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510(k) Data Aggregation

    K Number
    K202211
    Device Name
    Disposable Medical Surgical Face Masks
    Manufacturer
    Guangdong Kaidi Garments Co.,Ltd
    Date Cleared
    2020-12-22

    (138 days)

    Product Code
    FXX
    Regulation Number
    878.4040
    Type
    Traditional
    Panel
    General Hospital
    Reference & Predicate Devices
    K153496
    Predicate For
    K203078,K210815,K220487
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Disposable Medical Surgical Face Masks are 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 is a single use, disposable device(s), provided non-sterile.

    Device Description

    The Disposable Medical Surgical Face Masks are 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 nonwoven fabric, and the middle layer is made of melt blown non-woven fabric. The nose clip is made of PE and iron wire, ear loop is made of Nylon and Spandex. The size of the disposable surgical mask is 17.5*9.5cm with tolerance±1cm, the length of the ear loop is 18cm. The outer layer of disposable surgical mask will be provided in blue, the inner layer of the disposable surgical mask will be provided in white, and it will be provided with non-sterile and is intended to be single use, disposable devices.

    AI/ML Overview

    The provided document describes the acceptance criteria and study results for Disposable Medical Surgical Face Masks (K202211) manufactured by Guangdong Kaidi Garments Co., Ltd. The study focuses on demonstrating substantial equivalence to a predicate device (K153496) through non-clinical testing.

    Here's the breakdown as requested:

    1. Table of Acceptance Criteria and Reported Device Performance

    ItemAcceptance Criteria (Level 2 Medical Mask)Reported Device Performance (K202211)Result
    Fluid Resistance (ASTM F1862)29 out of 32 Pass at 120 mmHg32 out of 32 per lot pass at 120 mmHg, 3 non-consecutive lots testedPASS
    Particulate Filtration Efficiency (ASTM F2299)≥ 98%Lot 1: 99.68%; Lot 2: 99.56%; Lot 3: 99.81% (3 non-consecutive lots tested)PASS
    Bacterial Filtration Efficiency (ASTM F2101)≥ 98%Lot 1: 99.9%; Lot 2: 99.9%; Lot 3: 99.9% (3 non-consecutive lots tested)PASS
    Differential Pressure (Delta P) (EN 14683 Annex C)
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