Public

Main information

  • Trade name:
  • Public N95 respirator
  • Class:
  • Class 1
  • Medicine domain:
  • Humans
  • Medicine type:
  • Medical device

Documents

Localization

  • Available in:
  • Public N95 respirator
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 217758
  • Last update:
  • 08-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

217758

A R Medicom Australia Pty Ltd - Public N95 respirator

ARTG entry for

Medical Device Included Class 1

Sponsor

A R Medicom Australia Pty Ltd

Postal Address

PO Box 226,THORNLEIGH, NSW, 2120

Australia

ARTG Start Date

26/11/2013

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

A R Medicom Inc Asia Ltd

21/F Federal Centre

77 Sheung On Street

, Chai Wan,

Hong Kong - SAR of China

Products

1. Public N95 respirator

Product Type

Single Device Product

Effective date

26/11/2013

GMDN

57793 Public N95 respirator

Intended purpose

A non-sterile single-use device to cover the medical professional mouth and nose to prevent cross

contamination.

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 01.12.2017 at 07:17:49 AEDT

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

21-3-2019

FDA Announces New Date for Webinar on Genome Editing in Animals

FDA Announces New Date for Webinar on Genome Editing in Animals

On April 25, 2019, FDA CVM, with participation from the CBER, will hold a public webinar about genome editing in animals, an innovative and rapidly evolving technology that offers significant public health benefits.

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15-3-2019

An international scientific conference to provide an update on genomics for food safety

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ANSES, the German Federal Institute for Risk Assessment (BfR), the National Food Institute of the Technical University of Denmark (DTU) and the Republic of Korea's National Institute of Food and Drug Safety Evaluation (NIFDS) are holding an international conference on the theme "Foodborne Pathogens & Whole Genome Sequencing: Impact on Public Health Protection", from Tuesday 26 to Thursday 28 March 2019 in Paris.

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Multi-country outbreak of Salmonella Poona infections linked to consumption of infant formula

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Published on: Tue, 12 Mar 2019 An outbreak of 32 Salmonella enterica serotype Poona cases in infants and young children has recently been identified in France (30 cases), Belgium (one case) and Luxembourg (one case). All 32 patients were infected with the same bacterial strain based on core genome multilocus sequence typing analysis. All patients had onset of symptoms between August 2018 and February 2019. Information from interviews was available for 30 patients. All consumed one of three rice-based in...

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Public consultation on electronic package leaflets and summaries of product characteristics across the EU

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26-2-2019

FDA, CDC, and CMS launch task force to help facilitate rapid availability of diagnostic tests during public health emergencies

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FDA is alerting the public that a safety clinical trial found an increased risk of blood clots in the lungs and death when a 10 mg twice daily dose of tofacitinib (Xeljanz, Xeljanz XR) was used in patients with rheumatoid arthritis (RA). FDA has not approved this 10 mg twice daily dose for RA; this dose is only approved in the dosing regimen for patients with ulcerative colitis

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21-2-2019

Annual report of the EFSA Scientific Network for Risk Assessment of GMOs for 2018

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Published on: Wed, 20 Feb 2019 The EFSA Scientific Network for Risk Assessment of GMOs (the GMO Network) was established in accordance with EFSA's strategy for cooperation and networking with Member States. The goals of the GMO Network are to improve dialogue among members, build mutual understanding of risk assessment principles, enhance knowledge and confidence in the scientific assessment carried out in the EU, and increase the transparency of the process among Member States and EFSA. The annual repo...

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20-2-2019

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Published on: Mon, 18 Feb 2019 An increase in confirmed human salmonellosis cases in the EU after 2014 triggered investigation of contributory factors and control options in poultry production. Reconsideration of the five current target serovars for breeding hens showed that there is justification for retaining Salmonella Enteritidis, Salmonella Typhimurium (including monophasic variants) and Salmonella Infantis, while Salmonella Virchow and Salmonella Hadar could be replaced by Salmonella Kentucky and ...

