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510(k) Data Aggregation

    K Number
    K222204
    Device Name
    Medical Surgical Mask
    Manufacturer
    Guangzhou ZhengKang Medical Equipment Co.,Ltd
    Date Cleared
    2022-09-23

    (60 days)

    Product Code
    FXX
    Regulation Number
    878.4040
    Type
    Traditional
    Panel
    General Hospital
    Reference & Predicate Devices
    K212293
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    Medical Surgical Mask is intended to be worn to protect both patients and healthcare workers against transfer of microorganisms, body fluids and particulate materials. The Medical Surgical Mask is intended for use in infection control practices to reduce the potential exposure to blood and body fluids. This is a single use, disposable device, provided non-sterile.

    Device Description

    Medical Surgical Mask includes 6 models, which are ZKM-U02 (Black), ZKM-U03 (Blue), ZKM-U04 (White), ZKM-U05 (Black), ZKM-U06 (Blue), ZKM-U07 (White). The Medical Surgical Mask is a non-sterile, single use, three-layer mask with ear loops and nose piece. These 6 models of Medical Surgical Mask share the same structure and they are manufactured with three layers, the outer and inner layers are made of polypropylene non-woven fabric, and the middle layer is made of polypropylene melt spray fabric. The Medical Surgical Mask is held in place over the user's mouth and nose by two ear loops made of polyester textured yarn. The nose piece is made of polyethylene, which allows the users to adjust the nose piece according to the shape of the bridge of the nose.

    AI/ML Overview

    The provided text describes the acceptance criteria and performance of a Medical Surgical Mask but does not involve an AI-powered device or a study comparing AI assistance with human readers. Therefore, the questions related to AI effects, training data, and expert adjudication are not applicable.

    Here's the information that can be extracted:

    1. Table of Acceptance Criteria and Reported Device Performance

    The device, "Medical Surgical Mask," was tested according to various standards (ASTM, EN, CFR, ISO). The results are categorized by Level 1 and Level 3 barrier requirements as per ASTM F2100.

    Test MethodologyPurposeAcceptance CriteriaReported Device Performance
    Fluid Resistance (ASTM F1862-17)To evaluate the effectiveness of the test article in protecting the user from possible exposure to body fluids.Level 1: 80mmHg
    Level 3: 160mmHgZKM-U02 (Black) (Level 1): No penetration at 80mmHg
    ZKM-U03 (Blue) (Level 1): 31 out of 32 pass at 80mmHg
    ZKM-U04 (White) (Level 1): 31 out of 32 pass at 80mmHg
    ZKM-U05 (Black) (Level 3): No penetration at 160mmHg
    ZKM-U06 (Blue) (Level 3): 31 out of 32 pass at 160mmHg
    ZKM-U07 (White) (Level 3): 31 out of 32 pass at 160mmHg
    Particulate Filtration Efficiency (ASTM F2299-17)To evaluate the effectiveness of the test article in protecting the user from possible exposure to particulates.Level 1: ≥95%
    Level 3: ≥98%Pass
    Level 1: ≥96.42%
    Level 3: ≥99.89%
    Bacterial Filtration Efficiency (ASTM F2101-19)To evaluate the bacterial filtration efficiency (BFE) of the mask.Level 1: ≥95%
    Level 3: ≥98%Pass
    Level 1: ≥99.6%
    Level 3: ≥99.8%
    Differential Pressure (Delta P) (EN 14683:2019+AC:2019 Annex C)To measure the differential pressure of mask which is related to breathability.Level 1:
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