Nitrile

Main information

  • Trade name:
  • Nitrile examination/treatment glove, non-powdered
  • Class:
  • Class 1
  • Medicine domain:
  • Humans
  • Medicine type:
  • Medical device

Documents

Localization

  • Available in:
  • Nitrile examination/treatment glove, non-powdered
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 220660
  • Last update:
  • 08-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

220660

Henry Schein Halas - Nitrile examination/treatment glove, non-powdered

ARTG entry for

Medical Device Included Class 1

Sponsor

Henry Schein Halas

Postal Address

Locked Bag 5003,ALEXANDRIA, NSW, 2015

Australia

ARTG Start Date

3/03/2014

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

BA International LTD

Unit 9 Kingsthorpe Business Centre Studland

Road

Kingsthorpe, Northampton, NN2 6NE

Products

1. Nitrile examination/treatment glove, non-powdered

Product Type

Single Device Product

Effective date

3/03/2014

GMDN

56286 Nitrile examination/treatment glove, non-powdered

Intended purpose

A non-sterile device made of nitrile intended as a protective barrier when worn on the hands of healthcare

providers during patient examination/treatment or for other sanitary purposes; its inner surface is not

covered with talcum powder. The device is used mainly as a two-way barrier to protect patient/staff against

contaminants and risk of allergy to latex. It will have appropriate characteristics regarding tactility and

comfort of use, and should provide appropriate physical properties (e.g., tensile strength, resistance to

puncture, elasticity), and uniformity of dimensions (i.e., sizing consistency). 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 10.11.2017 at 03:29:28 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

There are no safety alerts related to this product.

30-10-2018

EU/3/18/2071 (Loxo Oncology Limited)

EU/3/18/2071 (Loxo Oncology Limited)

EU/3/18/2071 (Active substance: 6-(2-hydroxy-2-methylpropoxy)-4-(6-(6-((6-methoxypyridin-3-yl)methyl)-3,6-diazabicyclo[3.1.1]heptan-3-yl)pyridin-3-yl)pyrazolo[1,5-a]pyridine-3-carbonitrile) - Orphan designation - Commission Decision (2018)7272 of Tue, 30 Oct 2018 European Medicines Agency (EMA) procedure number: EMA/OD/125/18

Europe -DG Health and Food Safety