Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K223270
    Device Name
    POSE™ Health Care Surgical Mask
    Date Cleared
    2022-11-01

    (8 days)

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

    America's Supply Chains

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The POSE™ Health Care Surgical Mask is intended to be worn by operating room personnel during surgical procedures to protect both the surgical patient and the operating room personnel from transfer of microorganisms, body fluids, and particulate material.
    Device Description
    POSE™ Health Care Surgical Mask is composed of three-layers and is flat fold. The mask materials consist of an outer cover web (polypropylene spunbond, white), filter web (polypropylene melt-blown, white) and inner cover web (polypropylene thermal-bonded, white). Each mask contains ear loops to secure the mask to the user's face and mouth, as well as a fully enclosed, soft, bendable nose piece to fit over the nose. This device is not made from natural rubber latex.
    Ask a Question

    Ask a specific question about this device

    Page 1 of 1