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510(k) Data Aggregation

    K Number
    K022256
    Device Name
    SURGICAL FACE MASK - COLORS: WHITE, YELLOW, PINK, BLUE, AND GREEN
    Manufacturer
    TUCKER & ASSOCIATES
    Date Cleared
    2004-04-26

    (654 days)

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

    **TUCKER **& ASSOCIATES

    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
    Non-sterile surgical face mask, white, yellow, pink, blue and green.
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    K Number
    K980827
    Device Name
    LATEX FINGER COT, POWDER-FREE, WITH PROTEIN LABELING
    Manufacturer
    TUCKER & ASSOCIATES
    Date Cleared
    1998-05-04

    (62 days)

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

    **TUCKER **& ASSOCIATES

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    A finger cot is a disposable device intended for medical purposes that is worn on the examiner's finger to prevent contamination between patient and examiner.
    Device Description
    Latex Finger Cot, Powder-Free, with Protein Labeling
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    K Number
    K980802
    Device Name
    NITRILE EXAM GLOVE, POWDER-FREE, BLUE
    Manufacturer
    TUCKER & ASSOCIATES
    Date Cleared
    1998-03-25

    (23 days)

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

    **TUCKER **& ASSOCIATES

    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
    Nitrile Exam Gloves, Powder-Free, Blue
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    K Number
    K970835
    Device Name
    FACE MASK, SURGICAL MASK, NON-STERILE
    Manufacturer
    TUCKER & ASSOCIATES
    Date Cleared
    1997-09-03

    (196 days)

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

    **TUCKER **& ASSOCIATES

    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
    FACE MASK, SURGICAL
    Ask a Question

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