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Food allergies: improve information to prevent risks

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With the constant changes in eating habits and the marketing of novel foods, food allergies continue to be a public health concern.  As a result of its expert assessment work, ANSES found that there was a lack of data on the prevalence of food allergies in France. The Agency therefore delivers a series of recommendations to ensure better monitoring of food allergies, and recommends providing better information to doctors as well as to consumers subject to food allergies.

France - Agence Nationale du Médicament Vétérinaire

12-2-2019

Health Canada will be updating its safety review of breast implants

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Health Canada

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Answer to the request from the European Commission for updating the scientific advice on the impact on public health and animal health of the use of antibiotics in animals - Categorisation of antimicrobials

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28-1-2019

Public Notification: GoLean Detox contains hidden drug ingredients

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28-1-2019

Public Notification: Instinct Best Sexual Enjoyment contains hidden drug ingredient

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FDA - U.S. Food and Drug Administration

28-1-2019

Public Notification: Red Stallion Extra Strong contains hidden drug ingredient

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FDA - U.S. Food and Drug Administration

28-1-2019

Public Notification: Yong Gang contains hidden drug ingredients

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FDA - U.S. Food and Drug Administration

28-1-2019

Public Notification: Golden Ant contains hidden drug ingredient

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FDA - U.S. Food and Drug Administration

28-1-2019

Public Notification: Natural V=GRA contains hidden drug ingredients

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FDA - U.S. Food and Drug Administration

28-1-2019

Public Notification: Ultra Fit contains hidden drug ingredients

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FDA - U.S. Food and Drug Administration

28-1-2019

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FDA - U.S. Food and Drug Administration

28-1-2019

Public Notification: Slim Bio Capsules contain hidden drug ingredients

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FDA - U.S. Food and Drug Administration

28-1-2019

Public Notification: Nectar Del Amor contains hidden drug ingredient

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18-1-2019

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17-1-2019

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Europe - EFSA - European Food Safety Authority EFSA Journal

17-1-2019

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Europe - EFSA - European Food Safety Authority EFSA Journal

10-1-2019

Public Notification: Slimina contains hidden drug ingredient

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FDA - U.S. Food and Drug Administration

10-1-2019

Public Notification: The Silver Bullet contains hidden drug ingredients

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FDA - U.S. Food and Drug Administration

8-1-2019

Resapath

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France - Agence Nationale du Médicament Vétérinaire

8-1-2019

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France - Agence Nationale du Médicament Vétérinaire

22-12-2018

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Europe - EFSA - European Food Safety Authority EFSA Journal

21-12-2018

Avian influenza overview August – November 2018

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Europe - EFSA - European Food Safety Authority EFSA Journal

22-3-2019

ACSS public statement, 14-15 May 2018

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Therapeutic Goods Administration - Australia

21-3-2019

The #FDA expects significant attendance from the public and advises attendees to plan appropriately. We recommend that you arrive early to avoid long lines and inconveniences. #FDA #MedicalDevice

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FDA - U.S. Food and Drug Administration

21-3-2019

The @US_FDA is committed to protecting and promoting the public’s health. On March 25-26, the agency will host the General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee Meeting. #FDA #MedicalDevicepic.twitter.com/Wh9Sshjn6n

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FDA - U.S. Food and Drug Administration

19-3-2019


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Europe - EMA - European Medicines Agency

15-3-2019

To better achieve our mission & vision, #FDA CDRH will undergo a reorganization to better integrate CDRH's premarket & postmarket program functions along product lines. The goal of the reorganization is to improve organizational efficiencies to better mee

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FDA - U.S. Food and Drug Administration

15-3-2019

#FDA CDRH is responsible for protecting and promoting the public health.  We assure that patients and providers have timely and continued access to safe, effective, and high-quality medical devices and safe radiation-emitting products.  #MedicalDevice

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FDA - U.S. Food and Drug Administration

14-3-2019


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8-3-2019

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Therapeutic Goods Administration - Australia

7-3-2019

Public meeting communique: Regulatory options for appropriate access and safety controls for alkyl nitrites

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Therapeutic Goods Administration - Australia

1-3-2019


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1-3-2019


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1-3-2019


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26-2-2019


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7-2-2019


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Europe - EMA - European Medicines Agency

