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Post-market review of face masks: Cancelled ARTG entries

14 January 2021

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 these devices are not subject to a recall action. This is because the TGA has not received any evidence for those entries about their compliance to any manufacturing standards. The TGA holds no evidence these devices failed to meet appropriate manufacturing standards or failed to perform as intended. The decision to cancel the ARTG entry was made solely by the sponsor.

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.

For example, 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.

The following entries have been cancelled from the ARTG.

Displaying 26 - 50 of 712

ARTG number: 236259

Sponsor-initiated cancellation

Manufacturer: Xiantao Juenya Medical Products Co Ltd

Device/Product name: Mask, <specify>

ARTG number: 259931

Sponsor-initiated cancellation

Manufacturer: Foshan Nanhai Plus Medical Co Ltd

Device/Product name: Mask, surgical, single use

ARTG number: 266930

Sponsor-initiated cancellation

Manufacturer: Thai Hospotal Products Co Ltd

Device/Product name: Mask, surgical, single use

ARTG number: 282561

Sponsor-initiated cancellation

Manufacturer: Australian Safety Wholesalers Pty Ltd

Device/Product name: Mask, surgical, single use

ARTG number: 283635

Sponsor-initiated cancellation

Manufacturer: HUBEI XINYUAN Safety Protective Products Co Ltd

Device/Product name: Mask, surgical, single use

ARTG number: 285138

Sponsor-initiated cancellation

Manufacturer: Master and Frank Enterprise Co Ltd

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

ARTG number: 286752

Sponsor-initiated cancellation

Manufacturer: Tribest Dental Products Co Ltd

Device/Product name: Mask, surgical, single use

ARTG number: 294412

Sponsor-initiated cancellation

Manufacturer: AR Medicom Inc

Device/Product name: Mask, surgical, single use

ARTG number: 298741

Sponsor-initiated cancellation

Manufacturer: Mydent International

Device/Product name: Mask, surgical, single use

ARTG number: 299583

Sponsor-initiated cancellation

Manufacturer: Halyard Health Inc

Device/Product name: Mask, surgical, single use

ARTG number: 299907

Sponsor-initiated cancellation

Manufacturer: Hubei Haixin Protective Products Co Ltd

Device/Product name: Mask, surgical, single use

ARTG number: 302725

Sponsor-initiated cancellation

Manufacturer: Anqing Kangmingna Packaging Co Ltd

Device/Product name: Mask, surgical, single use

ARTG number: 305207

Sponsor-initiated cancellation

Manufacturer: Shanghai Dochem Industries Co Ltd

Device/Product name: Mask, surgical, single use

ARTG number: 305352

Sponsor-initiated cancellation

Manufacturer: Tribest Dental Products Co Ltd

Device/Product name: Mask, surgical, single use

ARTG number: 306238

Sponsor-initiated cancellation

Manufacturer: Linear Healthcare Group

Device/Product name: Mask, surgical, single use

ARTG number: 306285

Sponsor-initiated cancellation

Manufacturer: Guangzhou Jaan Medical Co Ltd

Device/Product name: Mask, surgical, single use

ARTG number: 308620

Sponsor-initiated cancellation

Manufacturer: Xiantao Tsw Protective Products Co Ltd

Device/Product name: Mask, surgical, single use

ARTG number: 312295

Sponsor-initiated cancellation

Manufacturer: Mun Global Sdn Bhd

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

ARTG number: 326271

Sponsor-initiated cancellation

Manufacturer: Shanghai Lion Dental Co Ltd

Device/Product name: Mask, surgical, single use

ARTG number: 330610

Sponsor-initiated cancellation

Manufacturer: Young Dental Manufacturing Co 1 LLC

Device/Product name: Mask, surgical, single use

ARTG number: 331161

Sponsor-initiated cancellation

Manufacturer: Salute IND e COM de PROD MAN LTDA

Device/Product name: Mask, surgical, single use

ARTG number: 331302

Sponsor-initiated cancellation

Manufacturer: Xiantao Sanda Industrial Co Ltd

Device/Product name: Mask, surgical, single use

ARTG number: 331304

Sponsor-initiated cancellation

Manufacturer: DMC OZEL SAGLIK HIZ TH IHR SAN ve TIC LTD STI

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

ARTG number: 331425

Sponsor-initiated cancellation

Manufacturer: GREENBY BAGS

Device/Product name: Mask, surgical, single use

ARTG number: 331608

Sponsor-initiated cancellation

Manufacturer: Changzhou Shuangma Medical Devices Co Ltd

Device/Product name: Mask, <specify>

Pages

URL:https://www.tga.gov.au/post-market-review-face-masks-cancelled-artg-entries