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510(k) Data Aggregation

    K Number
    K230617
    Device Name
    Surgical Face Mask (L 175*95mm)
    Manufacturer
    Henan Chaoya Medical Equipment Co., Ltd.
    Date Cleared
    2023-06-01

    (87 days)

    Product Code
    FXX
    Regulation Number
    878.4040
    Type
    Traditional
    Panel
    General Hospital
    Reference & Predicate Devices
    K221272
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Surgical Face 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 ininfection 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 Proposed device(s) are blue color, and flat pleated type mask, utilizing ear loops way for wearing, and they all has Nose clips design for fitting the face mask around the nose. The proposed device(s) are manufactured with three layers, the inner and outer layers are made of nonwoven fabric (polypropylene), and the middle layer is made of melt blown fabric (polypropylene). The model of proposed device, ear loops, is held in place over the users' mouth and nose by two elastic ear loops welded to the face mask. The elastic ear loops are made of Polyester and Spandex. The nose piece contained in the proposed device(s) is in the layers of face mask to allow the user to fit the face mask around their nose, which is made of polypropylene .iron and zinc. The proposed device(s) are sold nonsterile and are intended to be single use, disposable device.

    AI/ML Overview

    This document describes the acceptance criteria and the study proving that the "Surgical Face Mask (L 175*95mm)" device meets those criteria.

    1. Table of Acceptance Criteria and Reported Device Performance:
    ItemPurposeAcceptance CriteriaReported Device PerformanceResult
    Fluid Resistance ASTM F1862Assess the performance of a mask to resistance to a synthetic blood preparation targeted toward the mask at a set pressure29 out of 32 pass at 120 mmHg for Level 232 out of 32 pass at 120 mmHgPASS
    Particulate Filtration Efficiency ASTM F2299Assess the performance of a mask to penetration by sub-micron polystyrene latex particles of 0.1 micron≥ 98%Lot1: 98.21%, Lot2: 98.21%, Lot3: 98.16%PASS
    Bacterial Filtration Efficiency ASTM F2101Assess the performance of a mask to penetration by a prepared solution with known concentration of an indicator bacterial organism≥ 98%Lot1: 98.21%, Lot2: 98.24%, Lot3: 98.20%PASS
    Differential Pressure (Delta P) EN 14683 Annex CAssess the performance of a mask for resistance to air movement through the materials of the face of the mask
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