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

    PM SYNTHETIC MEDICAL GLOVES, POWDER FREE

    K Number: K963797 · Decision Oct 29, 1996
    View on FDA
    Classifications
    1
    FEI Numbers
    131
    Registration Numbers
    131
    Same Product Code
    798
    Applicant Total
    5
    Review Days
    36

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    Basic Information

    Device Name
    PM SYNTHETIC MEDICAL GLOVES, POWDER FREE
    K Number
    K963797
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    880.6250
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Shanghai PM Plastics Enterise Co., Ltd.
    Date Received
    September 23, 1996
    Decision Date
    October 29, 1996
    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 Shanghai PM Plastics Enterise Co., Ltd.

    K Number Device Name
    K024026 DISPOSABLE POWDER FREE VINYL SYNTHETIC EXAM GLOVES WITH ALOE VERA, GREEN COLOR
    K002814 DISPOSBABLE POWDERED VINYL SYNTHETIC EXAM GLOVES, WHITE COLOR
    K963514 PACER PLUS SYNTHETIC MEDICAL VINLY PATIENT EXAMINATION GLOVES (POWDERED)
    K930266 VINYL EXAMINATION GLOVES