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510(k) Data Aggregation

    K Number
    K150227
    Device Name
    Disposable Blood Pressure Cuff Guard
    Date Cleared
    2015-04-02

    (59 days)

    Product Code
    Regulation Number
    870.1120
    Why did this record match?
    Applicant Name (Manufacturer) :

    PINHU SAMA MEDICAL PACKING CO., LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    This device has the potential to reduce or prevent patient cross contamination which can occur during blood pressure measurement procedures, for single patient use only. It covers a blood pressure cuff to provide a barrier between patient and cuff.
    Device Description
    This device is a cover for blood pressure cuffs. It is made of polyethylene coated on Tyvck. Blood pressure cuffs are used throughout the healthcare industry as a means of monitoring patient blood pressure. Because blood pressure cuffs are used on multiple patients there is a concern about cross contamination. When the blood pressure cuffs become contaminated they should be cleaned. A blood pressure cuff Guard can reduce the need to clean blood pressure cuffs. In order to address the cross contamination issue for blood pressure cuffs a blood pressure cuff Guard has been designed. The product is a non-sterile, clean, ready to use sleeve that is applied between the patient arm and the blood pressure cuff. The cuff Guard has the potential to reduce transfer of patient contamination to the cuff and from the cuff to the patient. The blood pressure cuff Guard is a single patient product designed to survive average use during an average hospital stay. If the blood pressure cuff Guard becomes contaminated, soiled or torn during this time it would be replaced with a new blood pressure cuff Guard. The blood cuff Guard has a two layer structure. The inner layer is made of Tyvck. The outer layer is made of cast film of polyethylene. The polyethylene is a fluid repellent, and is resistant to microbial penetration, thus provides a barrier between the pressure cuff and patient. The whole guard is approximately 20 um thick and is available in various different length and width. The guard is designed as pouchlike with one open, the blood pressure cuff can be packed into it and sealed with adhesive tape, and which can be secured around the patient arm by two velcro. The adhesive tapes are located at the edge of open and the Velcro located at the two ends of outer guard, both of them are not contact with the patient skin.
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