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510(k) Data Aggregation

    K Number
    K213806
    Device Name
    Disposable Medical Face Mask
    Manufacturer
    Xiantao Zhibo Nonwoven Products Co., Ltd
    Date Cleared
    2022-03-12

    (96 days)

    Product Code
    FXX
    Regulation Number
    878.4040
    Type
    Traditional
    Panel
    General Hospital
    Reference & Predicate Devices
    K211827
    Why did this record match?
    Applicant Name (Manufacturer) :

    Xiantao Zhibo Nonwoven Products Co., Ltd

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

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

    Device Description

    Disposable Medical Face Mask is composed of Nylon & Spandex Ear loops, High Density Polyethylene nose clip, Inner layer Non-woven fabric, Middle Melt-blown Non-woven fabric and outer Non-woven fabric. The melt-blown material acts as the filter that stops microbes from entering or exiting the mask. Disposable Medical Face Mask feature pleats. Three pleats are used to expand the mask such that it covers the area from the nose to the chin. The type is ear loop, where a string-like material is attached to the mask and placed behind the ears. The proposed device(s) are sold non-sterile and are intended to be single use, disposable device.

    AI/ML Overview

    The provided document is a 510(k) premarket notification for a Disposable Medical Face Mask. It focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study of an AI-powered medical device. Therefore, most of the requested information about an AI-powered device, such as MRMC studies, training set details, or expert ground truth establishment, is not applicable to this document.

    However, I can extract the acceptance criteria and performance data for the physical properties of the face mask as tested.

    Here's the relevant information based on the provided document:

    1. Table of Acceptance Criteria and Reported Device Performance

    ItemPurposeProposed Device (Reported Performance)Acceptance CriteriaResult
    Fluid Resistance ASTM F1862Assess the performance of a mask to resistance to a synthetic blood preparation targeted toward the mask at a set pressure32 out of 32 pass at 160 mmHg (across 3 lots)29 out of 32 pass at 160 mmHg for level 3PASS
    Particulate Filtration Efficiency ASTM F2299Assess the performance of a mask to penetration by sub-micron polystyrene latex particles of 0.1 micronLot1: 98.9%, Lot2: 99.3%, Lot3: 99.5 %≥ 98%PASS
    Bacterial Filtration Efficiency ASTM F2101Assess the performance of a mask to penetration by a prepared solution with known concentration of an indicator bacterial organismLot1: 99.88%, Lot2: 99.95%, Lot3: 99.97%≥ 98%PASS
    Differential Pressure (Delta P) EN 14683 Annex CAssess the performance of a mask for resistance to air movement through the materials of the face of the maskLot1: 3.3 H2O/cm², Lot2: 3.4 H2O/cm², Lot3: 3.3 H₂O/cm²
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