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510(k) Data Aggregation

    K Number
    K024026
    Device Name
    DISPOSABLE POWDER FREE VINYL SYNTHETIC EXAM GLOVES WITH ALOE VERA, GREEN COLOR
    Manufacturer
    SHANGHAI PM PLASTICS ENTERISE CO., LTD.
    Date Cleared
    2002-12-18

    (12 days)

    Product Code
    LYZ
    Regulation Number
    880.6250
    Why did this record match?
    Applicant Name (Manufacturer) :

    SHANGHAI PM PLASTICS ENTERISE CO., LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    A PATIENT EXAMINATION GLOVE IS A DISPOSABLE DEVICE INTENDED FOR MEDICAL PURPOSE THAT IS WORN ON THE EXAMINER'S HAND OR FINGERS TO PREVENT CONTAMINATION BETWEEN PATIENT AND EXAMINER.
    Device Description
    DISPOSABLE POWDER FREE VINYL SYNTHETIC EXAM GLOVES WITH ALOE VERA, GREEN COLOR
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    K Number
    K002814
    Device Name
    DISPOSBABLE POWDERED VINYL SYNTHETIC EXAM GLOVES, WHITE COLOR
    Manufacturer
    SHANGHAI PM PLASTICS ENTERISE CO., LTD.
    Date Cleared
    2000-10-20

    (39 days)

    Product Code
    LYZ
    Regulation Number
    880.6250
    Why did this record match?
    Applicant Name (Manufacturer) :

    SHANGHAI PM PLASTICS ENTERISE CO., LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
    Ask a Question
    K Number
    K963797
    Device Name
    PM SYNTHETIC MEDICAL GLOVES, POWDER FREE
    Manufacturer
    SHANGHAI PM PLASTICS ENTERISE CO., LTD.
    Date Cleared
    1996-10-29

    (36 days)

    Product Code
    LYZ
    Regulation Number
    880.6250
    Why did this record match?
    Applicant Name (Manufacturer) :

    SHANGHAI PM PLASTICS ENTERISE CO., LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
    Ask a Question
    K Number
    K963514
    Device Name
    PACER PLUS SYNTHETIC MEDICAL VINLY PATIENT EXAMINATION GLOVES (POWDERED)
    Manufacturer
    SHANGHAI PM PLASTICS ENTERISE CO., LTD.
    Date Cleared
    1996-10-24

    (51 days)

    Product Code
    LYZ
    Regulation Number
    880.6250
    Why did this record match?
    Applicant Name (Manufacturer) :

    SHANGHAI PM PLASTICS ENTERISE CO., LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
    Ask a Question

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