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

    NON-STERILE POWDER FREE BLUE NITRILE PATIENT EXAMINATION GLOVE

    K Number: K042378 · Decision Sep 20, 2004
    View on FDA
    Classifications
    1
    FEI Numbers
    380
    Registration Numbers
    380
    Same Product Code
    1171
    Applicant Total
    2
    Review Days
    19

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    Basic Information

    Device Name
    NON-STERILE POWDER FREE BLUE NITRILE PATIENT EXAMINATION GLOVE
    K Number
    K042378
    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
    September 1, 2004
    Decision Date
    September 20, 2004
    Product Code
    LZA
    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
    LZA Polymer Patient Examination Glove

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

    K Number Device Name
    K043014 POWDER FREE NATURAL RUBBER LATEX PATIENT EXAMINATION GLOVES WITH LABELING PROTEIN CONTENT CLAIM (50 MICROGRAMS OR LESS)