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

    DISPOSABLE VINYL EXAMINATION GLOVE, POWDERED

    K Number: K082444 · Decision Sep 30, 2008
    View on FDA
    Classifications
    1
    FEI Numbers
    131
    Registration Numbers
    131
    Same Product Code
    798
    Applicant Total
    7
    Review Days
    36

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    Basic Information

    Device Name
    DISPOSABLE VINYL EXAMINATION GLOVE, POWDERED
    K Number
    K082444
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    880.6250
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Rich Mountain Medical Products, Inc.
    Date Received
    August 25, 2008
    Decision Date
    September 30, 2008
    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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    Other Clearances by Rich Mountain Medical Products, Inc.

    K Number Device Name
    K120190 DISPOSABLE POWDER FREE VINYL EXAM GLOVE, BLUE COLOR
    K082448 DISPOSABLE VINYL SYNTHETIC EXAMINATION GLOVES, POWDERED
    K082447 DISPOSABLE VINYL EXAMINATION GLOVE, POWDER FREE
    K082443 DISPOSABLE SYNTHETIC EXAMINATION GLOVES, POWDER FREE
    K081539 DISPOSABLE POWDER FREE VINYL SYNTHETIC EXAM GLOVES WITH ALOE VERA, GREEN COLOR
    K081535 DISPOSABLE POWDER FREE VINYL SYNTHETIC EXAM GLOVES, WHITE COLOR