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

    POWDER FREE NITRILE BLUE TEXTURED EXAMINATION GLOVE

    K Number: K052877 · Decision Nov 8, 2005
    View on FDA
    Classifications
    1
    FEI Numbers
    444
    Registration Numbers
    445
    Same Product Code
    1158
    Applicant Total
    14
    Review Days
    27

    Basic Information

    Device Name
    POWDER FREE NITRILE BLUE TEXTURED EXAMINATION GLOVE
    K Number
    K052877
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    880.6250
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    SYNTEX HEALTHCARE PRODUCTS CO. LTD.
    Date Received
    October 12, 2005
    Decision Date
    November 8, 2005
    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
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    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
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    K021058 SYNTEX POWDER-FREE MULTI-PLY LATEX EXAMINATION GLOVES WITH LOW PROTEIN CLAIM
    Search all 14 clearances from SYNTEX HEALTHCARE PRODUCTS CO. LTD. →