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510(k) Data Aggregation

    K Number
    K030927
    Device Name
    POWDERED VINYL EXAM GLOVES, WHITE
    Manufacturer
    COPIOUMED INTL., INC.
    Date Cleared
    2003-04-17

    (24 days)

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

    COPIOUMED INTL., INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    A patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.
    Device Description
    POWDERED VINYL EXAM GLOVES, WHITE, Class I Device, 80LYZ. A patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.
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    K Number
    K021961
    Device Name
    POWDER-FREE POLY-VINYL EXAM GLOVES, COLOR: WHITE
    Manufacturer
    COPIOUMED INTL., INC.
    Date Cleared
    2002-07-02

    (18 days)

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

    COPIOUMED INTL., INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    A patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.
    Device Description
    POWDER-FREE POLY-VINYL EXAM GLOVES, COLOR: WHITE
    Ask a Question
    K Number
    K021743
    Device Name
    (MULTIPLE LABELS) POWDER-FREE POLY-VINYL EXAM GLOVES, COLOR: YELLOW
    Manufacturer
    COPIOUMED INTL., INC.
    Date Cleared
    2002-06-10

    (13 days)

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

    COPIOUMED INTL., INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    A patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.
    Device Description
    POWDER-FREE POLY-VINYL EXAM GLOVES, COLOR: YELLOW
    Ask a Question
    K Number
    K972624
    Device Name
    POLY (VINYL) EXAM GLOVE, POWDER-FREE
    Manufacturer
    COPIOUMED INTL., INC.
    Date Cleared
    1997-11-06

    (115 days)

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

    COPIOUMED INTL., INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    A patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.
    Device Description
    PATIENT EXAMINATION GLOVE, POLY (VINYL), POWDER FREE
    Ask a Question
    K Number
    K965237
    Device Name
    NURSES BOUFFANT CAP
    Manufacturer
    COPIOUMED INTL., INC.
    Date Cleared
    1997-08-27

    (239 days)

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

    COPIOUMED INTL., INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    This device is intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids and particulate material.
    Device Description
    CAP, BOUFFANT, NURSES SURGICAL WHITE, BLUE, & GREEN
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    K Number
    K971316
    Device Name
    POLY (VINYL) EXAM GLOVE, POWDERED
    Manufacturer
    COPIOUMED INTL., INC.
    Date Cleared
    1997-08-27

    (140 days)

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

    COPIOUMED INTL., INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    A patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.
    Device Description
    PATIENT EXAMINATION GLOVE, POLY (VINYL), POWDERED
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    K Number
    K960999
    Device Name
    ISOLATION GOWN
    Manufacturer
    COPIOUMED INTL., INC.
    Date Cleared
    1996-12-30

    (293 days)

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

    COPIOUMED INTL., INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
    Ask a Question
    K Number
    K961342
    Device Name
    SHOE COVER, NON-STERILE
    Manufacturer
    COPIOUMED INTL., INC.
    Date Cleared
    1996-12-30

    (285 days)

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

    COPIOUMED INTL., INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
    Ask a Question

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