BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇹🇼 Taiwan

    POWDER FREE ELASTIC VINYL EXAMINATION GLOVES

    K Number: K010829 · Decision Apr 5, 2001
    View on FDA
    Classifications
    1
    FEI Numbers
    131
    Registration Numbers
    131
    Same Product Code
    798
    Applicant Total
    6
    Review Days
    16

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    Basic Information

    Device Name
    POWDER FREE ELASTIC VINYL EXAMINATION GLOVES
    K Number
    K010829
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    880.6250
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    General Gloves Corp.
    Date Received
    March 20, 2001
    Decision Date
    April 5, 2001
    Product Code
    LYZ
    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
    LYZ Vinyl Patient Examination Glove

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    Other Clearances by General Gloves Corp.

    K Number Device Name
    K024338 POWDER FREE VINYL EXAM GLOVES WITH ALOE COATING INSIDE
    K024174 NON-DEHP, POWDER FREE VINYL EXAMINATION GLOVES
    K010830 POWDER FREE TEXTURED VINYL EXAMINATION GLOVES
    K992107 BALDUR BRAND VINYL POWDERED EXAMINATION GLOVES
    K982933 VINYL EXAMINATION GLOVES, POWDER FREE