Medical Masks – AS Level 3 & ASTM Level 3

$40.00 inc. GST

The Level 1 Medical Mask with ear loops is a single-use face mask for use in healthcare where a person is at risk of blood or fluid splash. Certified to meet Australian Standard AS 4381:2015, the mask limits the passage of blood or body fluids through the mask layers.

Featuring multiple layers of lightweight material, the mask provides comfort and breathability with two ear loops to hold the mask in place.

Available on backorder

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Description

Product Information


The Level 3 Medical Mask with head ties is a single-use face mask for use in healthcare where a person is at risk of blood or fluid splash. Certified to meet Australian Standard AS 4381:2015, the mask limits the passage of blood or body fluids through the mask layers.
Featuring multiple layers of lightweight material, the mask provides comfort and breathability with two ear loops or horizontal ties to hold the mask in place.

APPLICATIONS: For general purpose medical procedures, where the wearer is not at risk of blood or bodily fluid splash or to protect staff and/or the patient from droplet exposure to microorganisms (e.g. patient with upper respiratory tract infection visits GP)

  • Ear Loops
  • TGA Certified Entry – 342895 – Nallawilli Protect Pty Limited
  • Certified to meet AS 4381: 2015 & ASTM F2100-19e1 Medical Face Masks
  • Bacterial Filtration Efficiency (BFE) 99%
  • Differential pressure, mmH2O/cm2 <5.0
  • Resistance to penetration by synthetic blood to 160mmHg
  • Included on the TGA Australian Register of Therapeutic Goods (ARTG) from September 2020
  • CE and FDA certifications
  • Non-sterile & Latex Free with Head Ties

Testing Standards


CharacteristicsTesting CriteriaTesting MethodTest Facility
Bacterial Filtration Efficiency % (BFE)160%ASTM F2101NELSON LAB
Differential Pressure, mmH2O/cm2<5.0AS 4381:2015, EN 14683:2014 Annex C
or EN 14683:2019 Annex C
VIC LAB
Resistance to penetration by synthetic
blood, minimum pressure in mmHg, pass result
160mmHgAS 4381:2015; ISO 22609 or ASTM
F1862/F1862M-13
VIC LAB

Nallawilli Protect Masks – Performance Levels


M A S K    P E R F O R M A N C E     L E V E L S
ASTM LEVEL 3Non Sterile/Sterile disposable
3 Ply, Non Woven, with ear loops and or horizontal tie
BFE > 99%, PFE > 99% and > 99%
Filtration of bacteria, dust and pollen
LEVEL 3
ASTM LEVEL 2Non Sterile/Sterile disposable
3 Ply, Non Woven with ear loops and or horizontal tie
BFE 98%, PFE 98% and >99%
Filtration of bacteria, dust and pollen
LEVEL 2
ASTM LEVEL 1Non Sterile/Sterile disposable
3 Ply, Non Woven with ear loops and or horizontal tie
BFE 95%, PFE 95% and >99%
Filtration of bacteria, dust and pollen
LEVEL 1

Nallawilli Protect Masks – Additional Information


A D D I T I O N A L    I N F O R M A T I O N
Nallawilli Protect Medical Mask – Level 3Click Here
Certificate MatrixClick Here
Nallawilli TGA CertificateClick Here
BMP 731192 Certificate and ScheduleClick Here
Test SummaryClick Here

TGA Registration


Inclusion on the TGA Australian Register of Therapeutic Goods (ARTG) – from September 2020
Nallawilli Protect’s single-use PPE masks have been designed for therapeutic use, as they are intended to reduce or prevent the transmission of disease or micro-organisms which meet the definition of a medical device. Medical device products are regulated by the TGA under the Therapeutic Goods Act 1989. Before supply in Australia, these goods need to be included on the ARTG.

To meet the requirements for inclusion on the Register, TCG must meet requirements for product quality, safety and performance in accordance with Australian or international standard requirements. This pre-market data is provided for assessment, and market authorisation is then granted to allow entry of the therapeutic goods to the ARTG.

Additional information

Weight.250 kg
Dimensions21 × 10 × 9.5 cm
Packaging

Box

Per Box

50 Masks

Per Carton

40 Boxes / 2000 Masks

Type

Medical Mask

Size

One size fits all

Construction

Disposable 3 Ply

Holder

Head Ties

TGA Registration

Yes

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