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

    OMNI GRIP LATEX EXAMINATION GLOVE, POWDER-FREE

    K Number: K970297 · Decision Feb 25, 1997
    View on FDA
    Classifications
    1
    FEI Numbers
    169
    Registration Numbers
    169
    Same Product Code
    1953
    Applicant Total
    2
    Review Days
    29

    Basic Information

    Device Name
    OMNI GRIP LATEX EXAMINATION GLOVE, POWDER-FREE
    K Number
    K970297
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    880.6250
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    OMNI SALES CORP.
    Date Received
    January 27, 1997
    Decision Date
    February 25, 1997
    Product Code
    LYY
    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
    LYY Latex Patient Examination Glove

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    Other Clearances by OMNI SALES CORP.

    K Number Device Name
    K964563 OMNI GRIP LATEX EXAMINATION GLOVE, POWDER-FREE