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Post-market review of face masks: Outcomes and actions
3 May 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, 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.
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 115
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.
Further information
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.
Further information
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.
Further information
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.
Further information
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.
Further information
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: 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.
Further information
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.
Further information
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.
Further information
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: 333735
Outcome: No action
Sponsor: JRL Solar Pty Ltd
Manufacturer: Shandong Daddy's Choice Health Science and Technology Co Ltd
Device/Product name: Mask, surgical, single use
Comment
TGA review completed, no market action requiredARTG number: 333736
Outcome: No action
Sponsor: JRL Solar Pty Ltd
Manufacturer: Shandong Daddy's Choice Health Science and Technology Co Ltd
Device/Product name: Mask, surgical, single use
Comment
TGA review completed, no market action requiredARTG 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 - Mask, surgical, single use
Reason
Insufficient evidence to support claims for bacterial filtration efficiency, differential pressure or splash resistance.
Further information
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: 333791
Outcome: No action
Sponsor: Melbourne Innovation Centre
Manufacturer: Zhongshan Weiyi Precision Intelligent Equipment
Device/Product name: Mask, surgical, single use
Comment
TGA review completed, no market action required.
ARTG number: 333836
Outcome: Product defect alert
Sponsor: ASC Trading Pty Ltd
Manufacturer: HuiZhou JieBai Purification Co Ltd
Device/Product name: Mask, surgical, single use
Reason
Insufficient evidence to support claims for bacterial filtration efficiency, differential pressure or splash resistance.
Further information
ARTG number: 333852
Outcome: No action
Sponsor: BWRC
Manufacturer: KINGKEY MBC LIFE TECHNOLOGY GROUP CO LTD
Device/Product name: BWRC - Mask, surgical, single use
Comment
TGA review completed, no market action required
ARTG number: 333929
Outcome: No action
Sponsor: Melbourne Innovation Centre
Manufacturer: Guandong Junyuan Aloes Medical Equipment
Device/Product name: Mask, surgical, single use
Comment
TGA review completed, no market action required.
Comment
All batches of Med-Con facemasks with a "Med-Con" logo on the mask.