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    K Number
    K220824
    Device Name
    Medical Surgical Mask (Planar type)
    Manufacturer
    Hunan Chopard Medical Devices Co., Ltd
    Date Cleared
    2022-05-19

    (59 days)

    Product Code
    FXX
    Regulation Number
    878.4040
    Type
    Traditional
    Panel
    General Hospital
    Reference & Predicate Devices
    K211827
    Why did this record match?
    Device Name :

    Medical Surgical Mask (Planar type)

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

    The 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. The medical surgical mask is 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 non-sterile.

    Device Description

    The Medical Surgical Masks are blue color, three-layer, flat-pleaded masks with nose piece and ear loops, which are composed of inner layer and outer layer. The colorant is blue polypropylene (PP) master batch. The inner layer and outer layer of the mask are made of non-woven fabric (polypropylene), the middle layer is made of melt-blown fabric (polypropylene). The ear loop of the subject mask is held in place over the users' mouth and nose by two ear loops welded to the face mask. The ear loop is made with polyamide and spandex. The nose piece in the layers of face mask is to allow the user to fit the mask around their nose, which is made of polypropylene wrapped galvanized soft wire. The Medical Surgical Mask is sold non-sterile and are intended to be single use, disposable devices. The mask is designed and manufactured in accordance with ASTM F2100-19 Standard Specification for Performance of Materials Used in Medical Face Masks.

    AI/ML Overview

    This document is a 510(k) premarket notification for a Medical Surgical Mask (Planar type). It focuses on demonstrating substantial equivalence to a predicate device, as required by the FDA. The performance data presented is for the device itself, not an AI/ML algorithm. Therefore, many of the requested categories related to AI/ML clinical studies are not applicable.

    Here's a breakdown of the available information:

    1. Table of Acceptance Criteria and Reported Device Performance

    The device is a Medical Surgical Mask, and its performance is evaluated against parameters specified in medical device standards such as ASTM F2100. The acceptance criteria and reported performance are for the physical properties and barrier effectiveness of the mask.

    Test MethodologyPurposeAcceptance Criteria (for Level 3 Barrier)Reported Device Performance (for 3 non-consecutive lots, sample size 32/lot)
    Bacterial Filtration Efficiency (ASTM F2101)Measure bacterial filtration efficiency≥98%Passed: Lot 1: ≥98%, Lot 2: ≥98%, Lot 3: ≥98%
    Differential Pressure (mmH2O/cm²) (EN 14683:2019 Annex C)Determine breathability of the mask
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