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510(k) Data Aggregation

    K Number
    K202647
    Device Name
    Surgical Mask
    Manufacturer
    Ningbo Green Textile Co., Ltd.
    Date Cleared
    2021-04-26

    (227 days)

    Product Code
    FXX
    Regulation Number
    878.4040
    Type
    Traditional
    Panel
    General Hospital
    Reference & Predicate Devices
    K182515
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Surgical 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. This is a single use, disposable device(s), provided non-sterile.

    Device Description

    The Surgical Masks are single use, three-layer, flat-pleated style with ear loops and nose piece. The Surgical Masks are manufactured with three layers, the inner and outer layers are made of spun-bond polypropylene, and the middle layer is made of melt blown polypropylene filter. The ear loops are held in place over the users' mouth and nose by two elastic ear loops welded to the facemask. The elastic ear loops are not made with natural rubber latex. The nose piece in the layers of facemask is to allow the user to fit the facemask around their nose, which is made of Polyvinyl chloride coated iron wire. The surqical masks will be provided in blue. The surqical masks are sold non-sterile and are intended to be single use, disposable devices.

    AI/ML Overview

    The provided document is a 510(k) Pre-Market Notification for a Surgical Mask (K202647). It does not include information about AI/ML device performance or clinical studies in humans.

    This document describes the performance of a physical medical device (a surgical mask) against established standards. The questions you've asked are typically relevant for AI/ML-powered medical devices that analyze medical images or data.

    Therefore, many of your questions, such as those related to "AI," "human readers," "effect size," "training set," and "ground truth for training set," are not applicable to the content of this document.

    However, I can extract the relevant information regarding the surgical mask's acceptance criteria and the study that proves it meets those criteria.

    Acceptance Criteria and Device Performance for Surgical Mask (K202647)

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

    Test Method (Standard)Acceptance CriteriaReported Device PerformanceResult
    Fluid Resistance (ASTM F1862)29 out of 32 pass at 120 mmHg (16.0 kPa)31 out of 32 pass at 120 mmHg (16.0 kPa)Pass
    Particulate Filtration Efficiency (ASTM F2299)≥ 98%Average 99.6%Pass
    Bacterial Filtration Efficiency (ASTM F2101)≥ 98%Average 99.75%Pass
    Differential Pressure (Delta P) (MILM-36954C)
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