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510(k) Data Aggregation

    K Number
    K213413
    Device Name
    Hemostatic Dressing
    Date Cleared
    2023-09-01

    (682 days)

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

    Jiangsu NewValue Medical Products Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Indications for Use (Rx): Hemostatic Dressing is intended for the external, temporary control of severely bleeding wounds. Indications for Use (OTC): Hemostatic Dressing is intended for temporary external use to stop bleeding of minor wounds, minor cuts and minor abrasions.
    Device Description
    Hemostatic Dressing is a sterile non-woven fabric dressing composed of hydrophilic fiber (a mixture of chitosan and chitosan derivative). When applied directly over a wound with pressure, this soft and highly absorbent dressing quickly absorbs blood and turns into a gel to seal the wound. It promotes control of wound bleeding and exudates absorption and promotes coagulation.
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    K Number
    K202491
    Device Name
    Disposable Surgical Face Mask
    Date Cleared
    2021-01-06

    (128 days)

    Product Code
    Regulation Number
    878.4040
    Why did this record match?
    Applicant Name (Manufacturer) :

    Jiangsu NewValue Medical Products Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Disposable Surgical Face Masks are intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids, and particulate material. These face masks are intended for use in infection control practices to reduce the potential exposure to blood and body fluids. This is a single-use, disposable device, provided non-sterile.
    Device Description
    Disposable Surgical Face Mask is composed of three layers and is flat-pleated. The mask materials consist of an outer layer (spun-bond polypropylene), a middle layer, between the outer layer and inner layers (melt-blown polypropylene), and an inner layer (spun-bond polypropylene). Each mask contains tie strings (spun-bond polypropylene) or ear loops (Spandex elastic cord) to secure the mask over the users' mouth and face and includes a malleable nose piece (iron wire with plastic covering) to provide a firm fit over the nose.
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