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510(k) Data Aggregation

    K Number
    K223055
    Device Name
    Disposable Medical Face Mask
    Manufacturer
    Xiantao Zhuobo Industrial Co., LTD
    Date Cleared
    2022-12-05

    (67 days)

    Product Code
    FXX
    Regulation Number
    878.4040
    Type
    Traditional
    Panel
    General Hospital
    Reference & Predicate Devices
    K213806
    Why did this record match?
    Applicant Name (Manufacturer) :

    Xiantao Zhuobo Industrial Co., LTD

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

    The Disposable Medical Face Mask is intended to be worn to protect 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 a blue flat-pleated mask, which is worn in the way of earrings and has a nose clip design to fit the mask around the nose. This product is composed of a mask body (three-layer structure: two layers of polypropylene adhesive nonwoven fabric with a layer of polypropylene melt-blown nonwoven fabric in the middle), a nose clip (made of polyethylene) and ear loops (made of polyester + spandex). The nose clip is located in the middle layer of the mask. Ear loops, string-like material, are 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 text describes the acceptance criteria and the results of a study for a Disposable Medical Face Mask (K223055) to demonstrate its substantial equivalence to a predicate device.

    Here's the breakdown of the requested information:

    1. Table of Acceptance Criteria and Reported Device Performance:

    ItemAcceptance CriteriaProposed Device Performance (Reported Result)Result
    Fluid Resistance (ASTM F1862)29 out of 32 pass at 160 mmHg for Level 332 out of 32 pass at 160 mmHg (across 3 non-consecutive lots)PASS
    Particulate Filtration Efficiency (ASTM F2299)≥ 98%Lot1: 99.39%, Lot2: 99.54%, Lot3: 99.37% (across 3 non-consecutive lots)PASS
    Bacterial Filtration Efficiency (ASTM F2101)≥ 98%Lot1: 99.01%, Lot2: 98.94%, Lot3: 99.06% (across 3 non-consecutive lots)PASS
    Differential Pressure (EN 14683 Annex C)
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