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510(k) Data Aggregation

    K Number
    K152690
    Device Name
    DISPOSABLE THERMOMETER PROBE SHEATHS
    Date Cleared
    2016-01-15

    (116 days)

    Product Code
    Regulation Number
    880.2910
    Why did this record match?
    Applicant Name (Manufacturer) :

    PINGHU SAMA MEDICAL PACKING CO., LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Disposable Thermometer Probe Sheaths are intended for use as barriers between digital thermometers and users' oral cavities to avoid the possible contamination and infection during temperature measuring. The sheaths are non-sterile and intended for single use only.
    Device Description
    The Disposable Thermometer Probe Sheaths are used for oral measurements for digital thermometers. The products and packaging are non-sterile, not made with natural rubber latex, and intended for single patient use only. The proposed device is a shell-like device, made of PE/EVA, use to cover the oral thermometer as barrier for avoiding possible contamination and infection during measurement of temperature. The device is covered by the paper (Medical Kraft Paper) at the top and bottom which to avoid unnecessary touch with the device before usage and will be removed from the device before use. The outer most packing material is carton box. Each outer packing contains 100 pieces of the device.
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    K Number
    K141998
    Device Name
    SAMA DISPOSABLE BLOOD PRESSURE CUFF BARRIERS
    Date Cleared
    2014-09-19

    (58 days)

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

    PINGHU 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 to 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 soft medical grade paper with a polyethylene coating. 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 barrier 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 barrier 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 barrier has the potential to reduce transfer of patient contamination to the cuff and from the cuff to the patient. The blood pressure cuff barrier is a single use product designed to survive average use during an average hospital stay. If the blood pressure cuff cover becomes contaminated, soiled or torn during this time it would be replaced with a new blood pressure cuff barrier. The blood cuff barrier has a two layer structure. The inner layer that has immediate contact with patient skin is made of soft medical grade paper. The outer layer that has immediate contact underneath the blood pressure cuff is made of cast film of polyethylene. The whole barrier is approximately 20 um thick and is available in various different length and width. The barrier can be secured around the patient arm by two sided adhesive tape with removable liner. The adhesive tape and liner are located at the end of outer layer and do not contact the patient skin.
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