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510(k) Data Aggregation

    K Number
    K210643
    Device Name
    Disposable Surgical Face Mask
    Manufacturer
    Shandong Zhushi Pharmaceutical Group Co., Ltd
    Date Cleared
    2021-08-04

    (154 days)

    Product Code
    FXX
    Regulation Number
    878.4040
    Type
    Traditional
    Panel
    General Hospital
    Reference & Predicate Devices
    K203200
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Disposable Surgical Face Mask is intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids and particulate material. This face 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(s), provided non sterile.

    The Disposable Surgical Face Mask is indicated as a protective nose and mouth covering for healthcare workers and patients involved in medical and surgical procedures. The masks are indicated in any procedure or situation where there is a risk of exposure to microorganisms and body fluids.

    Device Description

    The Disposable Surgical Face Mask is single use, three-layer, flat-pleated style with ear-loop and nose piece. The mask is manufactured with three layers, the inner and outer layers, and the ear-loop is made of spandex and polyester, and the middle layer is made of melt blown fabrics. During use, the ear-loop shall be tied over user ear. The nose piece in the layers of facemask is to allow the user to fit the facemask around their nose, which is made of malleable polyethylene wire. The Disposable Surgical Face Mask is provided in blue color. The mask is sold non-sterile and are intended to be single use, disposable devices.

    AI/ML Overview

    The document describes the acceptance criteria and performance of a "Disposable Surgical Face Mask" (K210643) compared to a predicate device (K203200).

    Here's the requested information:

    1. Table of Acceptance Criteria and Reported Device Performance

    Performance TestAcceptance CriteriaReported Device PerformanceASTM F2100 Level (if applicable)
    Fluid Resistance (ASTM F1862M-17)160 mmHg (Level 3)95 of 96 samples passed at 160mmHgLevel 3
    Particulate Filtration Efficiency (PFE) (ASTM F2299-03)≥98%96/96 samples passed at ≥98%Level 3
    Bacterial Filtration Efficiency (BFE) (ASTM F2101-19)≥98%94/96 samples passed at ≥98%Level 3
    Differential Pressure (EN 14683 Annex C)<6.0 mmH2O/cm²92/96 samples passed at <6 mmH2O/cm²Level 3
    Flammability (16 CFR Part 1610)Class 1 (≥3 seconds burn time)96/96 samples passed at ≥3 seconds burn time - Class 1Class 1
    Cytotoxicity (ISO 10993-5:2009)Non-cytotoxicDevice was non-cytotoxicN/A
    Irritation (ISO 10993-10:2010)Non-irritatingDevice was non-irritatingN/A
    Sensitization (ISO 10993-10:2010)Non-sensitizingDevice was non-sensitizingN/A

    2. Sample Size Used for the Test Set and Data Provenance

    • For the performance tests (Fluid Resistance, PFE, BFE, Differential Pressure, Flammability): 3 lots tested with a total of 96 samples for each test (e.g., 32 samples per lot).
    • Data Provenance: The document does not explicitly state the country of origin of the test data (e.g., whether the tests were conducted in China where the manufacturer is located or another country). It also does not specify if the studies were retrospective or prospective, though performance testing of physical products is generally prospective.

    3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

    • This information is not applicable as the document describes performance testing of a physical medical device (surgical face mask) against established technical standards, not an AI/software device requiring expert interpretation for ground truth.

    4. Adjudication Method for the Test Set

    • This information is not applicable for the type of testing described (physical product performance against quantitative standards). Pass/fail criteria are defined by the standards themselves.

    5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

    • This information is not applicable as the document describes the performance testing of a physical medical device (surgical face mask), not an AI/software device or a comparative effectiveness study involving human readers.

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

    • This information is not applicable as the document pertains to a physical medical device.

    7. The Type of Ground Truth Used

    • The "ground truth" for the device's performance is based on pre-defined technical standards (e.g., ASTM F2101-19, EN 14683, ASTM F1862M-17, 16 CFR Part 1610, ISO 10993) which specify quantitative measurements and thresholds for acceptable performance. Biocompatibility (cytotoxicity, irritation, sensitization) is also assessed against established biological standards.

    8. The Sample Size for the Training Set

    • This information is not applicable as the document describes performance testing of a physical medical device, which does not involve a training set as used in machine learning or AI.

    9. How the Ground Truth for the Training Set Was Established

    • This information is not applicable as the document does not relate to machine learning or AI and therefore does not have a "training set" or corresponding ground truth establishment process.
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