Summary for ARTG Entry:
Ansell Ltd T/A Ansell Healthcare - Nitrile examination/treatment glove, non-powdered, sterile
ARTG entry for
Medical Device Included Class Is
Ansell Ltd T/A Ansell Healthcare
GPO Box 772 H,MELBOURNE, VIC, 3001
ARTG Start Date
Medical Device Class Is
- 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.
Ansell Healthcare Europe NV
Boulevard International 55
, Brussels, B-1070
1. Nitrile examination/treatment glove, non-powdered, sterile
Single Device Product
61631 Nitrile examination/treatment glove, non-powdered, sterile
A sterile glove 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.
No Specific Conditions included on Record
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Produced at 02.12.2017 at 04:34:16 AEDT
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