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510(k) Data Aggregation

    K Number
    K202650
    Device Name
    Medical disposable face mask non sterile
    Manufacturer
    Guangdong Zhong Ling Industrial Group Co., Ltd.
    Date Cleared
    2021-03-24

    (191 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 device 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 Medical disposable face mask non sterile is single use, three-layer, flat-folded masks with ear loops and nose piece. The Medical disposable face mask non sterile is 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 outer non-woven cloth is blue and is dyed by colorant of Reactive Blue 2, and the inner non-woven cloth is white and is not dyed by colorant. 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 malleable polyethylene wire. The Medical disposable face mask non sterile will be provided in blue. The Medical disposable face mask non sterile is sold non-sterile and are intended to be single use, disposable devices.

    AI/ML Overview

    Here's an analysis of the acceptance criteria and the study proving the device meets them, based on the provided text:

    1. Table of Acceptance Criteria and Reported Device Performance

    ItemAcceptance CriteriaReported Device Performance
    Fluid Resistance ASTM F186229 out of 32 pass at 120mmHg3 batches, synthetic blood penetration of 32 test articles per each batch is none seen at 120mmHg test pressure. (This means 32 out of 32 passed for each of the 3 batches, exceeding the 29 out of 32 acceptance criteria)
    Particulate Filtration Efficiency ASTM F2299Level 2 ≥ 98%3 batches, average PFE of 32 test articles per each batch: >99.986%, >99.986%, >99.982%; standard deviation: 0.0123, 0.0142, 0.0389. (All results are significantly higher than the 98% acceptance criteria.)
    Bacterial Filtration Efficiency ASTM F2101Level 2 ≥ 98%3 batches, BFE of 32 test articles per each batch: >99.9%, >99.9%, >99.9%. (All results are significantly higher than the 98% acceptance criteria.)
    Differential Pressure (Delta P) EN 14683:2019+AC:2019 Annex C, Flow rate 8 L/minLevel 2 98%", "
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