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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 26 - 50 of 62

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

ARTG number: 334583

Mask type: Surgical mask

Batch number: A24053

Sponsor: AUSTRALIAN BUSINESS MOBILES (NSW) PTY LTD

Manufacturer: Hangzhou Unibear Medical Devices Co Ltd

Label name: UNIBEAR Medical face mask

Results:

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

ARTG number: 334601

Mask type: Surgical mask

Batch number: 2020003

Sponsor: Ironbark Creek Investments

Manufacturer: Zhejiang Mediunion Healthcare Group Co Ltd

Label name: Medlogic logiguard Surgical Face Mask

Results:

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

ARTG number: 334973

Mask type: Surgical mask

Batch number: 20200412

Sponsor: Multigate Medical Products Pty Ltd

Manufacturer: Rizhao Sanqi Medical & Health Articles Co Ltd

Label name: Surgical face mask Level 2

Results:

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

ARTG number: 334973

Mask type: Surgical mask

Batch number: 20200515

Sponsor: Multigate Medical Products Pty Ltd

Manufacturer: Rizhao Sanqi Medical & Health Articles Co Ltd

Label name: Surgical face mask Level 2

Results:

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

ARTG number: 334973

Mask type: Surgical mask

Batch number: 20200506

Sponsor: Multigate Medical Products Pty Ltd

Manufacturer: Rizhao Sanqi Medical & Health Articles Co Ltd

Label name: Surgical face mask Level 2

Results:

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

ARTG number: 334973

Mask type: Surgical mask

Batch number: 20200510

Sponsor: Multigate Medical Products Pty Ltd

Manufacturer: Rizhao Sanqi Medical & Health Articles Co Ltd

Label name: Surgical face mask Level 2

Results:

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

ARTG number: 335249

Mask type: Respirator

Batch number: KN20200511D

Sponsor: Multigate Medical Products Pty Ltd

Manufacturer: Fujian Zhuyi Medical Technology Co Ltd

Label name: KN95 Respirator

Results:

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

ARTG number: 335249

Mask type: Respirator

Batch number: KN20200602D

Sponsor: Multigate Medical Products Pty Ltd

Manufacturer: Fujian Zhuyi Medical Technology Co Ltd

Label name: KN95 Respirator

Results:

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

ARTG number: 335249

Mask type: Respirator

Batch number: KN20200602C

Sponsor: Multigate Medical Products Pty Ltd

Manufacturer: Fujian Zhuyi Medical Technology Co Ltd

Label name: KN95 Respirator

Results:

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

ARTG number: 335249

Mask type: Respirator

Batch number: KN20200518B

Sponsor: Multigate Medical Products Pty Ltd

Manufacturer: Fujian Zhuyi Medical Technology Co Ltd

Label name: KN95 Respirator

Results:

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

ARTG number: 335335

Mask type: Respirator

Batch number: 4CW300325 [N/B-ACD20200420]

Sponsor: M House Pty Ltd

Manufacturer: Baoji Taidakang Medical Technology Co Ltd

Label name: Softmed N95 Respirator

Results:

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

ARTG number: 335335

Mask type: Respirator

Batch number: FMW28002

Sponsor: M House Pty Ltd

Manufacturer: Baoji Taidakang Medical Technology Co Ltd

Label name: Softmed N95 Respirator

Results:

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

ARTG number: 335335

Mask type: Respirator

Batch number: CW280520 [N/B-ACD20200420]

Sponsor: M House Pty Ltd

Manufacturer: Baoji Taidakang Medical Technology Co Ltd

Label name: Softmed N95 Respirator

Results:

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

ARTG number: 335335

Mask type: Respirator

Batch number: FMW28004

Sponsor: M House Pty Ltd

Manufacturer: Baoji Taidakang Medical Technology Co Ltd

Label name: Softmed N95 Respirator

Results:

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

ARTG number: 335335

Mask type: Respirator

Batch number: FMW28003

Sponsor: M House Pty Ltd

Manufacturer: Baoji Taidakang Medical Technology Co Ltd

Label name: Softmed N95 Respirator

Results:

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

ARTG number: 335906

Mask type: Surgical mask

Batch number: F-wk20200128

Sponsor: Sungo Australia

Manufacturer: Xiamen Probtain Medical Technology Co Ltd

Label name: Sungo Australia - Mask, surgical, single use

Results:

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

ARTG number: 335906

Mask type: Surgical mask

Batch number: FWW20050206

Sponsor: Sungo Australia

Manufacturer: Xiamen Probtain Medical Technology Co Ltd

Label name: Sungo Australia - Mask, surgical, single use

Results:

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

ARTG number: 335906

Mask type: Surgical mask

Batch number: 20200203

Sponsor: Sungo Australia

Manufacturer: Xiamen Probtain Medical Technology Co Ltd

Label name: Sungo Australia - Mask, surgical, single use

Results:

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

ARTG number: 336387

Mask type: Surgical mask

Batch number: 2020001

Sponsor: Runsmart Corporate Pty Ltd

Manufacturer: Zhejiang Mediunion Healthcare Group Co Ltd

Label name: Smartmedi Disposable Medical Mask (Type IIR)

Results:

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

ARTG number: 336833

Mask type: Surgical mask

Batch number: 1-FKNM-20040720

Sponsor: Fair Ocean Trading Australia Pty Ltd

Manufacturer: Wanxinda (Guangzhou) Technology Product Co Ltd

Label name: Disposable Face Mask 3-ply Earloop Face Mask

Results:

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

ARTG number: 336833

Mask type: Surgical mask

Batch number: 1-FKNM-20040705

Sponsor: Fair Ocean Trading Australia Pty Ltd

Manufacturer: Wanxinda (Guangzhou) Technology Product Co Ltd

Label name: Disposable Face Mask 3-ply Earloop Face Mask

Results:

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

ARTG number: 336833

Mask type: Surgical mask

Batch number: 1-FKNM-20040605

Sponsor: Fair Ocean Trading Australia Pty Ltd

Manufacturer: Wanxinda (Guangzhou) Technology Product Co Ltd

Label name: Disposable Face Mask 3-ply Earloop Face Mask

Results:

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

ARTG number: 337253

Mask type: Surgical respirator

Batch number: 6200505

Sponsor: ASPEN MEDICAL PTY LIMITED

Manufacturer: BYD Precision Manufacture Co Ltd

Label name: BYD N95 Healthcare Particulate Respirator

Results:

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

ARTG number: 337440

Mask type: Surgical respirator

Batch number: 20200514A

Sponsor: ASPEN MEDICAL PTY LIMITED

Manufacturer: Shenzhen Cathay Clean Science and Technology Co Ltd

Label name: Yijing Non-Sterile Medical mask HJ-M5F340N

Results:

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

ARTG number: 337503

Mask type: Surgical mask

Batch number: 79051993

Sponsor: Detmold Medical Pty Ltd

Manufacturer: Detmold Medical Pty Ltd

Label name: Detmold Medical Level 3 Surgical Masks

Results:

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

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