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Testing of face masks and respirators

TGA Laboratories testing report

15 September 2021

On this page: Background | Testing | Test results

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

[1]

Not all products listed and/or tested on the ARTG have been supplied in Australia.

[2]

Not all face-mask standards have a requirement for fluid resistance. The TGA considers fluid resistance important for face-masks used in healthcare settings. The TGA is testing all face-masks and surgical respirators (not standard respirators) included on the ARTG for fluid resistance.

There are 3 levels of fluid resistance specified in recognised face-mask standards. The TGA is testing face-masks at the highest level of fluid resistance claimed. Face-masks with no specific fluid resistance claims are tested at the lowest level.

Face-mask with no fluid resistance may still be appropriate for use by the general public in non-healthcare settings to reduce the risk of the spread of infections, particularly in epidemic or pandemic situations.

[3]

If 'disputed' is indicated next to a non-compliant result, a disparity in testing results was found for the same batch between the TGA and the Sponsor (evidenced by a laboratory certificate); and the discrepancy could not be resolved as insufficient masks from the same batch are available for independent 3rd party testing.

A ‘Non-compliant*’ result indicates that the batch was found non-compliant by TGA testing, and this result was confirmed by 3rd party testing.

A ‘Compliant*’ result indicates that the batch was found non-compliant by TGA testing, but the results were overturned following 3rd party testing.

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

Testing results

Displaying 1 - 25 of 508

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

ARTG number: 109872

Mask type: Surgical mask

Batch number: 39184 3

Sponsor: Med-Con Pty Ltd

Manufacturer: Med-Con Pty Ltd

Label name: High Filtration Surgical Face Masks with Ties Level 3

Results:

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

ARTG number: 109872

Mask type: Surgical mask

Batch number: 40686 5

Sponsor: Med-Con Pty Ltd

Manufacturer: Med-Con Pty Ltd

Label name: Surgical Face Masks with Earloops Level 2

Results:

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

ARTG number: 109872

Mask type: Surgical mask

Batch number: 41875 5

Sponsor: Med-Con Pty Ltd

Manufacturer: Med-Con Pty Ltd

Label name: HYTEC Surgical Face Masks Ties Level 3 Barrier

Results:

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

ARTG number: 181075

Mask type: Surgical mask

Batch number: 20EAMF007

Sponsor: Medline International Two Australia Pty Ltd

Manufacturer: Medline Industries Inc

Label name: NON27377 Medline Surgical Face Mask with Ties

Results:

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

ARTG number: 181075

Mask type: Surgical mask

Batch number: 85820043664

Sponsor: Medline International Two Australia Pty Ltd

Manufacturer: Medline Industries Inc

Label name: NON27385 Medline Hyperallergenic Surgical Face Mask with Ties

Results:

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

ARTG number: 181075

Mask type: Surgical mask

Batch number: 85820032221

Sponsor: Medline International Two Australia Pty Ltd

Manufacturer: Medline Industries Inc

Label name: NON27408 Medline Surgical Fluid-Resistant Face Mask with Ties

Results:

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

ARTG number: 181075

Mask type: Surgical mask

Batch number: 85820054529

Sponsor: Medline International Two Australia Pty Ltd

Manufacturer: Medline Industries Inc

Label name: NON27410 Medline Surgical Fluid-Resistant Face Mask with Ties and Shield

Results:

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

ARTG number: 181075

Mask type: Surgical mask

Batch number: 85820032059

Sponsor: Medline International Two Australia Pty Ltd

Manufacturer: Medline Industries Inc

Label name: NON27410EL Medline Procedural Fluid-Resistant Face Mask with Earloops and Shield

Results:

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

ARTG number: 181075

Mask type: Surgical mask

Batch number: 85820065900

Sponsor: Medline International Two Australia Pty Ltd

Manufacturer: Medline Industries Inc

Label name: NON27412EL Medline Procedural Fluid-resistant Face Mask with Earloops

Results:

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

ARTG number: 181075

Mask type: Surgical mask

Batch number: 85820065896

Sponsor: Medline International Two Australia Pty Ltd

Manufacturer: Medline Industries Inc

Label name: NON27373A Medline Chamber Style Surgical Face Mask with Ties

Results:

