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510(k) Data Aggregation

    K Number
    K212375
    Device Name
    Disposable Medical Surgical Mask
    Manufacturer
    Jiangxi Bestgrand Health Technology Co., Ltd.
    Date Cleared
    2022-01-04

    (158 days)

    Product Code
    FXX
    Regulation Number
    878.4040
    Type
    Traditional
    Panel
    General Hospital
    Reference & Predicate Devices
    K100846
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Disposable Medical Surgical 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 a single use, disposable device(s), provided sterile.

    Device Description

    The Disposable Medical Surgical Mask is composed of mask body, nose clip and ear loop. The body of the mask is composed of three layers: the inner and outer layers are made of Spun-bond polypropylene, and the middle layer is made of melt blown polypropylene filter, the nose clip is made of plastic materials and iron wire, ear loop is made of spandex.

    The size of the Disposable Medical Surgical Mask is 17.5*9.5cm with tolerance +/- 0.2cm, the length of the ear loop is 17cm with tolerance +/-5 cm, and the length of the nose clip should no less than 8.0cm.

    The outer layer of Disposable Medical Surgical Mask will be provided in blue, the inner layer of the Disposable Medical Surgical Mask will be provided in white, and it will be provided with sterile and is intended to be single use, disposable devices.

    AI/ML Overview

    This document describes the premarket notification for a Disposable Medical Surgical Mask. It does not contain information about an AI/ML powered device, so I cannot answer your questions as they pertain to the criteria for AI/ML powered medical devices.

    The document discusses the substantial equivalence of the proposed device to a legally marketed predicate device, focusing on material composition, intended use, and performance characteristics consistent with surgical masks.

    However, I can extract the acceptance criteria and performance results for this non-AI medical device.

    1. A table of acceptance criteria and the reported device performance

    ItemProposed deviceAcceptance Criteria (level 2)Result
    Fluid Resistance Performance
    ASTM F186232 out of 32 pass at
    120 mmHg29 out of 32 pass at 120 mmHgPASS
    Particulate Filtration Efficiency
    ASTM F229999.9%≥ 98%PASS
    Bacterial Filtration Efficiency
    ASTM F210199.9%≥ 98%PASS
    Differential Pressure (Delta P)
    EN 14683 Annex C3.26 mmH2O/cm²
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