You are here

Testing of face masks and respirators

TGA Laboratories testing report

21 May 2021

Background

COVID-19 has caused a rapid rise in demand for the manufacturing, importation and sale of face masks and respirators, and there has been an associated increase in medical device inclusions in the Australian Register of Therapeutic Goods (ARTG). There has also been a growth in concerns regarding the quality and performance of these kinds of devices.

The TGA Laboratories has developed capabilities to test surgical masks and respirators, to assess compliance with the requirements of key performance criteria. This testing, in conjunction with the Post-market Review of face masks, will provide the Australian community with information about the suitability of available face masks and respirators.

More information about different types of face masks and respirators has been published on the TGA website:

Testing

The TGA Laboratories is conducting an assessment of the compliance of face masks and respirators included on the ARTG[1] as well as those supplied to the National Medical Stockpile under the Therapeutic Goods (Medical Devices—Face Masks and Other Articles) (COVID-19 Emergency) Exemption 2020. The masks and respirators in the National Medical Stockpile will be prioritised within our testing plan.

The TGA Laboratories, guided by the relevant Standards, is examining the following attributes of face masks and respirators:

  1. Visual Inspection - a visual and physical examination of labelling, design and construction quality
  2. Fluid Resistance[2] - testing of the ability to provide a barrier against penetration by blood and/or other body fluids

    NOTE: For face-masks and surgical respirators with major areas where the material or thickness varies, each of these areas is tested for fluid resistance e.g. we target seams, logos and lines if present in the main body of the mask.

  3. Particle Filtration - testing of the ability to filter out small, aerosolised particles
  4. Sterility - where a face product claims to be provided in a sterile state, this will be tested.

TGA testing is targeted at assessing a few key performance parameters for masks and respirators. This does not replace the manufacturer’s obligation to have their products appropriately tested to demonstrate compliance with the essential principles for medical devices and any claimed standards on their labelling or application for ARTG inclusion.

The results of TGA laboratory testing will be made available on this page, and updated regularly. Please note that the information posted here is correct at the time of publication, and should be considered as preliminary results of what the TGA have tested against and released to date. These may be updated as more information becomes available[3].

Where only labelling deficiencies are identified, the TGA is working with sponsors to resolve the issues without unnecessarily removing products from the market, where practical.

TGA laboratory testing can only verify the performance of devices in relation to the tests we have applied. There may be products that are found to be compliant based on TGA laboratory testing, that do not comply with other regulatory requirements.

In the event a product is found non-compliant or testing results are in dispute (other than labelling deficiencies) the Sponsor is instructed to quarantine the affected products. Whilst the product is quarantined, the TGA together with the Sponsor and Manufacturer; undertake further investigation of the matter to determine what actions are appropriate.

The testing results below should be considered along with information published by the TGA about:

Footnotes

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

Testing results

Displaying 1 - 25 of 62

Enter an ARTG number, sponsor, manufacturer, label name or batch number

ARTG number: 331309

Mask type: Surgical mask

Batch number: 20200318

Sponsor: Limestone International Pty Ltd

Manufacturer: Ai Beauty Technologies Co Ltd

Label name: SproutLife, Face mask, Disposable

Results:

  • Visual inspection: Compliant
  • Fluid resistance: Compliant
  • Particle filtration: N/A
  • Sterility: N/A

ARTG number: 331309

Mask type: Surgical mask

Batch number: 20200414

Sponsor: Limestone International Pty Ltd

Manufacturer: Ai Beauty Technologies Co Ltd

Label name: SproutLife, Face mask, Disposable

Results:

  • Visual inspection: Compliant
  • Fluid resistance: Compliant
  • Particle filtration: N/A
  • Sterility: N/A

ARTG number: 331769

Mask type: Surgical mask

Batch number: 2005006

Sponsor: Point Blank Medical Pty Ltd

Manufacturer: Premier Guard Zhongshan Limited

Label name: Level 2 Face Mask Type II

Results:

  • Visual inspection: Label deficiencies
  • Fluid resistance: Non-compliant
  • Particle filtration: N/A
  • Sterility: N/A

ARTG number: 331769

Mask type: Surgical mask

Batch number: 2005007

Sponsor: Point Blank Medical Pty Ltd

Manufacturer: Premier Guard Zhongshan Limited

Label name: Level 2 Face Mask Type II

Results:

