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510(k) Data Aggregation

    K Number
    K202314
    Device Name
    Procedure face mask (Model: KKF-2A)
    Manufacturer
    Han Zhaoqing Sporting Goods Company Limited
    Date Cleared
    2021-01-13

    (149 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 Procedure 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 Procedure face mask is a three-layer, flat-pleated style mask with ear loops and nose piece design for fitting the face mask around the nose and mouth. The proposed device is manufactured with three layers, the inner (Layer #3) and outer (Layer #1) layers are made of spun-bond polypropylene, and the middle layer (Filter layer) is made of melt-blown polypropylene. The ear loops are made of Polyester & elastane, and the nose piece is made of Malleable polyethylene wire. The ear loops are held in place over the users' mouth and nose by two elastic ear loops welded to the face mask. 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 face masks will be provided in blue. The face masks are sold non-sterile and are intended to be single-use, disposable devices.

    AI/ML Overview

    This document describes the premarket notification for a procedure face mask (Model: KKF-2A) and its substantial equivalence to a predicate device. The information provided heavily focuses on non-clinical performance testing.

    Here's a breakdown of the requested information based on the provided text:

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

    ItemAcceptance Criteria for Level 2Reported Device PerformanceResult
    Fluid Resistance Performance (mmHg)29 out of 32 pass at 120 mmHgPassed at 120mm HgPASS
    Particulate Filtration Efficiency Performance (%)≥ 98%Passed at 99.8%PASS
    Bacterial Filtration Efficiency Performance (%)≥ 98%Passed at 99.8%PASS
    Differential Pressure (Delta-P) (mm H2O/cm²)
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