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 176 - 200 of 712

ARTG number: 333378

Sponsor-initiated cancellation

Manufacturer: Shanghai Zogear Industries Co Ltd

Device/Product name: Mask, surgical, single use

ARTG number: 333380

Sponsor-initiated cancellation

Manufacturer: Shanghai Dasheng Health Products Manufacturer Co Ltd

Device/Product name: Public respirator, single-use

ARTG number: 333381

Sponsor-initiated cancellation

Manufacturer: Biobase Scientific (Shandong) Co Ltd

Device/Product name: Mask, surgical, single use

ARTG number: 333387

Sponsor-initiated cancellation

Manufacturer: Guangzhou Fourto Sanitary Products Co Ltd

Device/Product name: Mask, surgical, single use

ARTG number: 333388

Sponsor-initiated cancellation

Manufacturer: Wuxi Yushou Medical Appliances Co Ltd

Device/Product name: Mask, surgical, single use

ARTG number: 333391

Sponsor-initiated cancellation

Manufacturer: Guangzhou bofite safety protective equipment Co Ltd

Device/Product name: Public respirator, single-use

ARTG number: 333393

Sponsor-initiated cancellation

Manufacturer: Anhui Easyway Medical Supplies Co Ltd

Device/Product name: Public respirator, single-use

ARTG number: 333396

Sponsor-initiated cancellation

Manufacturer: ShenZhen Lijiang Health Technology Co Ltd

Device/Product name: Mask, surgical, single use

ARTG number: 333398

Sponsor-initiated cancellation

Manufacturer: Dongguan HuaGang Communication Technology Co Ltd

Device/Product name: Public respirator, single-use

ARTG number: 333403

Sponsor-initiated cancellation

Manufacturer: Henan Huibo Medical Co Ltd

Device/Product name: Public respirator, single-use

ARTG number: 333405

Sponsor-initiated cancellation

Manufacturer: Hubei Xianmeng Health Protection Commodity Co Ltd

Device/Product name: Mask, surgical, single use

ARTG number: 333406

Sponsor-initiated cancellation

Manufacturer: Henan Huibo Medical Co Ltd

Device/Product name: Mask, surgical, single use

ARTG number: 333408

Sponsor-initiated cancellation

Manufacturer: Safe Secure Packing Shenzhen Co Ltd

Device/Product name: Public respirator, single-use

ARTG number: 333410

Sponsor-initiated cancellation

Manufacturer: SHANGHAI EARNTZ NONWOVEN LTD

Device/Product name: Public respirator, single-use

ARTG number: 333411

Sponsor-initiated cancellation

Manufacturer: Henan Yu'an Medical Science and Technology Development Co Ltd

Device/Product name: Mask, surgical, single use

ARTG number: 333412

TGA cancellation

Manufacturer: HOMAR BIO TECHNOLOGY (GUANGZHOU) HOLDING CO LTD

Device/Product name: Public respirator, single-use

Additional information:

Reason for cancellation: S41GM(1) - Non response to a s41JA

ARTG number: 333413

Sponsor-initiated cancellation

Manufacturer: Hebei Shengteng Medical Devices Co Ltd

Device/Product name: Mask, surgical, single use

ARTG number: 333415

Sponsor-initiated cancellation

Manufacturer: Henan Yadu Industrial Co Ltd

Device/Product name: Mask, surgical, single use

ARTG number: 333416

Sponsor-initiated cancellation

Manufacturer: Henan Yoshield Medical Products Co Ltd

Device/Product name: Mask, surgical, single use

ARTG number: 333417

Sponsor-initiated cancellation

Manufacturer: Henan Yadu Industrial Co Ltd

Device/Product name: Public respirator, single-use

ARTG number: 333422

Sponsor-initiated cancellation

Manufacturer: Lyncmed Medical Technology (Beijing) Co Ltd

Device/Product name: Mask, surgical, single use

ARTG number: 333423

Sponsor-initiated cancellation

Manufacturer: ANSHUN HEALTH AND MEDICAL TECHNOLOGY CO LTD

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

ARTG number: 333424

Sponsor-initiated cancellation

Manufacturer: Xiantao Tsw Protective Products Co Ltd

Device/Product name: Mask, surgical, single use

ARTG number: 333425

Sponsor-initiated cancellation

Manufacturer: Tankya Developing Pty Ltd

Device/Product name: Mask, surgical, single use

ARTG number: 333426

Sponsor-initiated cancellation

Manufacturer: Hubei Safe Way Protective Product Co Ltd

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

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