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

    ALCATRON AND / OR MULTIPLE BRAND

    K Number: K112222 · Decision Oct 27, 2011
    View on FDA
    Classifications
    1
    FEI Numbers
    131
    Registration Numbers
    131
    Same Product Code
    798
    Applicant Total
    2
    Review Days
    86

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    Basic Information

    Device Name
    ALCATRON AND / OR MULTIPLE BRAND
    K Number
    K112222
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    880.6250
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Alcatron Gloves Factory
    Date Received
    August 2, 2011
    Decision Date
    October 27, 2011
    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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