Commonwealth legislation

Therapeutic Goods Order No. 53 - Single-use Sterile Surgical Rubber Gloves (24/05/1997)

RepealedCTH

This Act has been repealed and is no longer in force. It is retained for historical reference.

Jurisdiction

Commonwealth

Collection

legislative instrument

Plain English Summary

2/10 complexity

This Order sets the mandatory safety and quality rules for single-use sterile surgical rubber gloves sold in Australia. It covers gloves made from natural or synthetic rubber that are meant for use in surgery.

What it requires:

It legally adopts the technical specifications from the Australian/New Zealand Standard 4179:1997, making specific sections (Clauses 1-9, Annex A, and Appendix XX) legally binding.
Manufacturers must ensure their gloves meet these standards for sterility, strength, and performance.

When it applies:

New gloves entering the market must comply immediately when the Order takes effect.
Existing gloves already legally sold in Australia get a 3-month grace period to meet the new standards.

Why it matters: This ensures that all surgical gloves used in Australian hospitals and clinics meet consistent safety benchmarks, protecting both patients and healthcare workers from risks like contamination or glove failure during operations.

JSON API Health / NDIS / medicines

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Current sections

Direct links to the current provisions in Therapeutic Goods Order No. 53 - Single-use Sterile Surgical Rubber Gloves (24/05/1997).

Therapeutic Goods Order No. 53 - Single-use Sterile Surgical Rubber Gloves (24/05/1997)

THERAPEUTIC GOODS ACT 1989

THERAPEUTIC GOODS ORDER No 53

Single-use Sterile Surgical Rubber Gloves

I, John Cable, delegate of the Minister for Health and Family Services for the purposes of the exercise of the Minister’s powers under Section 10 of the Therapeutic Goods Act 1989,

having consulted with the Therapeutic Goods Committee in accordance with subsection 10(4)

of the said Act, hereby:

DETERMINE that the matters specified in Clauses 1 to 9 inclusive, Annex A and

Appendix XX, in the document titled “Australian/New Zealand Standard 4179:1997 -

Single-use sterile surgical rubber gloves - Specification”, as in force on 5 May 1997 (“the Standard”), shall constitute the standard, for all single-use, sterile gloves made from natural or synthetic rubber, intended for use in surgical procedures.

This Order shall commence to operate:

a) in relation to surgical gloves already being legally supplied on the Australian market on the date of the making of this Order, this Order commences 3

months from the date of gazettal of this Order.

b) in relation to all other surgical gloves this Order commences on the date of

gazettal of this Order.

Dated on this 24th day of May 1997.

Signed John Cable

John Cable

Delegate of the Minister for Health and Family Services

Source text

Sourced from the Federal Register of Legislation (legislation.gov.au), CC BY 4.0.

1 Therapeutic Goods Order No. 53 - Single-use Sterile Surgical Rubber Gloves (24/05/1997)