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510(k) Data Aggregation

    K Number
    K032172
    Device Name
    DISPOSABLE POWDER FREE VINYL EXAM GLOVES
    Manufacturer
    SYNMERTEX CO, LTD
    Date Cleared
    2003-08-14

    (29 days)

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

    SYNMERTEX CO, LTD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    A PATIENT EXAMINATION GLOVE IS A DISPOSABLE DEVICE INTENDED FOR MEDICAL PURPOSE THAT IS WORN ON THE EXAMINER'S HAND OR FINGERS TO PREVENT CONTAMINATION BETWEEN PATIENT AND EXAMINER.
    Device Description
    DISPOSABLE POWDER FREE VINYL EXAM GLOVES
    Ask a Question
    K Number
    K032190
    Device Name
    DISPOSABLE POWDERED VINYL EXAM GLOVES
    Manufacturer
    SYNMERTEX CO, LTD
    Date Cleared
    2003-08-14

    (28 days)

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

    SYNMERTEX CO, LTD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    A PATIENT EXAMINATION GLOVE IS A DISPOSABLE DEVICE INTENDED FOR MEDICAL PURPOSE THAT IS WORN ON THE EXAMINER'S HAND OR FINGERS TO PREVENT CONTAMINATION BETWEEN PATIENT AND EXAMINER.
    Device Description
    DISPOSABLE POWDERED VINYL EXAM GLOVES
    Ask a Question
    K Number
    K031076
    Device Name
    DISPOSABLE POWDER FREE VINYL SYNTHETIC EXAM GLOVES WHITE COLOR
    Manufacturer
    SYNMERTEX CO, LTD
    Date Cleared
    2003-05-23

    (49 days)

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

    SYNMERTEX CO, LTD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    A PATIENT EXAMINATION GLOVE IS A DISPOSABLE DEVICE INTENDED FOR MEDICAL PURPOSE THAT IS WORN ON THE EXAMINER'S HAND OR FINGERS TO PREVENT CONTAMINATION BETWEEN PATIENT AND EXAMINER.
    Device Description
    DISPOSABLE POWDER FREE VINYL SYNTHETIC EXAM GLOVES WHITE COLOR
    Ask a Question
    K Number
    K031120
    Device Name
    DISPOSABLE POWDER FREE VINYL SYNTHETIC EXAM GLOVES
    Manufacturer
    SYNMERTEX CO, LTD
    Date Cleared
    2003-05-23

    (45 days)

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

    SYNMERTEX CO, LTD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    A PATIENT EXAMINATION GLOVE IS A DISPOSABLE DEVICE INTENDED FOR MEDICAL PURPOSE THAT IS WORN ON THE EXAMINER'S HAND OR FINGERS TO PREVENT CONTAMINATION BETWEEN PATIENT AND EXAMINER.
    Device Description
    DISPOSABLE POWDER FREE VINYL SYNTHETIC EXAM GLOVES
    Ask a Question
    K Number
    K031171
    Device Name
    DISPOSABLE POWDERED VINYL SYNTHETIC EXAM GLOVES
    Manufacturer
    SYNMERTEX CO, LTD
    Date Cleared
    2003-05-23

    (39 days)

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

    SYNMERTEX CO, LTD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    A PATIENT EXAMINATION GLOVE IS A DISPOSABLE DEVICE INTENDED FOR MEDICAL PURPOSE THAT IS WORN ON THE EXAMINER'S HAND OR FINGERS TO PREVENT CONTAMINATION BETWEEN PATIENT AND EXAMINER.
    Device Description
    DISPOSABLE POWDERED VINYL SYNTHETIC EXAM GLOVES
    Ask a Question

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