LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K220550
    Device Name
    Disposable Surgical Face Mask (M663BE, M663BT)
    Manufacturer
    MAKRITE INDUSTRIES, INC.
    Date Cleared
    2022-06-14

    (109 days)

    Product Code
    FXX
    Regulation Number
    878.4040
    Type
    Traditional
    Panel
    General Hospital
    Reference & Predicate Devices
    K210433
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Disposable Surgical Face Masks are intended to be worn to protect both the patient and healthcare personnel from transferring 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 Disposable Surgical Face Mask is blue color, single use, flat-folded masks with nose piece and ear loops or ties. The blue colorant is polypropylene (PP) master batch.

    The body of the mask is composed of four layers: the inner(4th layer) and outer(1st layers are made of spun-bond polypropylene, the 2nd layer is made of polyethylene film and the 3rd layer is made of melt blown polypropylene. The nose piece is made of Iron core coated with polypropylene, ear loop is made of Nylon and Spandex, and the ties are made of spun-bond polypropylene. Each mask contains ear loops or ties to secure the mask over the user's face and mouth with a bendable nose piece to firmly fit over the nose. This device is not made with natural rubber latex. The disposable surgical face masks are sold non-sterile and are intended to be single use, disposable devices.

    AI/ML Overview

    The provided FDA 510(k) summary describes the acceptance criteria and the study results for the Disposable Surgical Face Mask (M663BE, M663BT).

    Here's a breakdown of the requested information:

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

    Test MethodologyPurposeAcceptance CriteriaReported Device Performance
    Fluid Resistance (ASTM F1862)To demonstrate resistance to penetration by synthetic blood.ASTM F2100 Level 3
    29 out of 32 pass at 160 mmHg for Level 3Pass
    32 out of 32 pass at 160 mmHg, 3 lots
    Particulate Filtration Efficiency (ASTM F2299)To demonstrate the functionality of the subject device.≥ 98%Pass
    Average 99.929%, 99.947%, 99.978%
    Bacterial Filtration Efficiency (ASTM F2101)To demonstrate the functionality of the subject device.≥ 98%Pass
    Average 99.8%, 99.9%, 99.8%
    Differential Pressure (EN 14683 Annex C)To demonstrate the functionality of the subject device.
    Ask a Question

    Ask a specific question about this device

    Page 1 of 1