LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K210184
    Device Name
    Wilson Tech Disposable Medical Face Mask
    Manufacturer
    Wilson Tech (International) Limited
    Date Cleared
    2021-09-14

    (232 days)

    Product Code
    FXX
    Regulation Number
    878.4040
    Type
    Traditional
    Panel
    General Hospital
    Reference & Predicate Devices
    K201479
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    Wilson Tech Disposable Medical 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. Wilson Tech Disposable Medical Face Mask is single use, disposable device, provided non-sterile.

    Device Description

    Wilson Tech Disposable Medical Face Mask is composed of three layers and is flat-pleated. The mask materials consist of an outer layer (spun-bond polypropylene), a middle layer, between the outer layer and inner layers (melt-blown polypropylene), and an inner layer (spun-bond polypropylene). Each mask contains ear loops to secure the mask over the users' mouth and face and includes a malleable nose piece made of galvanized iron wire coated with polyethylene to provide a firm fit over the nose.

    AI/ML Overview

    The provided document is a 510(k) premarket notification for a medical device, specifically the Wilson Tech Disposable Medical Face Mask. It details the device's characteristics and its comparison to a predicate device to demonstrate substantial equivalence.

    Here's an analysis of the acceptance criteria and the study that proves the device meets those criteria:

    1. Table of Acceptance Criteria and Reported Device Performance:

    The document includes a detailed table comparing the subject device (Wilson Tech Disposable Medical Face Mask) with the primary predicate device (DemeMASK Surgical Mask - K201479). The key acceptance criteria are based on surgical mask performance standards, primarily ASTM F2100 Level 3.

    Test MethodologyPurpose of the testAcceptance criteriaTest Results (Wilson Tech Disposable Medical Face Mask)
    Bacterial Filtration Efficiency (BFE)Performed in accordance with ASTM F2101 to determine the bacterial filtration efficiency using a biological aerosol of Staphylococcus aureus.Level 3: ≥98%32/32 Passed at ≥99.3%
    Particulate Filtration Efficiency (PFE)Performed in accordance with ASTM F2299 to determine the particle filtration efficiency using latex spheres.Level 3: ≥98%32/32 Passed at ≥99.28%
    Differential Pressure (delta-P)Performed in accordance with MIL-M-36954C. Measures the breathability of the mask.
    Ask a Question

    Ask a specific question about this device

    Page 1 of 1