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

ARTG number: 181075

Mask type: Surgical mask

Batch number: 85820065627

Sponsor: Medline International Two Australia Pty Ltd

Manufacturer: Medline Industries Inc

Label name: NON27412 Medline Surgical Fluid-Resistant Face Mask with Ties

Results:

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

ARTG number: 219078

Mask type: Surgical mask

Batch number: 009720

Sponsor: Ozdent Pty Ltd

Manufacturer: Ozdent Pty Ltd

Label name: MGuard 120 Face Masks Barrier Level 2

Results:

  • Fluid resistance: N/A
  • Particle filtration: N/A
  • Sterility: N/A

ARTG number: 219078

Mask type: Surgical mask

Batch number: 20200323

Sponsor: Ozdent Pty Ltd

Manufacturer: Ozdent Pty Ltd

Label name: MGuard 120 Face Masks Barrier Level 2

Results:

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

ARTG number: 219078

Mask type: Surgical mask

Batch number: 20200827

Sponsor: Ozdent Pty Ltd

Manufacturer: Ozdent Pty Ltd

Label name: MGuard 120 Face Masks Barrier Level 2

Results:

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

ARTG number: 255656

Mask type: Surgical respirator

Batch number: R210931

Sponsor: 3M Australia Pty Ltd

Manufacturer: 3M Healthcare

Label name: 3M Aura Health Care Particulate Respirator and Surgical Mask 1870+

Results:

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

ARTG number: 255656

Mask type: Surgical respirator

Batch number: R210941

Sponsor: 3M Australia Pty Ltd

Manufacturer: 3M Healthcare

Label name: 3M Aura Health Care Particulate Respirator and Surgical Mask 1870+

Results:

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

ARTG number: 255656

Mask type: Surgical respirator

Batch number: R210951

Sponsor: 3M Australia Pty Ltd

Manufacturer: 3M Healthcare

Label name: 3M Aura Health Care Particulate Respirator and Surgical Mask 1870+

Results:

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

ARTG number: 255656

Mask type: Surgical respirator

Batch number: R210921

Sponsor: 3M Australia Pty Ltd

Manufacturer: 3M Healthcare

Label name: 3M Aura Health Care Particulate Respirator and Surgical Mask 1870+

Results:

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

ARTG number: 283433

Mask type: Respirator

Batch number: N/A

Sponsor: Ultra Health Medical International Pty Ltd

Manufacturer: Handan Hengyong Protective & Clean Products Co Ltd

Label name: TITAN Respirators P2

Results:

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

ARTG number: 283433

Mask type: Respirator

Batch number: N/A

Sponsor: Ultra Health Medical International Pty Ltd

Manufacturer: Handan Hengyong Protective & Clean Products Co Ltd

Label name: TITAN Respirators P1

Results:

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

ARTG number: 290916

Mask type: Surgical mask

Batch number: 200313

Sponsor: Adam Dental Supplies

Manufacturer: Adam Dental Supplies

Label name: 50 Earloop Procedure Masks

Results:

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

ARTG number: 290916

Mask type: Surgical mask

Batch number: 190225

Sponsor: Adam Dental Supplies

Manufacturer: Adam Dental Supplies

Label name: Adam Dental Supplies BarrierUltimate Earloop Procedure Masks

Results:

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

ARTG number: 296802

Mask type: Surgical mask

Batch number: 4565

Sponsor: Steeldrill International Pty Ltd

Manufacturer: Xian Tao Fushi Protective Products Co Ltd

Label name: Ultra Health Medical Surgical Mask Level 3 Earloop

Results:

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

ARTG number: 296802

Mask type: Surgical mask

Batch number: 4717

Sponsor: Steeldrill International Pty Ltd

Manufacturer: Xian Tao Fushi Protective Products Co Ltd

Label name: Ultra Health Medical Disposable Mask Level 2 Earloop

Results:

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

ARTG number: 296802

Mask type: Surgical mask

Batch number: 4922

Sponsor: Steeldrill International Pty Ltd

Manufacturer: Xian Tao Fushi Protective Products Co Ltd

Label name: Ultra Health Medical Disposable Mask Level 2 Earloop

Results:

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

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