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510(k) Data Aggregation

    K Number
    K993454
    Device Name
    POWDERFREE LATEX EXAMINATION GLOVES (POLYMER COATED) (PROTEIN LABEL CLAIM - 50 MICROGRAMS OR LESS)
    Date Cleared
    1999-12-03

    (51 days)

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

    SRI JOHANI SDN. BHD.

    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 the examiner's hand or finger to prevent contamination between patient and examiner.
    Device Description
    Powderfree Latex Examination Gloves (Polymer Coated) (Protein Label Claim) 50
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    K Number
    K993457
    Device Name
    POWDERFREE LATEX EXAMINATION GLOVES (PROTEIN LABEL CLAIM) [50 MICROGRAMS OR LESS]
    Date Cleared
    1999-12-02

    (50 days)

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

    SRI JOHANI SDN. BHD.

    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 the examiner's hand or finger to pervent contamination between patient and examiner.
    Device Description
    Powderfree Latex Examination Gloves (Protein Label Claim) C 50mcg of
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    K Number
    K993458
    Device Name
    POWDERED LATEX EXAMINATION GLOVES (PROTEIN LABEL CLAIM)
    Date Cleared
    1999-11-10

    (28 days)

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

    SRI JOHANI SDN. BHD.

    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 the examiner's hand or finger to prevent contamination between patient and examiner.
    Device Description
    Powdered Latex Examination Gloves (Protein Trade Name: Label Claim) [150 Micrograms or Less]
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    K Number
    K981039
    Device Name
    POWDERFREE GREEN NITRILE EXAMINATION GLOVES (POLYMER COATED)
    Date Cleared
    1998-04-21

    (33 days)

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

    SRI JOHANI SDN. BHD.

    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 the examiner's hand or finger to prevent contamination between patient and examiner.
    Device Description
    Powderfree Green Nitrile Examination Gloves (Polymer Coated)
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    K Number
    K980037
    Device Name
    POWDERFREE GREEN LATEX EXAMINATION GLOVES (POLYMER COATED)
    Date Cleared
    1998-02-09

    (35 days)

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

    SRI JOHANI SDN. BHD.

    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 the examiner's hand or finger to prevent contamination between patient and examiner.
    Device Description
    Powderfree Green Latex Examination Gloves ( Polymer Coated )
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    K Number
    K980038
    Device Name
    POWDERFREE GREEN LATEX EXAMINATION GLOVES
    Date Cleared
    1998-02-09

    (35 days)

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

    SRI JOHANI SDN. BHD.

    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 the examiner's hand or finger to prevent contamination between patient and examiner.
    Device Description
    Powderfree Green Latex Examination Gloves
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    K Number
    K980039
    Device Name
    POWDERED GREEN LATEX EXAMINATION GLOVES
    Date Cleared
    1998-02-09

    (35 days)

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

    SRI JOHANI SDN. BHD.

    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 the examiner's hand or finger to prevent contamination between patient and examiner.
    Device Description
    Powdered Green Latex Examination Gloves
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    K Number
    K974886
    Device Name
    POWDERED GREEN NITRILE EXAMINATION GLOVES
    Date Cleared
    1998-01-30

    (31 days)

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

    SRI JOHANI SDN. BHD.

    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 the examiner's hand or finger to prevent contamination between patient and examiner.
    Device Description
    Powdered Green Nitrile Examination Gloves
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    K Number
    K974887
    Device Name
    POWDERFREE GREEN NITRILE EXAMINATION GLOVES
    Date Cleared
    1998-01-29

    (30 days)

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

    SRI JOHANI SDN. BHD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Patient Examination Glove is a disposable device intended for medical purpose that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.
    Device Description
    Powderfree Green Nitrile Examination Gloves
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    K Number
    K974183
    Device Name
    POLYMER NITRILE EXAMINATION GLOVES (BLUE COLOUR)
    Date Cleared
    1997-12-18

    (42 days)

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

    SRI JOHANI SDN. BHD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    A Patient Examination Glove is a disposable device intended to be worn on the examiner's hand or finger to prevent contamination between patient and examiner.
    Device Description
    Pouderfree Blue Nitrile Examination Gloves Polymer Coated
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