5-2-2019


Risk classification of antimicrobials used in animals opens for public consultation

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Europe - EMA - European Medicines Agency

5-2-2019


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Europe - EMA - European Medicines Agency

1-2-2019


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Europe - EMA - European Medicines Agency

31-1-2019


Human medicines European public assessment report (EPAR): Efgratin, pegfilgrastim, Neutropenia, Status: Pending

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Europe - EMA - European Medicines Agency

31-1-2019


Human medicines European public assessment report (EPAR): Cavoley, pegfilgrastim, Neutropenia, Status: Pending

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Europe - EMA - European Medicines Agency

31-1-2019

Regulatory options for appropriate access and safety controls for alkyl nitrites - Public meeting questions and answers

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Alkyl nitrites public meeting questions and answers are now available

Therapeutic Goods Administration - Australia

30-1-2019


Privacy statement on the processing of personal data in the context of public procurement procedures

Privacy statement on the processing of personal data in the context of public procurement procedures

Privacy statement on the processing of personal data in the context of public procurement procedures

Europe - EMA - European Medicines Agency

28-1-2019


Human medicines European public assessment report (EPAR): Jivi, damoctocog alfa pegol, Hemophilia A, Date of authorisation: 22/11/2018, Status: Authorised

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Europe - EMA - European Medicines Agency

25-1-2019

Public submissions on regulatory options for appropriate access and safety controls for alkyl nitrites

Public submissions on regulatory options for appropriate access and safety controls for alkyl nitrites

The TGA would like to thank respondents who provided submissions in response to the November 2018 public consultation paper

Therapeutic Goods Administration - Australia

22-1-2019


Human medicines European public assessment report (EPAR): Silodosin Recordati, silodosin, Prostatic Hyperplasia, Date of authorisation: 07/01/2019, Status: Authorised

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Europe - EMA - European Medicines Agency

22-1-2019


EMA/2018/15/CO – Ex-ante publicity of a negotiated procedure - On demand supply of books

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EMA/2018/15/CO – Ex-ante publicity of a negotiated procedure - On demand supply of books

Europe - EMA - European Medicines Agency

14-1-2019


Answer to the request from the European Commission for updating the scientific advice on the impact on public health and animal health of the use of antibiotics in animals - Preliminary risk profiling for new antimicrobials

Answer to the request from the European Commission for updating the scientific advice on the impact on public health and animal health of the use of antibiotics in animals - Preliminary risk profiling for new antimicrobials

Answer to the request from the European Commission for updating the scientific advice on the impact on public health and animal health of the use of antibiotics in animals - Preliminary risk profiling for new antimicrobials

Europe - EMA - European Medicines Agency

3-1-2019

Submissions received and high level summary: Transition to eCTD only for prescription medicines

Submissions received and high level summary: Transition to eCTD only for prescription medicines

The TGA would like to thank respondents who provided submissions in response to the October 2018 public consultation paper

Therapeutic Goods Administration - Australia

20-12-2018

Review of the Narcotic Drugs Act 1967 - Public meetings

Review of the Narcotic Drugs Act 1967 - Public meetings

The TGA will be hosting public meetings in February 2019 in Sydney, Brisbane and Melbourne

Therapeutic Goods Administration - Australia

19-12-2018

These devices offer new ways to treat or diagnose a disease, have significant advantages over existing treatment alternatives, or provide another public health benefit. Find out more about breakthrough devices:  https://go.usa.gov/xExHZ 

These devices offer new ways to treat or diagnose a disease, have significant advantages over existing treatment alternatives, or provide another public health benefit. Find out more about breakthrough devices: https://go.usa.gov/xExHZ 

These devices offer new ways to treat or diagnose a disease, have significant advantages over existing treatment alternatives, or provide another public health benefit. Find out more about breakthrough devices: https://go.usa.gov/xExHZ 

FDA - U.S. Food and Drug Administration

19-12-2018


Regulatory Science to 2025 – launch of six-month public consultation

Regulatory Science to 2025 – launch of six-month public consultation

Regulatory Science to 2025 – launch of six-month public consultation

Europe - EMA - European Medicines Agency