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510(k) Data Aggregation

    K Number
    K202605
    Device Name
    Standard Procedure Mask, Standard Surgical Mask
    Manufacturer
    Jiangsu Medplus Non-woven Manufacturer Co., Ltd.
    Date Cleared
    2021-02-10

    (155 days)

    Product Code
    FXX
    Regulation Number
    878.4040
    Type
    Traditional
    Panel
    General Hospital
    Reference & Predicate Devices
    K153496
    Why did this record match?
    Device Name :

    Standard Procedure Mask, Standard Surgical Mask

    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, provided non-sterile.

    Device Description

    The proposed devices, Standard Procedure Mask and Standard Surgical Mask, are a three-layer, singleuse, flat-pleated mask. Both the two masks have the same indications for use. The Standard Procedure Mask is an ear-loop surgical mask, and the Standard Surgical Mask is a tie-on surgical mask. The color of the proposed devices is blue. They are provided in non-sterile.

    AI/ML Overview

    This document describes the performance testing of a medical device, specifically a Standard Procedure Mask and a Standard Surgical Mask, to demonstrate substantial equivalence to a predicate device (K153496) for FDA 510(k) clearance.

    Here's an analysis of the acceptance criteria and the study that proves the device meets them:

    1. Table of Acceptance Criteria and Reported Device Performance

    Name of the Test Methodology / StandardPurposeAcceptance CriteriaReported Device Performance
    Resistance to Penetration by Synthetic BloodTo evaluate the effectiveness of the test sample from possible exposure to blood and other body fluids.No penetration at 120 mmHgPass at 120mmHg
    Bacterial Filtration Efficiency (BFE)To determine the bacterial filtration efficiency (BFE) of the test article.$\ge 98%$Average 98.61%
    Particulate Filtration Efficiency (PFE)To determine the Particle Filtration Efficiency.$\ge 98%$Average 98.58%
    Differential Pressure (Breathability)To determine the differential pressure, indicating how easily one can breathe through the mask.$
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