LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K210840
    Device Name
    Disposable Surgical Mask
    Manufacturer
    Safeway Industry Healthcare.
    Date Cleared
    2021-06-22

    (92 days)

    Product Code
    FXX,DAT
    Regulation Number
    878.4040
    Type
    Traditional
    Panel
    General Hospital
    Reference & Predicate Devices
    K153496
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Disposable 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

    The proposed device(s) are blue color, and flat pleated type mask, utilizing ear loops way for wearing, and they all has nose clips design for fitting the face mask around the nose. The proposed device(s) are manufactured with three layers, the inner and outer layers are made of spun-bond polypropylene, and the middle layer is made of melt blown polypropylene filter. The model of proposed device, ear loops, is held in place over the users' mouth and nose by two elastic ear loops welded to the face mask. The elastic ear loops are made of Spandex and polyester fiber. The nose piece contained in the proposed device(s) is in the layers of face mask to allow the user to fit the face mask around their nose, which is made of polypropylene (PP) and iron wire. The proposed device(s) are sold non-sterile and are intended to be single use, disposable device.

    AI/ML Overview

    The document describes the acceptance criteria and performance of the Disposable Surgical Mask device by Safeway Industry Healthcare.

    Here's the breakdown of the information requested:

    1. A table of acceptance criteria and the reported device performance:

    Test MethodologyAcceptance Criteria (Level 2)Acceptance Criteria (Level 3)Reported Device Performance (Proposed Device)Result
    Fluid Resistance (ASTM F1862)29 out of 32 Pass at 120 mmHg29 out of 32 Pass at 160 mmHg32 out of 32 Pass at 120 mmHg; 32 out of 32 Pass at 160 mmHg; 3 non-consecutive lots (Lot1, Lot2, Lot3)PASS
    Particulate Filtration Efficiency (ASTM F2299)≥ 98%≥ 98%Lot1: 99.1%; Lot2: 98.4%; Lot3: 98.7%PASS
    Bacterial Filtration Efficiency (ASTM F2101)≥ 98%≥ 98%Lot1: 99.9%; Lot2: 99.8%; Lot3: 99.9%PASS
    Differential Pressure (Delta P) (EN 14683 Annex C)
    Ask a Question

    Ask a specific question about this device

    Page 1 of 1