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510(k) Data Aggregation

    K Number
    K211255
    Device Name
    Surgical Mask
    Manufacturer
    Tianchang Kanghui Protective Products CO LTD
    Date Cleared
    2021-08-28

    (124 days)

    Product Code
    FXX
    Regulation Number
    878.4040
    Type
    Traditional
    Panel
    General Hospital
    Reference & Predicate Devices
    K203685
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Surgical Mask (model: KH8001& KH8002) is intended to be worn to protect both the patient and healtheare personnel from transfer of microorganisms, body fluids and particulate material. These face 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 proposed devices (model: KH8001& KH8002) are White 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 devices are manufactured with three layers, the inner and outer layers are made of spun-bond polypropylene, and the middle layer is made of melt blown polypropylene filter. 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 fiber and spandex. The nose piece in the proposed devices is made of Galvanized wire with polypropylene and is contained within the layers of face mask to allow the user to fit the face mask around their nose. The proposed devices are sold non-sterile and are intended to be single use, disposable devices.

    AI/ML Overview

    This document is a 510(k) premarket notification for a Surgical Mask (models KH8001 & KH8002). The submission aims to demonstrate substantial equivalence to a legally marketed predicate device. The information provided focuses on the physical and performance characteristics of the surgical mask, not an AI/ML powered medical device. Therefore, many of the requested fields related to AI/ML device studies are not applicable.

    Here's the breakdown based on the provided text:

    1. Table of Acceptance Criteria and Reported Device Performance

    Test CharacteristicAcceptance Criteria (ASTM F2100-19 for Level 2 & 3)Reported Device Performance (KH8001 & KH8002)
    Bacterial Filtration Efficiency≥ 98%Level 3: 99.8%
    Level 2: 99.9%
    Particulate Filtration Efficiency≥ 98%Level 3: 99.5%
    Level 2: 99.6%
    Fluid ResistanceLevel 3: 29 out of 32 pass at 160 mmHg
    Level 2: 29 out of 32 pass at 120 mmHgLevel 3: 32 out of 32 passed at 160 mmHg
    Level 2: 32 out of 32 passed at 120 mmHg
    Differential Pressure (Delta P)
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