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510(k) Data Aggregation

    K Number
    K213970
    Date Cleared
    2022-01-23

    (34 days)

    Product Code
    Regulation Number
    878.4040
    Reference & Predicate Devices
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The D-Care Surgical Face Mask 3 Ply, D-Care Medical Face Mask 3 Ply are intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids and particulate material. The surgical face masks are intended for use in infection control practices to reduce the potential exposure to blood and body fluids. These are single use, disposable devices, provided non-sterile.

    Device Description

    The subject device is three-layers, flat-pleated masks constructed of nonwoven polypropylene materials, the inner and outer layers are made of polypropylene nonwoven, and the middle layer is made of melt blown polypropylene.
    The subject device is provided with ear loops. Ear loops is made of 80% polyester 20% spandex, not made with natural rubber latex.
    A polypropylene wire nose piece is placed within the binding for comfort and individualized fit, allow the user to fit the facemask around their nose.
    The subject device is provided in blue color. The blue colorant is made of polypropylene master batch.
    This subject device is provided with size 17.5 cm ± 0.5 cm. The subject device is single-use, disposable devices, provided non-sterile.

    AI/ML Overview

    This document describes non-clinical performance and biocompatibility testing for the D-Care Surgical Face Mask 3 Ply and D-Care Medical Face Mask 3 Ply.

    Here's the requested information:

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

    Performance CharacteristicAcceptance CriteriaReported Device Performance
    Fluid Resistance≥29 out of 32 passed in 160 mmHg (Level 3)≥29 out of 32 passed in 160 mmHg (Level 3)
    Particulate Filtration≥98% at 0.1µm≥99% at 0.1µm
    Bacterial Filtration≥98%≥99%
    Differential Pressure
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