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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: <5.0 mmH2O/cm² Level 3: <6.0 mmH2O/cm²Pass Level 1: Average 3.68 mmH2O/cm² Level 3: Average 3.97 mmH2O/cm²
    Flammability (16 CFR 1610)To evaluate the flammability of the mask.Class 1Pass, Class 1
    In vitro cytotoxicity (ISO 10993-5)To evaluate the biological safety of the product which has direct contact with intact skin.The test article should not have potential toxicity to L-929 in the MTT method.Pass. Under the conditions of this study, the test article has no potential toxicity to L-929 cells.
    Skin sensitization (ISO 10993-10)To evaluate the biological safety of the product which has direct contact with intact skin.The test article should not cause delayed dermal contact sensitization in the guinea pig.Pass. The test article showed no evidence of causing delayed dermal contact sensitization in the guinea pig.
    Skin irritation (ISO 10993-10)To evaluate the biological safety of the product which has direct contact with intact skin.The irritation response category in the rabbit should be negligible.Pass. The test article has no skin irritation on rabbits.

    2. Sample size used for the test set and the data provenance

    • Fluid Resistance:
      • For ZKM-U02 (Black) and ZKM-U05 (Black): Not explicitly stated, but implies passing for all samples tested.
      • For ZKM-U03 (Blue), ZKM-U04 (White), ZKM-U06 (Blue), ZKM-U07 (White): 32 samples were tested for each model, with 31 out of 32 passing based on the acceptance criteria.
    • Other performance tests (Particulate Filtration Efficiency, Bacterial Filtration Efficiency, Differential Pressure, Flammability): The sample size for these tests is not explicitly stated in the provided text. The results are reported as overall percentages or averages.
    • Biocompatibility tests (Cytotoxicity, Skin Sensitization, Skin Irritation): Sample sizes are not explicitly stated for these tests, though they typically involve a specific number of cells (cytotoxicity) or animals (sensitization/irritation).
    • Data Provenance: The study is "non-clinical" and likely conducted in a laboratory setting. The country of origin for the data is not specified beyond the manufacturer's location in Guangzhou, China. The studies are assumed to be prospective tests performed on the manufactured devices.

    3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

    Not applicable. This is not a study requiring expert interpretation of results to establish ground truth (e.g., medical imaging diagnosis). The ground truth is established by objective measurements against standardized test methodologies (e.g., ASTM, ISO).

    4. Adjudication method for the test set

    Not applicable. There's no human interpretation or subjective assessment that would require an adjudication method. The tests are objective measurements.

    5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and the effect size of how much human readers improve with AI vs without AI assistance

    Not applicable. This device is a medical surgical mask, not an AI-powered diagnostic or assistive tool.

    6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done

    Not applicable. This device is a physical product, not an algorithm.

    7. The type of ground truth used

    The ground truth is based on objective measurements against established international and national standards and methodologies, such as ASTM F1862-17 for fluid resistance, ASTM F2299-17 for particulate filtration efficiency, ASTM F2101-19 for bacterial filtration efficiency, EN 14683:2019+AC:2019 Annex C for differential pressure, 16 CFR 1610 for flammability, and ISO 10993 series for biocompatibility.

    8. The sample size for the training set

    Not applicable. This is not a machine learning or AI device that requires a training set.

    9. How the ground truth for the training set was established

    Not applicable. There is no training set for this device.

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