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510(k) Data Aggregation

    K Number
    K202794
    Device Name
    Surgical face mask: F-Y1-A
    Manufacturer
    Jiande Chaomei Daily Chemicals Co., Ltd
    Date Cleared
    2021-12-13

    (446 days)

    Product Code
    FXX
    Regulation Number
    878.4040
    Type
    Traditional
    Panel
    General Hospital
    Reference & Predicate Devices
    K182515
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

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

    Device Description

    The Surgical Face Masks are single use, three-layer, flat -folded masks with ear loops and nose piece. The Surgical Face Masks are manufactured with three layers, the inner and outer layers are made of spunbond polypropylene, and the middle layer is made of melt blown polypropylene filter. The ear loops are held in place over the users' mouth and nose by two elastic ear loops welded to the facemask. The elastic ear loops are not made with natural rubber latex. The nose piece in the layers of facemask is to allow the user to fit the facemask around their nose, which is made of PVC wrapped with metal wire. The surgical face masks will be provided in blue. The surgical face masks are sold non-sterile and are intended to be single use, disposable devices.

    AI/ML Overview

    The provided text describes the acceptance criteria and the study results for the "Surgical Face Mask: F-Y1-A".

    1. Table of acceptance criteria and the reported device performance:

    ItemAcceptance CriteriaReported Device Performance
    Fluid Resistance Performance (ASTM F1862)29 out of 32 pass at 120 mmHgPass
    Particulate Filtration Efficiency (ASTM F2299)≥ 98%Lot1: 99.64%, Lot2: 99.70%, Lot3: 99.63% (Pass)
    Bacterial Filtration Efficiency (ASTM F2101)≥ 98%Lot1: 99.6%, Lot2: 99.8%, Lot3: 99.4% (Pass)
    Differential Pressure (Delta P) (MIL-M-36954C)
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