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510(k) Data Aggregation

    K Number
    K051923
    Device Name
    POWDERED VINYL PATIENT EXAMINATION GLOVES WHITE (NON-COLORED)
    Manufacturer
    SHIJIAZHUANG WONDER PLASTIC CO., LTD.
    Date Cleared
    2005-08-16

    (32 days)

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

    SHIJIAZHUANG **WONDER **PLASTIC CO

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Powdered vinyl patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.
    Device Description
    powdered vinyl patient examination gloves, white(non-colored) that meets all of the requirements of ASTM standard I) 525()-00'd
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    K Number
    K051935
    Device Name
    POWDER FREE VINYL PATIENT EXAMINATION GLOVES, WHITE (NON-COLORED)
    Manufacturer
    SHIJIAZHUANG WONDER PLASTIC CO., LTD.
    Date Cleared
    2005-08-02

    (18 days)

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

    SHIJIAZHUANG **WONDER **PLASTIC CO

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Powder free vinyl patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.
    Device Description
    powder free vinyl patient examination gloves, white(non-colored) that meets all of the requirements of ASTM standard D 5250-00-4
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    K Number
    K990974
    Device Name
    VITOP DRESSING
    Manufacturer
    WONDER & BIOENERGY HI-TECH AMERICA, INC.
    Date Cleared
    1999-06-09

    (78 days)

    Product Code
    EFQ
    Regulation Number
    N/A
    Why did this record match?
    Applicant Name (Manufacturer) :

    **WONDER **& BIOENERGY HI-TECH AMERICA, INC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Management of venous cuts, for example, cuts resulting from any shape objects and abrasions, other superficial injuries, superficial wounds, burns (1st and 2nd degree) donor sites, post operative wound.
    Device Description
    vitop® Dressing
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