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510(k) Data Aggregation

    K Number
    K210878
    Device Name
    Surgical Face Mask (Model: CM2006, CM2008, A88)
    Manufacturer
    Shenzhen RealTone Medical Appliance Co., Ltd.
    Date Cleared
    2021-09-28

    (188 days)

    Product Code
    FXX
    Regulation Number
    878.4040
    Type
    Traditional
    Panel
    General Hospital
    Reference & Predicate Devices
    K200847
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    Surgical Face Mask is intended for single use by operating room personnel and other general healthcare workers to protect both patients and healthcare workers against transfer of microorganisms, body fluids, and particulate materials.

    Device Description

    Surgical Face Mask is a non-sterile, single use multi-layer mask with outer layer and inner layer (spun-bond polypropylene) that sandwich a meltblown polypropylene filter material. There are 2 options for the Surgical Face Mask to be secured on user via earloops (model CM2006 and A88) or ties (model CM2008). Earloops are of Chinlon+Spandex Elastic Fiber (model CM2006) and polyester fibre (model A88) and not made with natural rubber latex; and ties are of spun-bond polypropylene and also not made with natural rubber latex. The nose piece is a single galvanize wire, coated by Polyethylene (model CM2006 and CM2008) and aluminum (model A88). All of the materials used in the construction of the surgical face mask are being used in currently marketed devices.

    AI/ML Overview

    The provided text describes a 510(k) submission for a Surgical Face Mask and outlines the performance criteria and testing conducted to demonstrate substantial equivalence to a predicate device. This is a medical device submission, not an AI/ML product, so the questions regarding AI/ML-specific criteria (like effect size of AI assistance, AI-only performance, training set details) are not applicable.

    Here's a breakdown of the requested information based on the provided document:

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

    Test MethodologyPurposeAcceptance CriteriaReported Device Performance
    Fluid Resistance ASTM F1862-17To evaluate the effectiveness of the test article in protecting the user from possible exposure to body fluids.No penetration pass at 160mmHgPass, no penetration pass at 160mmHg.
    Particulate Filtration Efficiency ASTM F2299-17To evaluate the effectiveness of the test article in protecting the user from possible exposure to particulates.≥98%Pass, CM2006 and CM2008: Average 99.88%; A88: Average 99.56%
    Bacterial Filtration Efficiency ASTM F2101-19To evaluate the bacterial filtration efficiency (BFE) of mask.≥98%Pass, CM2006 and CM2008: Average 99.88%; A88: Average 99.9%
    Differential Pressure (Delta P) EN 14683:2019, Annex C and ASTM F2100-19To measure the differential pressure of mask which is related to breathability.
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