Public respirator, single-use

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

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Public Summary

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Produced at 22.07.2020 at 08:07:17 AEST

This is not an ARTG Certificate document.

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