Summary for ARTG Entry:
Betel Disposable Pty Ltd - Hevea-latex examination/treatment glove, non-powdered
ARTG entry for
Medical Device Included Class 1
Betel Disposable Pty Ltd
PO Box 562,FORESTVILLE, NSW, 2087
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.
Betelcare Sdn Bhd
Lot 3342 Jalan Keretapi Lama
7 1/2 Mile off Jalan Kapar
Selangor Darul, Ehsan, 0
1. Hevea-latex examination/treatment glove, non-powdered
Single Device Product
47172 Hevea-latex examination/treatment glove, non-powdered
Disposable Latex Glove, Patient Examination
A non-sterile device made of Hevea natural rubber latex (NRL) 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 both the patient and the staff against various contamination. 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
This glove contains Shea Butter & Aloe extract to hydrate & moisturise the hands of wearers.
No Specific Conditions included on Record
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Produced at 10.11.2017 at 06:29:46 AEDT
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