BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

    POWDER FREE NATURAL RUBBER LATEX PATIENT EXAMINATION GLOVES WITH LABELING PROTEIN CONTENT CLAIM (50 MICROGRAMS OR LESS)

    K Number: K043014 · Decision Jan 28, 2005
    View on FDA
    Classifications
    1
    FEI Numbers
    151
    Registration Numbers
    151
    Same Product Code
    1953
    Applicant Total
    2
    Review Days
    87

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    Basic Information

    Device Name
    POWDER FREE NATURAL RUBBER LATEX PATIENT EXAMINATION GLOVES WITH LABELING PROTEIN CONTENT CLAIM (50 MICROGRAMS OR LESS)
    K Number
    K043014
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    880.6250
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Shijiazhuang Tillotson Rubber Products Co., Ltd.
    Date Received
    November 2, 2004
    Decision Date
    January 28, 2005
    Product Code
    LYY
    Advisory Committee
    General Hospital
    Review Advisory Committee
    HO
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    LYY Latex Patient Examination Glove

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    Other Clearances by Shijiazhuang Tillotson Rubber Products Co., Ltd.

    K Number Device Name
    K042378 NON-STERILE POWDER FREE BLUE NITRILE PATIENT EXAMINATION GLOVE