Public respirator, single-use

Australia - English - Department of Health (Therapeutic Goods Administration)

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Available from:
Solasta Life Pty Ltd
Class:
Class 1
Authorization status:
Included
Authorization number:
339891

Public Summary

Summary for ARTG Entry:

339891

Solasta Life Pty Ltd - Public respirator, single-use

ARTG entry for

Medical Device Included Class 1

Sponsor

Solasta Life Pty Ltd

Postal Address

3 Disney Street, Stafford Heights, QLD, 4053

Australia

ARTG Start Date

21/07/2020

Product Category

Medical Device Class 1

Status

Active

Approval Area

Medical Devices

Conditions

- The inclusion of the kind of device in the ARTG is subject to compliance with all conditions placed or imposed on the ARTG entry. Refer Part 4-5, Division 2

(Conditions) of the Therapeutic Goods Act 1989 and Part 5, Division 5.2 (Conditions) of the Therapeutic Goods (Medical Devices) Regulations 2002 for

relevant information.

- Breaching conditions of the inclusion related to the device of the kind may lead to suspension or cancellation of the ARTG entry; may be a criminal offence;

and civil penalties may apply.

Manufacturers

Name

Address

Guangdong Fei Fan Mstar Technology Ltd

A1 workshop No 10 Dongnan Xincun Avenue

Zone 2 Caobian No 3 Industrial Zone

Dali Town Foshan City, Nanhai District,

China

Products

1 . Public respirator, single-use

Product Type

Single Device Product

Effective Date

21/07/2020

GMDN

57793 Public respirator, single-use

Intended Purpose

A filtering mask KN95 (filter efficiency 95%)] designed to be placed over the nose and mouth of a member of the general public to

permit normal breathing while protecting the wearer from exposure to pathogenic biological airborne particulates during a public

health medical

emergency (e.g., influenza pandemic). It is typically made of multiple layers of non-woven polymers, and incorporates a forming

nosepiece

(metal wire); it is typically secured using elastic head straps. This is a single-use device.

Specific Conditions

No Specific Conditions included on Record

© Commonwealth of Australia. This work is copyright. You are not permitted to re-transmit, distribute or commercialise the material without obtaining prior

written approval from the Commonwealth. Further details can be found at http://www.tga.gov.au/about/website-copyright.htm.

Public Summary

Page 1 of

Produced at 22.07.2020 at 08:07:17 AEST

This is not an ARTG Certificate document.

The onus is on the reader to verify the current accuracy of the information on the document subsequent to the date shown.

Visit www.tga.gov.au for contact information

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