Summary for ARTG Entry:
Ansell Ltd T/A Ansell Healthcare - Polychloroprene surgical glove, non-powdered
ARTG entry for
Medical Device Included Class IIa
Ansell Ltd T/A Ansell Healthcare
GPO Box 772 H,MELBOURNE, VIC, 3001
ARTG Start Date
Medical Device Class IIa
- 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 Lanka (Pvt) Ltd
Biyagama Export Processing Zone
1. Polychloroprene surgical glove, non-powdered
Single Device Product
57970 Polychloroprene surgical glove, non-powdered
A sterile surgical glove made of polychloroprene (neoprene) intended as a protective barrier when worn on
the hands of healthcare providers at the surgical site; its inner surface is not covered with talcum powder.
It is used mainly as a two-way barrier to protect patient and staff from microorganisms and risk of allergy to
No Specific Conditions included on Record
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Produced at 02.12.2017 at 04:57:14 AEDT
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