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510(k) Data Aggregation

    K Number
    K964819
    Device Name
    SHENG HO
    Date Cleared
    1998-01-06

    (400 days)

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

    SHANG HO INDUSTRIAL CORP. LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    A medical glove is worn on the hand of healthcare and similar personnel to prevent contamination between healthcare personnel and patient.
    Device Description
    Powder Free Latex Patient Examination Gloves
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    K Number
    K970795
    Device Name
    SHANG HO
    Date Cleared
    1997-12-18

    (289 days)

    Product Code
    Regulation Number
    878.4460
    Why did this record match?
    Applicant Name (Manufacturer) :

    SHANG HO INDUSTRIAL CORP. LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    A Surgeon's Gloves is worn on the hand of operating room personnel to protect surgical wound from contamination and prevent contaimination between operating room personnel and patient.
    Device Description
    Powder Free SterikSurgeon's Gloves
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