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    FDA 510(k) FDA class 1 Substantially Equivalent 🇨🇳 China

    SYNTEX POWDER-FREE NITRILE EXAMINATION GLOVE

    K Number: K020493 · Decision Feb 26, 2002
    View on FDA
    Classifications
    1
    FEI Numbers
    444
    Registration Numbers
    445
    Same Product Code
    1158
    Applicant Total
    14
    Review Days
    13

    Basic Information

    Device Name
    SYNTEX POWDER-FREE NITRILE EXAMINATION GLOVE
    K Number
    K020493
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    880.6250
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    SYNTEX HEALTHCARE PRODUCTS CO. LTD.
    Date Received
    February 13, 2002
    Decision Date
    February 26, 2002
    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 SYNTEX HEALTHCARE PRODUCTS CO. LTD.

    K Number Device Name
    K102096 POWDER FREE NITRILE EXAMINATION GLOVES, BLUE
    K052877 POWDER FREE NITRILE BLUE TEXTURED EXAMINATION GLOVE
    K042226 SYNTEX POWDER-FREE NITRILE EXAMINATION GLOVE, TESTED FOR CHEMOTHERAPY
    K033777 ULTRASENSE AF BLUE POWDER-FREE NITRILE EXAMINATION GLOVES
    K023826 SYNTEX POWDER-FREE LATEX EXAMINATION GLOVE-BLUE COLOR
    K022784 SYNTEX POWDER-FREE NITRILE EXAMINATION GLOVE, PURPLE COLOR
    K022146 SYNTEX POWDER-FREE POLYMER-COATED LATEX EXAMINATION GLOVE
    K022088 SYNTEX POWDER-FREE LATEX EXAMINATION GLOVE
    K022092 SYNTEX PRE-POWDERED LATEX EXAMINATION GLOVE
    K022090 SYNTEX PRE-POWDERED NITRILE EXAMINATION GLOVE
    Search all 14 clearances from SYNTEX HEALTHCARE PRODUCTS CO. LTD. →