Search Filters

Search Results

Found 2 results

510(k) Data Aggregation

    K Number
    K202905
    Device Name
    Disposable Face Mask
    Date Cleared
    2021-03-26

    (178 days)

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

    Jiangsu Excellence Medical Supplies Co., Ltd

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Disposable Face Mask is 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
    The proposed device, Disposable Face Mask is a three-layer, single-use, flat-pleated mask. The ear loops to secure the mask over the users' mouth and face and includes a nosepiece to provide a firm fit over the nose. The disposable surgical mask is available in four different specifications: 14.5cmx9.5cm and 17.5cmx9.5cm. The device is single use and provided non-sterile.
    Ask a Question

    Ask a specific question about this device

    K Number
    K201324
    Device Name
    Antibacterial Bandage
    Date Cleared
    2021-02-05

    (263 days)

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

    Jiangsu Excellence Medical Supplies Co., Ltd

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Antibacterial bandage is to be applied topically to the skin for management of minor scrapes and minor burns. Antibacterial bandage is to be applied topically to the skin for management of minor cuts, minor scrapes and minor burns.
    Device Description
    The device, Antibacterial bandage, is to be applied topically to the skin for management of minor cuts, minor scrapes and minor burns. The proposed devices are available in fabric backing and plastic backing. All of devices consist of (1) backing (fabric or plastic), (2) absorbent pad (composed of Polyester fiber, viscose fiber, PE mesh, Benzalkonium chloride) and (3) release paper (composed of cellulose pulp, water, kaolin, starch, ethanol and ethylene copolymer). Each device type is available in several models. The difference between each model is the device size. This dressing contains 0.08% benzalkonium chloride which has shown effectiveness against (Staphylococcus Aureus, Pseudomonas Aeruginosa, Escherlchia coli, Enterococcus Faecalis, Klebsiella Pneumoniae, Streptococcus Pyogenes, Candida Albicans and Aspergillus Niger) for up to 24 hours, as demonstrated via in vitro testing.
    Ask a Question

    Ask a specific question about this device

    Page 1 of 1