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510(k) Data Aggregation

    K Number
    K972277
    Device Name
    DIGIFLEX SURGICAL GLOVES
    Manufacturer
    Date Cleared
    1997-10-21

    (125 days)

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

    HMS SERVICES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    A Surgical Glove is a device made of natural or Synthetic rubber, intended to be worn by operating room personnel to protect a surgical wound from contamination.
    Device Description
    Sterile Surgical Glove ( POWDERE
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