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 126 - 150 of 712

ARTG number: 332939

Sponsor-initiated cancellation

Manufacturer: Henan Gore Medical Instruments Co Ltd

Device/Product name: Mask

ARTG number: 332942

Sponsor-initiated cancellation

Manufacturer: Hubei Kimsoul Industrial Co Ltd

Device/Product name: Airway protection face mask

ARTG number: 332943

Sponsor-initiated cancellation

Manufacturer: JinJiang Jiaxing Group Co Ltd

Device/Product name: Public respirator, single-use

ARTG number: 332975

Sponsor-initiated cancellation

Manufacturer: Tongcheng Aimei labor protection products Co Ltd

Device/Product name: Mask

ARTG number: 332983

Sponsor-initiated cancellation

Manufacturer: Foshan Nanhai Weijian Sanbang Protective Equipment Technology Co Ltd

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

ARTG number: 332984

Sponsor-initiated cancellation

Manufacturer: Shenzhen CYX Technology Co Ltd

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

ARTG number: 332985

Sponsor-initiated cancellation

Manufacturer: Shenzhen CYX Technology Co Ltd

Device/Product name: Mask, surgical, single use

ARTG number: 332986

Sponsor-initiated cancellation

Manufacturer: Qingzhou Yaowang Pharmaceutical Co Ltd

Device/Product name: Mask, surgical, single use

ARTG number: 332987

Sponsor-initiated cancellation

Manufacturer: Henan Huibo Medical Co Ltd

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

ARTG number: 332988

Sponsor-initiated cancellation

Manufacturer: Xiantao Sanda Industrial Co Ltd

Device/Product name: Mask, surgical, single use

ARTG number: 332991

Sponsor-initiated cancellation

Manufacturer: Leephick Pharmaceutic Industry Co Ltd

Device/Product name: Mask, surgical, single use

ARTG number: 333061

Sponsor-initiated cancellation

Manufacturer: Changsha Jneyl Medical Equipment Co Ltd

Device/Product name: Mask, <specify>

ARTG number: 333068

Sponsor-initiated cancellation

Manufacturer: SHANGHAI EARNTZ NONWOVEN LTD

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

ARTG number: 333079

Sponsor-initiated cancellation

Manufacturer: Dongguan Maisichuang Textile Technology Co Ltd

Device/Product name: Mask, surgical, single use

ARTG number: 333081

TGA cancellation

Manufacturer: Wuhan ZeruiHealth Gene Technology Co Ltd

Device/Product name: Mask, surgical, single use

Additional information:

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

ARTG number: 333082

Sponsor-initiated cancellation

Manufacturer: Jiande Chaomei Daily Chemicals Co Ltd

Device/Product name: Mask, surgical, single use

ARTG number: 333087

Sponsor-initiated cancellation

Manufacturer: Tangshan Yuchuang Protective Equipment Co Ltd

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

ARTG number: 333097

Sponsor-initiated cancellation

Manufacturer: Wenzhou Ouwojie Commodity Co Ltd

Device/Product name: Mask, surgical, single use

ARTG number: 333126

Sponsor-initiated cancellation

Manufacturer: Flexitex

Device/Product name: Mask, surgical, single use

ARTG number: 333128

Sponsor-initiated cancellation

Manufacturer: Ningbo Shisha Houseware Co Ltd

Device/Product name: Public respirator, single-use

ARTG number: 333130

Sponsor-initiated cancellation

Manufacturer: AC Mould Simple Medical

Device/Product name: Mask, surgical, single use

ARTG number: 333134

Sponsor-initiated cancellation

Manufacturer: Dongguan HuaGang Communication Technology Co Ltd

Device/Product name: Mask, surgical, single use

ARTG number: 333135

Sponsor-initiated cancellation

Manufacturer: Henan Huibo Medical Co Ltd

Device/Product name: Public respirator, single-use

ARTG number: 333164

Sponsor-initiated cancellation

Manufacturer: Zhuhai Qingchunyu Biotechnology Co Ltd

Device/Product name: Public respirator, single-use

ARTG number: 333166

Sponsor-initiated cancellation

Manufacturer: Hubei Mingerkang Health & Safety Applicances Co Ltd

Device/Product name: Mask, surgical, single use

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