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Post-market review of face masks: Cancelled ARTG entries

8 July 2022

The Therapeutic Goods Administration (TGA) is undertaking a post-market review of face masks included in the Australian Register of Therapeutic Goods (ARTG). This page lists all face masks cancelled from the ARTG during the review. For general information about the review, including guidance for suppliers and users of face masks, see Post-market review of face masks: Overview.

Cancelled face mask ARTG entries

The ARTG entry for a face mask may be cancelled in two ways: (1) The sponsor (the supplier within Australia) may voluntarily cancel the entry or (2) the TGA may cancel the entry. With respect to the ARTG entries voluntarily cancelled by the sponsor, it is important to note that some of these devices may not be subject to a recall action. This is because the TGA may not have received any evidence for those entries about their compliance to any manufacturing standards. The TGA holds no evidence these devices meet appropriate manufacturing standards or failed to perform as intended. The decision to cancel the ARTG entry was made solely by the sponsor.

Upon applying for an ARTG inclusion, the sponsor certifies that they have evidence to support the devices safety and performance and that the device meets the Essential Principles or that the information can be obtained from the manufacturer within a specified timeframe. Therefore, it is expected that the manufacturer holds certain kinds of evidence (such as test reports to a nominated standard) to support the devices performance.

Where a face mask does not meet all the necessary regulatory requirements (e.g. non-conformance with the Essential Principles, failed laboratory testing, etc.) and/or is not performing as intended, consideration of where these masks are being used and if they pose an unacceptable risk to health and safety, including in healthcare settings is occurring. If the TGA determines that the risk is unacceptable and that manufacturer is unable to provide sufficient evidence to support the face masks performance, the TGA may decide to cancel the entry from the ARTG.

The TGA may decide not to cancel an ARTG entry due to administrative matters that can be addressed, where these masks meet all specifications and standards, and there are no deficiencies in safety, quality, performance or presentation.

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

The following entries have been cancelled from the ARTG.

Displaying 26 - 50 of 1849

Enter an ARTG number, sponsor, manufacturer or product name

ARTG number: 212766

Sponsor-initiated cancellation

Sponsor: Evershine Dental Pty Ltd

Manufacturer: Shanghai Zogear Industries Co Ltd

Device/Product name: Mask, surgical, single use

ARTG number: 213176

Sponsor-initiated cancellation

Sponsor: One Dental Pty Ltd

Manufacturer: Changzhou Primed Medical Products Co Ltd

Device/Product name: Mask, surgical, single use

ARTG number: 217968

Sponsor-initiated cancellation

Sponsor: Dental Holdings Pty Ltd

Manufacturer: Creative Contract (M) Sdn Bhd

Device/Product name: Mask, surgical, single use

ARTG number: 225647

Sponsor-initiated cancellation

Sponsor: Dentavision Pty Ltd

Manufacturer: Shanghai Dochem Industries Co Ltd

Device/Product name: Mask, surgical, single use

ARTG number: 225742

Sponsor-initiated cancellation

Sponsor: Purus Health and Medical Technologies Pty Ltd

Manufacturer: Shanghai Dochem Industries Co Ltd

Device/Product name: Mask, surgical, single use

ARTG number: 228173

Sponsor-initiated cancellation

Sponsor: McLaren Dental Pty Ltd

Manufacturer: Shanghai Dochem Industries Co Ltd

Device/Product name: Mask, surgical, single use

ARTG number: 236259

Sponsor-initiated cancellation

Sponsor: Cause Im Happy

Manufacturer: Xiantao Juenya Medical Products Co Ltd

Device/Product name: Mask, <specify>

ARTG number: 244578

Sponsor-initiated cancellation

Sponsor: Cardinal Health Australia 503 Pty Ltd

Manufacturer: Cardinal Health

Device/Product name: Mask, surgical, single use

ARTG number: 246332

Sponsor-initiated cancellation

Sponsor: O&M Halyard Australia Pty Ltd

Manufacturer: Halyard Health Inc

Device/Product name: Mask, surgical, single use

ARTG number: 259931

Sponsor-initiated cancellation

Sponsor: Plus Medical Pty Ltd

Manufacturer: Foshan Nanhai Plus Medical Co Ltd

Device/Product name: Mask, surgical, single use

ARTG number: 262425

Sponsor-initiated cancellation

Sponsor: Medical Industries Australia Hold Co Pty Ltd

Manufacturer: Shanghai Huazhe International Co Ltd

Device/Product name: Mask, surgical, single use

ARTG number: 266930

Sponsor-initiated cancellation

Sponsor: Mun Australia Pty Ltd

Manufacturer: Thai Hospotal Products Co Ltd

Device/Product name: Mask, surgical, single use

ARTG number: 272589

Sponsor-initiated cancellation

Sponsor: O&M Halyard Australia Pty Ltd

Manufacturer: Thai Hospital Products Co Ltd

Device/Product name: Mask, surgical, single use

ARTG number: 282561

Sponsor-initiated cancellation

Sponsor: Australian Safety Wholesalers Pty Ltd

Manufacturer: Australian Safety Wholesalers Pty Ltd

Device/Product name: Mask, surgical, single use

ARTG number: 283635

Sponsor-initiated cancellation

Sponsor: Bunzl Australia

Manufacturer: HUBEI XINYUAN Safety Protective Products Co Ltd

Device/Product name: Mask, surgical, single use

ARTG number: 283681

TGA cancellation

Sponsor: JC Medical Group Pty Ltd

Manufacturer: Henan JoinKona Medical Products Stock Co Ltd

Device/Product name: Mask, surgical, single use

Additional information:

  • Reason for cancellation: 41GM(1) - Non response to a s41JA

ARTG number: 284238

Sponsor-initiated cancellation

Sponsor: Wurth Australia Pty Ltd

Manufacturer: Fido Masks Co Ltd

Device/Product name: Airway protection face mask

ARTG number: 285138

Sponsor-initiated cancellation

Sponsor: Mun Australia Pty Ltd

Manufacturer: Master and Frank Enterprise Co Ltd

Device/Product name: Surgical/medical respirator, single-use

ARTG number: 286752

Sponsor-initiated cancellation

Sponsor: PERTH DENTAL SUPPLIES PTY LTD

Manufacturer: Tribest Dental Products Co Ltd

Device/Product name: Mask, surgical, single use

ARTG number: 288960

Sponsor-initiated cancellation

Sponsor: Lenan Corporation Pty Ltd

Manufacturer: Paul Murray Plc

Device/Product name: Mask, <specify>

ARTG number: 290916

Sponsor-initiated cancellation

Sponsor: Adam Dental Supplies

Manufacturer: Adam Dental Supplies

Device/Product name: Mask, surgical, single use

ARTG number: 291797

Sponsor-initiated cancellation

Sponsor: Independent Dental Supplies Pty Ltd

Manufacturer: Creative Contract (M) Sdn Bhd

Device/Product name: Mask, surgical, single use

ARTG number: 294412

Sponsor-initiated cancellation

Sponsor: Gunz Dental Pty Ltd

Manufacturer: AR Medicom Inc

Device/Product name: Mask, surgical, single use

ARTG number: 298741

Sponsor-initiated cancellation

Sponsor: Healthware Aus Pty Ltd

Manufacturer: Mydent International

Device/Product name: Mask, surgical, single use

ARTG number: 299583

Sponsor-initiated cancellation

Sponsor: Kimberly-Clark Australia Pty Ltd Professional Division

Manufacturer: Halyard Health Inc

Device/Product name: Mask, surgical, single use

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