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Post-market review of face masks: Outcomes and actions

18 December 2020

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, i.e. 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 issue identified in our post market review, some sponsors will be required to issue a Product Defect Alert or a Product Notification 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.

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 and ARTG entry for affected face masks.

Outcomes from the face mask review, including market actions

Displaying 1 - 9 of 9

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: 332844

Outcome: No action

Sponsor: Apple Pty Ltd

Manufacturer: Fuchen (Shanghai) Clothing Co Ltd

Device/Product name: Supield microporous filter-film mask

Comment

TGA review completed, no market action required.

ARTG number: 332939

Outcome: Product defect alert

Sponsor: Aster Home Nursing Service Pty Ltd

Manufacturer: Henan Gore Medical Instruments Co Ltd

Device/Product name: Mask

Reason

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

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

The results of TGA testing and post-market review indicates systemic failures in quality control measures, an absence of batch numbers and inconsistent testing results.

ARTG number: 333739

Outcome: Product defect alert

Sponsor: Jet Express Group Pty Ltd

Manufacturer: Chengdu Xinjin Shifeng Medical Apparatus & Instruments Co Ltd

Device/Product name: Shifeng Surgical Face Mask

Reason

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

ARTG number: 333778

Outcome: Product notification

Sponsor: De La Fontaine Australia Pty Ltd

Manufacturer: Wuyishan Jiean Medical Device Manufacturing Co Ltd

Device/Product name: Korango Disposable Surgical Mask

Reason

Incorrect ARTG Classification.

ARTG number: 334004

Outcome: Product defect alert

Sponsor: Aster Home Nursing Service Pty Ltd

Manufacturer: Henan Gore Medical Instruments 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: 334260

Outcome: No action

Sponsor: Arbl Resource Group

Manufacturer: Zhengzhou Shanshan Medical Supplies Co Ltd

Device/Product name: Rongbeide Robestain Disposable Medical Mask

Comment

TGA review completed, no market action required.

ARTG number: 334669

Outcome: No action

Sponsor: Smartline Machinery Pty Ltd

Manufacturer: Shenzhen Ditex Medical Factory

Device/Product name: Public N95 Respirator

Comment

TGA review completed, no market action required.