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510(k) Data Aggregation

    K Number
    K013958
    Device Name
    INDUS TEXTILES TOWEL-STERILE AND NON-STERILE
    Date Cleared
    2002-08-19

    (262 days)

    Product Code
    Regulation Number
    878.4370
    Why did this record match?
    Applicant Name (Manufacturer) :

    INDUS TEXTILES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    This is a single use disposable surgical towel intended to be used as a protective patient covering, such as to isolate a site of surgical incision from microbial and other contamination. The O.R. Towel is further used as a fluid-absorbing towel during surgery or as a device to dry hands of the O.R. personnel. This is a single use disposable surgical towel intended to be used as a protective patient covering, such as to isolate a site of surgical incision from microbial and other contamination. The O.R. towel is also to be used for the absorption of fluids, including blood and body fluids or as a general use towel for drying hands.
    Device Description
    The Indus Textiles O.R. Towels are made of 100% cotton that have been pre-washed and delinted. The towels are offered sterile and non-sterile and are available in blue.
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