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Post-market review of face masks: Outcomes and actions
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
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.
Further information
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.
Comment
TGA review completed, no market action required.