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510(k) Data Aggregation

    K Number
    K192933
    Device Name
    Polyisoprene Powder Free, Black Colour Surgical Gloves
    Manufacturer
    Emerson & Co. Srl
    Date Cleared
    2021-01-13

    (454 days)

    Product Code
    KGO
    Regulation Number
    878.4460
    Why did this record match?
    Applicant Name (Manufacturer) :

    **Emerson **& Co

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Polyisoprene Powder Free, Black Colour Surgical Gloves are radiation attenuating and intended to be worn by operating room personnel to protect a surgical wound from contamination.
    Device Description
    Polyisoprene Powder Free, Black Colour Surgical Gloves Model 1: 0.22 mm Model 2: 0.30 mm
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    K Number
    K151228
    Device Name
    PROGUARD Polyisoprene Powder Free, Black Colour Surgical Gloves, Model 1: .22mm Model 2: .30mm
    Manufacturer
    EMERSON & CO. S.R.L.
    Date Cleared
    2016-01-15

    (253 days)

    Product Code
    KGO
    Regulation Number
    878.4460
    Why did this record match?
    Applicant Name (Manufacturer) :

    **EMERSON **& CO

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The PROGUARD Polyisoprene Powder Free, Black Colour Surgical Gloves are radiation attenuating and intended to be worn by operating room personnel to protect a surgical wound from contamination.
    Device Description
    PROGUARD Polyisoprene Powder Free, Black Colour Surgical Gloves Model 1: 0.22mm Model 2: 0.30mm
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    K Number
    K002598
    Device Name
    EMERSON COUGH ASSIST MODEL CA-3000 W/AUTOMATIC TIMING AND MODEL CM-3000 W/MANUAL TIMING
    Manufacturer
    J. H. EMERSON CO.
    Date Cleared
    2000-11-22

    (93 days)

    Product Code
    NHJ
    Regulation Number
    868.5905
    Why did this record match?
    Applicant Name (Manufacturer) :

    **EMERSON **CO

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K982832
    Device Name
    PROGUARD, RR-1, RR-2
    Manufacturer
    EMERSON & CO. S.R.L.
    Date Cleared
    1998-12-23

    (133 days)

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

    **EMERSON **& CO

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The X-Ray protection gloves PROGUARD are sterile examination gloves, radio-opaque, to be worn by hospital personnel, specifically surgeons, to protect their hands from radiation during operation of x-ray equipment. These gloves are destined to specific examination purposes. They are not intended to be used instead of a Radiographic Protective Gloves, normally used in radiography for those studies which need the physician's hands or forearms to be inserted intop the primary x-ray beam, but not the sterility or the degree of manual dexterity allowed by the PROGUARD. Moreover these gloves are not to be used in or next to the primary x-ray beam or conducted primary x-ray beam. The main purpose of these gloves is to reduce the amount of dispersed radiation exposure to the hands from the primary x-ray beam during examinations or procedures under fluoroscopy performance.
    Device Description
    This product contains natural rubber latex. The gloves are a product of Malaysia. The manufacturer of these latex-lead gloves complies with all the current specifications listed under The American ociety for testing and Materials (ASTM) Specification D 3578 -91 and FDA Water Leak Test. The quality assurance testing for the finished product includes testing for physical properties such as tensile strength and elongation: dimensions such as length, width and thickness; visual tests such as colour and material uniformity. In addition, sampling and testing for leaks conforms to the FDA Water Leak Test for patient examination gloves.
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