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

    POLYCOAT POWDERED LATEX EXAMINATION GLOVE WITH ALOE VERA & PROTEIN CONTENT LABELING CLAIM (200 MICROGRAMS OR LESS)

    K Number: K013254 · Decision Feb 4, 2002
    View on FDA
    Classifications
    1
    FEI Numbers
    380
    Registration Numbers
    380
    Same Product Code
    1171
    Applicant Total
    4
    Review Days
    129

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    Basic Information

    Device Name
    POLYCOAT POWDERED LATEX EXAMINATION GLOVE WITH ALOE VERA & PROTEIN CONTENT LABELING CLAIM (200 MICROGRAMS OR LESS)
    K Number
    K013254
    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
    September 28, 2001
    Decision Date
    February 4, 2002
    Product Code
    LZA
    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
    LZA Polymer 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)
    K004018 SKINGARD POLYCOAT GLOVE
    K000050 TOP QUALITY CHLORINATED-POWDERFREE EXAMINATION GLOVES