  • Visual inspection: Label deficiencies
  • Fluid resistance: Non-compliant
  • Particle filtration: N/A
  • Sterility: N/A

ARTG number: 331769

Mask type: Surgical mask

Batch number: 2004001

Sponsor: Point Blank Medical Pty Ltd

Manufacturer: Premier Guard Zhongshan Limited

Label name: Level 2 Face Mask Type II

Results:

  • Visual inspection: Label deficiencies
  • Fluid resistance: Non-compliant
  • Particle filtration: N/A
  • Sterility: N/A

ARTG number: 331773

Mask type: Surgical respirator

Batch number: 2023281

Sponsor: Olamte Pty Ltd

Manufacturer: Alpha Pro Tech Inc

Label name: N-95 Particulate Respirator, Positive Facial Lock With Magic Arch

Results:

  • Visual inspection: Label deficiencies
  • Fluid resistance: Compliant
  • Particle filtration: Compliant
  • Sterility: N/A

ARTG number: 331773

Mask type: Surgical respirator

Batch number: 2014951

Sponsor: Olamte Pty Ltd

Manufacturer: Alpha Pro Tech Inc

Label name: N-95 Particulate Respirator

Results:

  • Visual inspection: Label deficiencies
  • Fluid resistance: Compliant
  • Particle filtration: Compliant
  • Sterility: N/A

ARTG number: 332465

Mask type: Surgical mask

Batch number: 20200710

Sponsor: CK Surgitech Pty Ltd

Manufacturer: V&Q Manufacturing Corporation

Label name: V & Q Medical Face Mask

Results:

  • Visual inspection: Compliant
  • Fluid resistance: Compliant
  • Particle filtration: N/A
  • Sterility: N/A

ARTG number: 332465

Mask type: Surgical mask

Batch number: 20200525

Sponsor: CK Surgitech Pty Ltd

Manufacturer: V&Q Manufacturing Corporation

Label name: V & Q Medical Face Mask

Results:

  • Visual inspection: Compliant
  • Fluid resistance: Compliant
  • Particle filtration: N/A
  • Sterility: N/A

ARTG number: 332465

Mask type: Surgical mask

Batch number: 20200715

Sponsor: CK Surgitech Pty Ltd

Manufacturer: V&Q Manufacturing Corporation

Label name: V & Q Medical Face Mask

Results:

  • Visual inspection: Compliant
  • Fluid resistance: Compliant
  • Particle filtration: N/A
  • Sterility: N/A

ARTG number: 332479

Mask type: Surgical mask

Batch number: 30061323

Sponsor: Healtree Australian Pty Ltd

Manufacturer: Foshan Nanhai Plus Medical Co Ltd

Label name: Plus Medical Disposable Face Mask

Results:

  • Visual inspection: Label deficiencies
  • Fluid resistance: Compliant
  • Particle filtration: N/A
  • Sterility: N/A

ARTG number: 332554

Mask type: Surgical mask

Batch number: N/A

Sponsor: Zenpharm Pty Ltd

Manufacturer: FuJian YingDaWo Medical Technology Co Ltd

Label name: Endeavour Surgical Face Mask

Results:

  • Visual inspection: Label deficiencies
  • Fluid resistance: Compliant
  • Particle filtration: N/A
  • Sterility: N/A

ARTG number: 332797

Mask type: Surgical mask

Batch number: 30059114

Sponsor: Detmold Specialty Packaging Pty Ltd

Manufacturer: Foshan Nanhai Plus Medical Co Ltd

Label name: Detmold Medical Face Masks with ear loops

Results:

  • Visual inspection: Compliant
  • Fluid resistance: Compliant
  • Particle filtration: N/A
  • Sterility: N/A

ARTG number: 332846

Mask type: Surgical mask

Batch number: 20200323

Sponsor: Nissi Consult Pty Ltd

Manufacturer: Shenzhen Zhishan Medical Co Ltd

Label name: Zhi Shan Standard EarLoop Medical Mask

Results:

  • Visual inspection: Label deficiencies
  • Fluid resistance: Compliant
  • Particle filtration: N/A
  • Sterility: N/A

ARTG number: 333133

Mask type: Surgical mask

Batch number: N/B-BTW 20016

Sponsor: M House Pty Ltd

Manufacturer: Wuhan Topmed Trading Co

Label name: Softmed Surgical Face Mask Medical Disposable

Results:

