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510(k) Data Aggregation

    K Number
    K212574
    Device Name
    Surgical Face Mask
    Manufacturer
    Xiantao Deming Healthcare products Co., Ltd
    Date Cleared
    2021-12-14

    (120 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 intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids and particulate material. They are 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 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 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 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 (PP) and iron wire. The proposed device(s) are sold non-sterile and are intended to be single use, disposable device.

    AI/ML Overview

    Acceptance Criteria and Device Performance for Surgical Face Mask (K212574)

    The provided document describes the acceptance criteria and the results of non-clinical tests performed on the "Surgical Face Mask" (model DM-FM) submitted by Xiantao Deming Healthcare products Co., Ltd. for 510(k) clearance (K212574).

    1. Table of Acceptance Criteria and Reported Device Performance

    ItemAcceptance Criteria: ASTM F2100 Level 2Reported Device Performance (K212574)Result
    Fluid Resistance29 out of 32 pass at 120 mmHg for Level 232 out of 32 pass at 120 mmHg, 3 lotsPASS
    Particulate Filtration Efficiency≥ 98%Min=98.38%; 98.03%; 98.90% (across 3 lots, implied from context)PASS
    Bacterial Filtration Efficiency≥ 98%Min=99.43%; 99.74%; 99.74% (across 3 lots, implied from context)PASS
    Differential Pressure
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