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510(k) Data Aggregation

    K Number
    K113749
    Device Name
    DISPOSABLE POWDER FREE VINYL SYNTHETIC EXAM GLOVES, WITH ALOE VERA, GREEN COLOR
    Date Cleared
    2012-03-15

    (85 days)

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

    FULL SYNERGY MEDICAL PRODUCTS INC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    A PATIENT EXAMINATION GLOVES 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, With Aloe Vera, Green Color
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    K Number
    K113790
    Device Name
    DISPOSABLE VINYL EXAM GLOVE, POWDERED
    Date Cleared
    2012-03-06

    (74 days)

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

    FULL SYNERGY MEDICAL PRODUCTS INC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    A PATIENT EXAMINATION GLOVES 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 Vinyl Exam Glove, Powdered
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    K Number
    K113750
    Device Name
    DISPOSABLE POWDER FREE VINYL EXAM GLOVE, WHITE COLOR
    Date Cleared
    2012-03-05

    (75 days)

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

    FULL SYNERGY MEDICAL PRODUCTS INC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    A PATIENT EXAMINATION GLOVES 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 Glove, White Color
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    K Number
    K113797
    Device Name
    DISPOSABLE VINYL EXAM GLOVE, POWDER FREE
    Date Cleared
    2012-03-02

    (70 days)

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

    FULL SYNERGY MEDICAL PRODUCTS INC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    A PATIENT EXAMINATION GLOVES IS A DISPOSABLE DEVICE INTENDED A FATIENT EXAMINATION ODD THE EXAMINER'S HAND OR SEARCH AND FOR MEDIOAL POR! OUD OF AND AND ATION BETWEEN PATIENT AND EXAMINER.
    Device Description
    Disposable Vinyl Exam Glove, Powder Free
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    K Number
    K113710
    Device Name
    DISPOSABLE POWDER FREE VINYL EXAM GLOVE, YELLOW COLOR
    Date Cleared
    2012-02-14

    (57 days)

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

    FULL SYNERGY MEDICAL PRODUCTS INC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    A PATIENT EXAMINATION GLOVES 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 Glove, Yellow Color
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    K Number
    K113722
    Device Name
    DISPOSABLE POWDER FREE VINYL EXAM GLOVE, BLUE COLOR
    Date Cleared
    2012-02-14

    (57 days)

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

    FULL SYNERGY MEDICAL PRODUCTS INC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    A PATIENT EXAMINATION GLOVES 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 Glove, Blue Color
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