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

    DISPOSABLE PVC POWDERED SYNTHETIC EXAM GLOVES

    K Number: K001601 · Decision Jun 23, 2000
    View on FDA
    Classifications
    1
    FEI Numbers
    131
    Registration Numbers
    131
    Same Product Code
    798
    Applicant Total
    6
    Review Days
    30

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    Basic Information

    Device Name
    DISPOSABLE PVC POWDERED SYNTHETIC EXAM GLOVES
    K Number
    K001601
    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 PT Plastics Enterprise Company, Ltd.
    Date Received
    May 24, 2000
    Decision Date
    June 23, 2000
    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 PT Plastics Enterprise Company, Ltd.

    K Number Device Name
    K022087 DISPOSABLE POWDER FREE VINYL SYNTHETIC EXAM GLOVES WITH ALOE VERA, GREEN COLOR
    K002870 DISPOSABLE POWDER FREE VINYL SYNTHETIC EXAM GLOVES, WHITE COLOR
    K001611 DISPOSABLE PVC SYNTHETIC EXAMINATION GLOVES, POWDER FREE
    K961521 PATIENT EXAMINATION GLOVE
    K963751 PT SYNTHETIC MEDICAL GLOVES, POWDER FREE