Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K212926
    Device Name
    AllureTM Surgical Mask
    Date Cleared
    2022-09-16

    (367 days)

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

    Allure Gift Wraps Private Limited

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    ALLURETM Surgical 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(s), provided non-sterile.
    Device Description
    ALLURE™ Surgical mask is valve less, consisting of 5 layers made up of breathable PP non-woven, hot air insulation cotton, two layers of melt blown fabrics, non-woven fabrics and plastic nose strips and Elastic cord. The device is designed and tested as per its device specific guidance; "Surgical Masks-Premarket Notification 510(k) Submissions".
    Ask a Question

    Ask a specific question about this device

    Page 1 of 1