Loren Data Corp.

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COMMERCE BUSINESS DAILY ISSUE OF JUNE 11,1996 PSA#1613

AUSTRALIA: SURGICAL GLOVES, MEDICAL AND DENTAL USE. The following notification is being circulated in accordance with Article 10.6. G/TBT/NOTIF.96.153. 1. Member to Agreement notifying: AUSTRALIA. If applicable, name of local government involved (Articles 3.2 and 7.2): 2. Agency responsible: Department of Health and Family Services. Agency or authority designated to handle comments regarding the notification can be indicated if different from above: 3. Notified under Article 2.9.2. 4. Products covered (HS or CCCN where applicable, otherwise national tariff heading. ICS numbers may be provided in addition, where applicable): Surgical gloves for general medical and dental use. 5. Title, number of pages and language(s) of the notified document: Therapeutic Goods Order 53 - Gloves for Surgical Use. 6. Description of content: Describes mandatory standard for surgical gloves based on ISO10282:1994 Single-use sterile surgical rubber gloves - Specification. 7. Objective and rationale: To ensure the safety, quality and efficacy of surgical gloves in Australia. 8. Relevant documents: ISO10282:1994 Single-use sterile surgical rubber gloves - Specification. 9. Proposed date of adoption: 30 August 1996. Proposed date of entry into force: 30 August 1996. 10. Final date for comments: 16 August 1996. 11. Texts available from: National enquiry point (X) or address and telefax number of other body: Quoting, ``Therapeutic Goods Order 53 - Gloves for Surgical Use''. (159)

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