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510(k) Data Aggregation

    K Number
    K012067
    Device Name
    CLINCARE LATEX SURGEON'S GLOVE
    Date Cleared
    2001-09-17

    (77 days)

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

    TTK HEALTHCARE LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    This Surgeon's Glove is a device made of natural rubber latex intended to be worn by operating room personnel to protect a surgical wound from contamination
    Device Description
    CLINCARE Latex Surgical Gloves are class I powdered surgeon's gloves, powdered with absorbable dusting powder, and meet all the requirements of ASTM D 3577.
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