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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 151 - 175 of 712

ARTG number: 333169

Sponsor-initiated cancellation

Manufacturer: Kuangye (Dongguan) Technology Co Ltd

Device/Product name: Mask, surgical, single use

ARTG number: 333172

Sponsor-initiated cancellation

Manufacturer: Guangdong Shenpu Technology Company Co Ltd

Device/Product name: Mask, <specify>

ARTG number: 333174

Sponsor-initiated cancellation

Manufacturer: Wuhan Orient Honest International Trade Co Ltd

Device/Product name: Public respirator, single-use

ARTG number: 333176

Sponsor-initiated cancellation

Manufacturer: ZhangJiaGang ShineYa Sanitary Products Co Ltd

Device/Product name: Mask, surgical, single use

ARTG number: 333177

Sponsor-initiated cancellation

Manufacturer: Zhuhai Qingchunyu Biotechnology Co Ltd

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

ARTG number: 333178

Sponsor-initiated cancellation

Manufacturer: Qingzhou Yaowang Pharmaceutical Co Ltd

Device/Product name: Antimicrobial surgical respirator

ARTG number: 333189

Sponsor-initiated cancellation

Manufacturer: Shandong Hualu Pharmaceutical Technology Co Ltd

Device/Product name: Mask, surgical, single use

ARTG number: 333210

Sponsor-initiated cancellation

Manufacturer: Dongguan Fores Biotechnology Co Ltd

Device/Product name: Mask, surgical, single use

ARTG number: 333251

Sponsor-initiated cancellation

Manufacturer: Sunsmed Protective Products Ltd

Device/Product name: Mask, surgical, single use

ARTG number: 333252

Sponsor-initiated cancellation

Manufacturer: Wuhan Zerui Health Gene Technology Co Ltd

Device/Product name: Mask, surgical, single use

ARTG number: 333253

Sponsor-initiated cancellation

Manufacturer: Chengdu Daxan Innovative Medical Tech Co Ltd

Device/Product name: Mask, surgical, single use

ARTG number: 333254

Sponsor-initiated cancellation

Manufacturer: Changzhou Shuangma Medical Devices Co Ltd

Device/Product name: Mask, surgical, single use

ARTG number: 333258

Sponsor-initiated cancellation

Manufacturer: Henan Huibo Medical Co Ltd

Device/Product name: Public respirator, single-use

ARTG number: 333266

Sponsor-initiated cancellation

Manufacturer: Dongguan Hongqi Electronics Co Ltd

Device/Product name: Public respirator, single-use

ARTG number: 333267

Sponsor-initiated cancellation

Manufacturer: Tianchang City Guomao Plastic Industry Co Ltd

Device/Product name: Mask, surgical, single use

ARTG number: 333270

Sponsor-initiated cancellation

Manufacturer: Zhangjiagang Zhiyi Medical Health Products Co Ltd

Device/Product name: Public respirator, single-use

ARTG number: 333281

Sponsor-initiated cancellation

Manufacturer: Nantong Gather Excellence-Cleaning Medical Materials Co Ltd

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

ARTG number: 333282

Sponsor-initiated cancellation

Manufacturer: Shaoxing Yibon Medical Co Ltd

Device/Product name: Mask, surgical, single use

ARTG number: 333283

Sponsor-initiated cancellation

Manufacturer: Bird Healthcare Pty Ltd

Device/Product name: Mask, <specify>

ARTG number: 333287

Sponsor-initiated cancellation

Manufacturer: Dongguan Hongqi Electronics Co Ltd

Device/Product name: Public respirator, single-use

ARTG number: 333289

Sponsor-initiated cancellation

Manufacturer: Shanghai Dasheng Health Products Manufacturer Co Ltd

Device/Product name: Mask, surgical, single use

ARTG number: 333291

Sponsor-initiated cancellation

Manufacturer: ESound Medical Device Co Ltd

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

ARTG number: 333292

Sponsor-initiated cancellation

Manufacturer: ESound Medical Device Co Ltd

Device/Product name: Public respirator, single-use

ARTG number: 333293

Sponsor-initiated cancellation

Manufacturer: Rizhao Sanqi Medical & Health Articles Co Ltd

Device/Product name: Mask, surgical, single use

ARTG number: 333372

Sponsor-initiated cancellation

Manufacturer: Xiantiao Dingcheng Non-Woven Products Co Ltd

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

Pages

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