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510(k) Data Aggregation

    K Number
    K211773
    Device Name
    Single-use Surgical Mask
    Manufacturer
    Taiwan Seafood and Fish Corporation
    Date Cleared
    2021-12-02

    (177 days)

    Product Code
    FXX,REG
    Regulation Number
    878.4040
    Type
    Traditional
    Panel
    General Hospital
    Reference & Predicate Devices
    K202824
    Predicate For
    N/A
    Why did this record match?
    Reference Devices :

    K202824

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Single Use Surgical Mask is intended to be worn to protect both the patient and healthcare personnel from the transfer of microorganisms, body fluids, and particulate material. This is a single use device provided non-sterile.

    Device Description

    The Single-Use Surgical Mask is a 3-ply, disposable surgical face mask. The outer and inner layers of the mask are made of spunbond polypropylene, while the middle layer consists of a meltblown polypropylene filter fabric. The device is secured on the user's face via elastic earloops and are labeled non-sterile, single-use, and disposable. This device is a surface device intended to come in contact with intact skin for a duration of less than 24 hours.

    AI/ML Overview

    The provided document describes the acceptance criteria and the study that proves the performance of a Single-Use Surgical Mask (K211773). This is a non-clinical study, as stated in section 8. Clinical Testing.

    Here's a breakdown of the requested information:

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

    Item/Test MethodPurposeAcceptance CriteriaReported Device Performance (Result)
    Fluid Resistance (ASTM 1862)Demonstrate resistance to fluid sprayPass at 80 mmHg (level 1 fluid resistance)Pass
    Bacterial Filtration Eff. (ASTM F2101-19)Demonstrate resistance to bacterial penetrationPass at ≥ 99%Pass
    Particulate Filtration Eff. (ASTM F2299)Demonstrate resistance to penetration of particulate matterPass at ≥ 95%Pass
    Differential Pressure (EN 14683)Demonstrate breathabilityPass at
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