LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K221957
    Device Name
    Savewo ClassicMASK
    Manufacturer
    Savewo Limited
    Date Cleared
    2022-09-02

    (59 days)

    Product Code
    FXX
    Regulation Number
    878.4040
    Type
    Traditional
    Panel
    General Hospital
    Reference & Predicate Devices
    K200923
    Why did this record match?
    Device Name :

    Savewo ClassicMASK

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    Savewo ClassicMASKs are intended to be worn to protect both patient and healthcare personnel from transfer of microorganisms, body fluids, and particulate material.

    Savewo ClassicMASKs 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) and provided non-sterile.

    Device Description

    Savewo ClassicMASK is a 3-layered mask. The outer layer is made of spunbond polypropylene with white color, the inner layer is made of hydrophilic polypropylene/polyethylene non-woven fabric, and the middle layer with filtration function is made of melt-blown polypropylene. The mask contains ear loops to secure the mask over the users' mouth and face and the metal nose strip over the top edge which secures the mask to stay firmly in place. Savewo ClassicMASK is single use, disposable, non-sterile and ASTM Level 3 certified.

    AI/ML Overview

    Here's an analysis of the acceptance criteria and study detailed in the provided document for the Savewo ClassicMASK:

    Description of the Acceptance Criteria and Study

    The Savewo ClassicMASK is a 3-layered surgical mask intended to protect both patient and healthcare personnel from the transfer of microorganisms, body fluids, and particulate material. The device underwent non-clinical testing to demonstrate its performance against established standards, specifically the ASTM F2100-19 standard for Level 3 surgical masks, and to ensure biocompatibility and flammability compliance. The study aims to prove substantial equivalence to a predicate device (Single-use Surgical Mask, K200923) by meeting the outlined acceptance criteria for various performance characteristics.

    1. Table of Acceptance Criteria and Reported Device Performance

    ItemTest Method/StandardAcceptance CriteriaReported Device Performance
    Biocompatibility
    CytotoxicityISO 10993-5:2009 - Biological Evaluation of Medical Devices -- Part 5: Tests for in Vitro CytotoxicityNon-CytotoxicPass (Non-Cytotoxic)
    SensitizationISO 10993-10:2010 - Biological Evaluation of Medical Devices -- Part 10: Tests for Irritation and Skin SensitizationNon-sensitizingPass (Non-sensitizing)
    IrritationISO 10993-10:2010 - Biological Evaluation of Medical Devices -- Part 10: Tests for Irritation and Skin SensitizationNon-irritatingPass (Non-irritating)
    Performance Tests
    Bacterial filtration efficiency (BFE) (%)ASTM F2101-19 - Standard Test Method for Evaluating the Bacterial Filtration Efficiency (BFE) of Medical Face Mask Materials, Using a Biological Aerosol of Staphylococcus aureusPassed at ≥98%Lot 1: ≥99.9%, Lot 2: ≥99.9%, Lot 3: ≥99.9%
    Particulate filtration efficiency (PFE) (%)ASTM F2299/F2299M-03 - Standard Test Method for Determining the Initial Efficiency of Materials Used in Medical Face Masks to Penetration by Particulates Using Latex SpheresPass at ≥98%Lot 1: ≥99.6%, Lot 2: ≥99.7%, Lot 3: ≥99.7%
    Differential pressure (mmH2O/cm²)MIL-M-36945C, Military Specifications: Surgical Mask, disposablePassed at
    Ask a Question

    Ask a specific question about this device

    Page 1 of 1