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

    SKINGARD POLYCOAT GLOVE

    K Number: K004018 · Decision May 11, 2001
    View on FDA
    Classifications
    1
    FEI Numbers
    151
    Registration Numbers
    151
    Same Product Code
    1953
    Applicant Total
    4
    Review Days
    135

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    Basic Information

    Device Name
    SKINGARD POLYCOAT GLOVE
    K Number
    K004018
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    880.6250
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Top Quality Mfg., Inc.
    Date Received
    December 27, 2000
    Decision Date
    May 11, 2001
    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 Top Quality Mfg., Inc.

    K Number Device Name
    K013821 SILK TOUCH POWDERED LATEX EXAMINATION GLOVE WITH PROTEIN CONTENT LABELING CLAIM (200 MICROGRAMS OR LESS)
    K013254 POLYCOAT POWDERED LATEX EXAMINATION GLOVE WITH ALOE VERA & PROTEIN CONTENT LABELING CLAIM (200 MICROGRAMS OR LESS)
    K000050 TOP QUALITY CHLORINATED-POWDERFREE EXAMINATION GLOVES