Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K111559
    Device Name
    SURGICAL MASKS
    Manufacturer
    SHANGHAI NEO-MEDICAL IMPORT & EXPORT CO., LTD.
    Date Cleared
    2011-09-16

    (102 days)

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

    **SHANGHAI NEO-MEDICAL IMPORT **& EXPORT CO

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Surgical Masks are indicated as a protective nose and mouth covering for healthcare workers and patients involved in medical and surgical procedures. The masks are indicated in any procedure or situation where there is a risk of microorganism, body fluid.
    Device Description
    The Surgical Masks are indicated as a protective nose and mouth covering for healthcare workers and patients involved in medical and surgical procedures. The masks are indicated in any procedure or situation where there is a risk of microorganism, body fluid. The proposed devices are available in four models with same mask (3-ply) and different configurations, such as ear loop, tie on, eye shield and foam. Detail configurations of them are presented in Table V-1 Surgical Masks Description. All of the proposed devices are non-sterile, and only for single use.
    Ask a Question

    Page 1 of 1