  • Visual inspection: Compliant
  • Fluid resistance: Compliant
  • Particle filtration: N/A
  • Sterility: N/A

ARTG number: 333133

Mask type: Surgical mask

Batch number: N/B-BTW 20018

Sponsor: M House Pty Ltd

Manufacturer: Wuhan Topmed Trading Co

Label name: Softmed Surgical Face Mask Medical Disposable

Results:

  • Visual inspection: Compliant
  • Fluid resistance: Compliant
  • Particle filtration: N/A
  • Sterility: N/A

ARTG number: 333133

Mask type: Surgical mask

Batch number: N/B-BTW 20017

Sponsor: M House Pty Ltd

Manufacturer: Wuhan Topmed Trading Co

Label name: Softmed Surgical Face Mask Medical Disposable

Results:

  • Visual inspection: Compliant
  • Fluid resistance: Compliant
  • Particle filtration: N/A
  • Sterility: N/A

ARTG number: 333171

Mask type: Respirator

Batch number: 20200425

Sponsor: Sleepcraft Distributors Pty Ltd

Manufacturer: Wuxi JHT Group Co., Ltd

Label name: Virafree Self- Priming Filter Respirator KN95

Results:

  • Visual inspection: Label deficiencies
  • Fluid resistance: N/A
  • Particle filtration: Non-compliant
  • Sterility: N/A

ARTG number: 333428

Mask type: Respirator

Batch number: 20200402

Sponsor: Zenpharm Pty Ltd

Manufacturer: FUJIAN YONGTAI SANLIAN GARMENT CO LTD

Label name: Endeavour KN95 Mask

Results:

  • Visual inspection: Label deficiencies
  • Fluid resistance: N/A
  • Particle filtration: Non-compliant
  • Sterility: N/A

ARTG number: 333684

Mask type: Surgical mask

Batch number: YF2020/03/28 B1

Sponsor: Wiselink Group Pty Ltd

Manufacturer: C&S PAPER YUNFU CO LTD

Label name: Wiselink Group Surgical Mask Disposable 3 ply with Earloop

Results:

  • Visual inspection: Label deficiencies
  • Fluid resistance: Compliant
  • Particle filtration: N/A
  • Sterility: N/A

ARTG number: 333726

Mask type: Surgical mask

Batch number: 20031727

Sponsor: PNW International Pty Ltd

Manufacturer: Henan Yizhong Medical Instrument Co Ltd

Label name: Non-Sterile Surgical Mask

Results:

  • Visual inspection: Label deficiencies
  • Fluid resistance: Compliant
  • Particle filtration: N/A
  • Sterility: N/A

ARTG number: 333726

Mask type: Surgical mask

Batch number: 20031722

Sponsor: PNW International Pty Ltd

Manufacturer: Henan Yizhong Medical Instrument Co Ltd

Label name: Non-Sterile Surgical Mask

Results:

  • Visual inspection: Label deficiencies
  • Fluid resistance: Compliant
  • Particle filtration: N/A
  • Sterility: N/A

ARTG number: 333726

Mask type: Surgical mask

Batch number: 20032311

Sponsor: PNW International Pty Ltd

Manufacturer: Henan Yizhong Medical Instrument Co Ltd

Label name: Non-Sterile Surgical Mask

Results:

  • Visual inspection: Label deficiencies
  • Fluid resistance: Compliant
  • Particle filtration: N/A
  • Sterility: N/A

ARTG number: 334365

Mask type: Surgical mask

Batch number: 06032020

Sponsor: LTA Trading Pty Ltd

Manufacturer: NANCHANG ZHENFENG MEDICAL EQUIPMENT CO LTD

Label name: X-20 Medical Face Mask

Results:

  • Visual inspection: Compliant
  • Fluid resistance: Compliant
  • Particle filtration: N/A
  • Sterility: Compliant

ARTG number: 334583

Mask type: Surgical mask

Batch number: N/A

Sponsor: AUSTRALIAN BUSINESS MOBILES (NSW) PTY LTD

Manufacturer: Hangzhou Unibear Medical Devices Co Ltd

Label name: UNIBEAR Medical face mask

Results:

  • Visual inspection: Label deficiencies
  • Fluid resistance: Compliant
  • Particle filtration: N/A
  • Sterility: N/A

Pages