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Post-market review of face masks: Outcomes and actions

6 October 2021

The Therapeutic Goods Administration (TGA) is undertaking a post-market review of all face masks included in the Australian Register of Therapeutic Goods (ARTG) to ensure the quality and effectiveness of face masks supplied in Australia, including that they meet the legislative requirements for medical devices, and perform as intended.

For information about the review, including guidance for suppliers and users of face masks, see Post-market review of face masks: Overview.

Our review has identified some face masks are not meeting all the necessary regulatory requirements (e.g. non-conformance with the Essential Principles including labelling, failed TGA laboratory testing) and/or not performing as intended ie. as claimed by the manufacturer. Some masks may pose a risk to public health and safety when used in healthcare settings or industrial / commercial settings where protection from contaminated fluids and airborne particulates is required.

Some masks are being cancelled from the ARTG. Not all face masks that have been cancelled from the ARTG require any further action. For example, there may not be any of those masks remaining in the Australian market.

Depending on the non-conformance identified in our post-market review, some sponsors will be required to recall their face masks or issue a Product Defect Alert or a Product Notification notice that describes the exact nature of the concern / issue so that customers can consider the setting the face mask is being used in, so as to minimise risks associated with its continued use.

Product Defect Alerts or Product Notifications

Face masks subject to a Product Defect Alert or Product Notification are not being physically recalled (or removed from the market). However customers should consider taking a precautionary approach, based on the advice within the defect alert or notification and the setting in which they are being used.

The Product Defect Alerts and Production Notifications provide more detailed information regarding the specific batch/s and ARTG entry for affected face masks.

Product recalls

Some face masks and/or respirators have been identified through testing by our laboratories to present an unreasonable risk of harm to end users due to inconsistencies and/or deficiencies in their Particulate Filtration Efficiency (PFE). PFE measures the efficiency of the respirator to filter fine particles from inhaled air.

Redeployment of these masks away from high-risk healthcare settings and redistribution for use in other high risk, industrial / commercial settings or use to minimise exposure to bushfire smoke / poor air quality may present an unreasonable risk of harm and create a false sense of security for end users in these settings. This is particularly the case for some masks, called respirators that are labelled with claims that cannot be supported (such as providing 95% PFE) and in some instances these masks have a different overall appearance to regular face masks.

As these respirators have no evidence to justify their safe usage where an ‘N95’, ‘P2’ or equivalent respirator is required, the sponsors of these masks will be required to recall (physically remove) these goods permanently from the market.

The TGA will liaise with, among others, the Australian Competition and Consumer Commission and Worksafe Australia about respirators that are not regulated by the TGA to manage any potential risks posed by those respirators in light of the signals from the testing of respirators regulated by the TGA.

For more information about face masks visit Face masks and COVID-19.

Outcomes from the face mask review, including market actions

Displaying 1 - 25 of 203

ARTG number: 109872

Outcome: Product defect alert

Sponsor: Med-Con Pty Ltd

Manufacturer: Med-Con Pty Ltd

Device/Product name: Med-Con Pty Ltd - Surgical Face Masks

Reason

When tested by the TGA, all samples of the device demonstrated inconsistent testing results for fluid resistance at the location of the logo only. Testing confirms the devices offer level 2 or 3 fluid resistance at the main body of the mask in line with the level of fluid resistance claimed.

Comment

All batches of Med-Con facemasks with a "Med-Con" logo on the mask.

ARTG number: 283681

Outcome: Product defect alert

Sponsor: JC Medical Australia

Manufacturer: Henan JoinKona Medical Products

Device/Product name: Mask, surgical, single use

Reason

Insufficient evidence to support claims for bacterial filtration efficiency, differential pressure or splash resistance.

ARTG number: 308620

Outcome: Product defect alert

Sponsor: Omni-Tel Pty Ltd

Manufacturer: Xiantao Tsw Protective Products Co Ltd

Device/Product name: Quovo Mask - Mask, surgical, single use

Reason

 Insufficient evidence to support claims for bacterial filtration efficiency, differential pressure or splash resistance.

ARTG number: 331768

Outcome: No action

Sponsor: Durrenmatt-Folk Trading Pty Ltd

Manufacturer: Fujian Hanhe Nursing Products Co Ltd

Device/Product name: Durrenmatt-Folk Trading Pty Ltd - Airway protection face mask

Comment

TGA review completed, no market action required

ARTG number: 331769

Outcome: Product defect alert

Sponsor: Point Blank Medical Pty Ltd

Manufacturer: Premier Guard Zhongshan Limited

Device/Product name: Point Blank Medical - Premier Guard Facemask - Mask, surgical, single use

Reason

TGA laboratory testing identified that samples of the device failed test(s) for Fluid Resistance.

ARTG number: 331772

Outcome: No action

Sponsor: Telecore Australia Pty Ltd

Manufacturer: Sunsmed Protective Products Ltd

Device/Product name: Mask, surgical, single use

Comment

TGA review completed, no market action required.

ARTG number: 332299

Outcome: Product defect alert

Sponsor: BYD Australia Pty Ltd

Manufacturer: BYD Precision Manufacture Co Ltd

Device/Product name: BYD Care Single use Surgical Mask

Reason

When tested by the TGA, all samples of the device demonstrated inconsistent testing results for fluid resistance at the location of the logo only. Testing confirms the devices offer level 2 fluid resistance at the main body of the mask in line with the level of fluid resistance claimed.

