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

    UNISEAL GLOVES (LOW PROTEIN,POWDER FREE)

    K Number: K963211 · Decision Nov 22, 1996
    View on FDA
    Classifications
    1
    FEI Numbers
    151
    Registration Numbers
    151
    Same Product Code
    1953
    Applicant Total
    2
    Review Days
    98

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    Basic Information

    Device Name
    UNISEAL GLOVES (LOW PROTEIN,POWDER FREE)
    K Number
    K963211
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    880.6250
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    American Healthcare Products, Inc.
    Date Received
    August 16, 1996
    Decision Date
    November 22, 1996
    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 American Healthcare Products, Inc.

    K Number Device Name
    K062794 PRN THERMALCARE, MODEL 3000