Date Cleared
    2005-11-08

    (40 days)

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

    PT. SHAMROCK MANUFACTURING CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    A patient examination glove is a disposable device intended for medical purpose that is worn on examiner's hand to prevent contamination between patient and examiner.
    Device Description
    Powder free Latex Examination Gloves
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    K Number
    K052382
    Device Name
    POWDER FREE NITRILE EXAMINATION GLOVES, BLUE
    Date Cleared
    2005-09-15

    (16 days)

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

    PT. SHAMROCK MANUFACTURING CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    A patient examination glove is a disposable device intended for medical purpose that is worn on examiner's hand to prevent contamination between patient and examiner.
    Device Description
    Powder Free Nitrile Examination Gloves, Blue
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    K Number
    K030325
    Device Name
    POWDERFREE LATEX EXAMINATION GLOVES WITH BUBBLEGUM
    Date Cleared
    2003-03-28

    (56 days)

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

    PT. SHAMROCK MANUFACTURING CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Powder free Latex Examination Gloves with Bubblegum Aroma is a disposable device intended for medical purpose that is worn on examiner's hand to prevent contamination between patient and examiner.
    Device Description
    Powder free Latex Examination Gloves with Bubblegum Aroma
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    K Number
    K030134
    Device Name
    LATEX EXAMINATION GLOVES POWDER FREE WITH NEOPRENE LINED, SIZES XSMALL, SMALL, MEDIUM, LARGE, XLARGE
    Date Cleared
    2003-03-25

    (70 days)

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

    PT. SHAMROCK MANUFACTURING CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Latex Examination Glove Powder Free with Neoprene lined is a disposable device intended for medical purpose that is worn on examiner's hand to prevent contamination between patient and examiner.
    Device Description
    Latex Examination Gloves Powder Free With Lined.
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    K Number
    K030560
    Device Name
    POWDERFREE LATEX EXAMINATION GLOVES WITH GRAPE
    Date Cleared
    2003-03-21

    (28 days)

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

    PT. SHAMROCK MANUFACTURING CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Powder free Latex Examination Gloves with Grape is disposable device intended for medical purpose that is worn on examiner's hand to prevent contamination between patient and examiner.
    Device Description
    Powder free Latex Examination Gloves with Grape is disposable device intended for medical purpose that is worn on examiner's hand to prevent contamination between patient and examiner.
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    K Number
    K011712
    Device Name
    LATEX EXAMINATION GLOVES- POWDER FREE, BLUE
    Date Cleared
    2001-07-17

    (43 days)

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

    PT. SHAMROCK MANUFACTURING CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    A powder free examination glove is a disposable device intended for medical purpose that is worn on examiner's hand to prevent contamination on examiner's hand: to prevent of ・・・・・・・・・・・・・・・ ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ー …… ' Powder free Latex Examination Glove is a disposable device intended for medical purpose that is worn on examiner's hand to prevent contamination between patient and examiner.
    Device Description
    Powder Free - Latex Examination Gloves
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