ARTG number: 332563

Outcome: Product defect alert

Sponsor: Tinawells Pty Ltd

Manufacturer: Shandong Zhushi Pharmaceutical

Device/Product name: Mask, surgical, single use

Reason

Insufficient evidence to support claims for bacterial filtration efficiency, differential pressure or splash resistance.

ARTG number: 332682

Outcome: Product defect alert

Sponsor: Jac International Trading

Manufacturer: Xiantao Zhibo Non-woven Products

Device/Product name: Mask, surgical, single use

Reason

Insufficient evidence to support claims for bacterial filtration efficiency, differential pressure or splash resistance.

ARTG number: 332819

Outcome: Product defect alert

Sponsor: DTC Project Imports

Manufacturer: Guangzhou Aiyinmei Co Ltd

Device/Product name: Airway protection face mask

Reason

Insufficient evidence to support claims for bacterial filtration efficiency, differential pressure or splash resistance.

ARTG number: 332835

Outcome: No action

Sponsor: Histar Tradings Pty Ltd

Manufacturer: Henan Yizhong Medical Instrument Co Ltd

Device/Product name: Histar Tradings Pty Ltd - Mask, surgical, single use

Comment

TGA review completed, no market action required

ARTG number: 332844

Outcome: No action

Sponsor: AC Medical Supplies Pty Ltd

Manufacturer: Henan Yizhong Medical Instrument Co Ltd

Device/Product name: Disposable Medical Mask

Comment

TGA review completed, no market action required.

ARTG number: 332850

Outcome: Product defect alert

Sponsor: DTC Project Imports

Manufacturer: Guangzhou Tianyi Zhongliang Biotechnology Group

Device/Product name: Airway protection face mask

Reason

Insufficient evidence to support claims for bacterial filtration efficiency, differential pressure or splash resistance.

ARTG number: 332939

Outcome: Product defect alert

Sponsor: Aster Home Nursing Service Pty Ltd

Manufacturer: Henan Gore Medical Instruments Co Ltd

Device/Product name: Aster Home Nursing Services Facemasks - Mask, surgical, single use

Reason

Insufficient evidence to support claims for bacterial filtration efficiency, differential pressure or splash resistance.

ARTG number: 332989

Outcome: Product defect alert

Sponsor: Lway Trading Pty Ltd

Manufacturer: Henan Yunda Medical Equipment Co Ltd

Device/Product name: Mask, surgical, single use

Reason

Insufficient evidence to support claims for bacterial filtration efficiency, differential pressure, or splash resistance.

ARTG number: 332990

Outcome: Product defect alert

Sponsor: Lway Trading Pty Ltd

Manufacturer: Zhengzhou Ruipu Medical Technology Co Ltd

Device/Product name: Mask, Surgical, Single Use

Reason

Insufficient evidence to support claims for bacterial filtration efficiency, differential pressure, or splash resistance.

ARTG number: 333069

Outcome: No action

Sponsor: The Sydney Cosmetic Specialist Clinic

Manufacturer: Jiang Xi 3L Medical Products Group Co Ltd

Device/Product name: Surgical respirator

Reason

TGA review completed, no market action required

ARTG number: 333081

Outcome: Product defect alert

Sponsor: Biovent Consulting Pty Ltd

Manufacturer: Wuhan ZeruiHealth Gene Technology Co Ltd

Device/Product name: Biovent Consulting - Zerui Face Masks - Mask, surgical, single use

Reason

Insufficient evidence to support claims for bacterial filtration efficiency, differential pressure or splash resistance.

ARTG number: 333092

Outcome: No action

Sponsor: Melbourne Innovation Centre

Manufacturer: Hunan One to Ten Full Chain Medical Technology

Device/Product name: Mask, surgical, single use

Comment

TGA review completed, no market action required.

ARTG number: 333094

Outcome: No action

Sponsor: Melbourne Innovation Centre

Manufacturer: Shantou Jintaishun non-woven Fabric Industry

Device/Product name: Mask, surgical, single use

Comment

TGA review completed, no market action required.

ARTG number: 333095

Outcome: No action

Sponsor: Melbourne Innovation Centre

Manufacturer: Hunan One to Ten Full Chain Medical Technology

Device/Product name: Mask, surgical, single use

Comment

TGA review completed, no market action required.

ARTG number: 333133 (Model: SIMG002)

Outcome: Product defect alert

Sponsor: M House Pty Ltd

Manufacturer: Wuhan Topmed Trading Co

Device/Product name: Softmed disposable face mask

Reason

TGA laboratory testing and post-market review identified inconsistencies in quality control measures, an absence of batch numbers and inconsistent testing results.

ARTG number: 333248

Outcome: No action

Sponsor: Iatric Solutions Pty Ltd

Manufacturer: Xiantao Tongda Non-Woven Products

Device/Product name: Iatric Solutions Pty Ltd - Mask, surgical, single use

Comment

TGA review completed, no market action required

ARTG number: 333249

Outcome: No action

Sponsor: Iatric Solutions Pty Ltd

Manufacturer: Hubei KangNing Protective Products

Device/Product name: Iatric Solutions Pty Ltd - Mask, surgical, single use

Comment

TGA review completed, no market action required

ARTG number: 333367

Outcome: No action

Sponsor: The Sydney Cosmetic Specialist Clinic Pty Ltd

Manufacturer: Jiangyin Medical Devices Co Ltd

Device/Product name: Surgical respirator

Reason

TGA review completed, no market action required

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