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510(k) Data Aggregation

    K Number
    K211861
    Device Name
    TAIJI Professional Series Level 3 Surgical Face Mask
    Manufacturer
    Taiji Medical Supplies, Inc.
    Date Cleared
    2021-07-28

    (42 days)

    Product Code
    FXX
    Regulation Number
    878.4040
    Type
    Abbreviated
    Panel
    General Hospital
    Reference & Predicate Devices
    K202595
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The TAIJI Professional Series Level 3 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. These face intended for use in infection control practices to reduce the potential exposure to blood and body fluid. This is a single use, disposable device, provided non-sterile.

    Device Description

    The TAIJI Professional Series Level 3 Surgical Face Mask is a flat-pleated style mask with elastic ear loops to secure it over the users' mouth and face. The mask consists of three-layers. The inner facing layer is white and is manufactured from spunbond polypropylene (three layers of nonwoven polypropylene). The inner filter material is made of meltblown fiber. The outer facing layer is blue and is manufactured from spunbond polypropylene (three layers of nonwoven polypropylene). The mask is a single use, disposable device, provided nonsterile.

    AI/ML Overview

    This document pertains to the 510(k) premarket notification for a medical device: TAIJI Professional Series Level 3 Surgical Face Mask (K211861).

    The acceptance criteria and study proving the device meets these criteria are outlined in the "Summary of Non-Clinical Testing" section.

    Here's the breakdown of the information requested, based on the provided document:

    1. Table of Acceptance Criteria and Reported Device Performance

    Standard/Test MethodologyPurposeAcceptance CriteriaReported Device Performance
    ASTM F1862: Standard Test Method for Resistance of Medical Face Masks to Penetration by Synthetic BloodBarrier TestingAt least 29 out of 32 specimens show passing results at 160 mmHgSamples met the predetermined acceptance criteria.
    ASTM F2101-19: Standard Specification for Performance of Materials Used in Medical Face MasksBarrier Testing≥98%Samples met the predetermined acceptance criteria (96 Samples, 3 non-consecutive lots of 32 each).
    EN 14683:2019 Annex C and ASTM F2100-19: Standard Specification for Performance of Materials Used in Medical Face MasksPhysical Testing
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