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    K Number
    K210181
    Device Name
    Nordiwell Surgical Face Mask
    Manufacturer
    Changzhou Combat Protective Equipment Co., Ltd.
    Date Cleared
    2021-03-09

    (46 days)

    Product Code
    FXX
    Regulation Number
    878.4040
    Type
    Special
    Panel
    General Hospital
    Reference & Predicate Devices
    K202615
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    When properly worn, the surgical face masks are intended to patient and healthcare workers from transfer of microorganisms, body fluids and particulate matter. This device is non-sterile and for single use only.

    Device Description

    The Nordiwell Surgical Face Masks are composed of 3-layers and are flat-pleated. The mask materials consist of an outer layer (polypropylene spunbond, blue), inner layer (polypropylene spunbond white), filter (polypropylene melt-blown, white) and ties (polypropylene spunbond white). The mask contains a malleable nosepiece which is centrally positioned between the opposed side edges along the top edge of the mask. The nosepiece is a stable anchor in the vicinity of the nose and readily bent to conform to contours of a person's face. Thus the nosepiece can provide a firm fit over the nose and then to secure the mask over the users' mouth and face. The mask is a single use, provided non-sterile. This device is not made with natural rubber latex and Shelf-life of the device is 2 years. The subject of this submission is a design change to the ear-loop in the Nordiwell Medical Face Mask(K202615). The ear-loop of the Nordiwell Medical Face Mask(K202615) is changed to tie in the subject device.

    AI/ML Overview

    This document describes the acceptance criteria and supporting study for the Nordiwell Surgical Face Mask (K210181), which is a surgical face mask.

    1. Table of Acceptance Criteria and Reported Device Performance

    The device is evaluated against the ASTM F2100 Level 3 standard for surgical face masks.

    Performance CharacteristicAcceptance Criteria (ASTM F2100 Level 3)Reported Device Performance
    Fluid Resistance160 mmHg32 of 32 pass at 160 mmHg
    Particulate Filtration Efficiency (PFE)≥ 98% at 0.1 micron> 99.9%
    Bacterial Filtration Efficiency (BFE)≥ 98%≥ 98%
    Differential Pressure (Delta P)**
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