Summary for ARTG Entry:
Henry Schein Halas - Nitrile examination/treatment glove, non-powdered
ARTG entry for
Medical Device Included Class 1
Henry Schein Halas
Locked Bag 5003,ALEXANDRIA, NSW, 2015
ARTG Start Date
Medical Device Class 1
- 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.
DE Healthcare Ltd
Unit 9 Kingsthorpe Business Centre Sudland
Kingsthorpe, Northhampton, NN26NE
1. Nitrile examination/treatment glove, non-powdered
Single Device Product
56286 Nitrile examination/treatment glove, non-powdered
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.
No Specific Conditions included on Record
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