Therapeutic Goods Order No. 53
Single-use sterile surgical rubber gloves
Federal Register of Legislative Instruments (FRLI): Legislative Instrument - F2007B00442
Published in the Commonwealth of Australia Gazette, 18 June 1997
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COMMONWEALTH OF AUSTRALIA
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:
- 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.
- in relation to all other surgical gloves this Order commences on the date of gazettal of this Order.
Dated May 1997
John Cable
Delegate of the Minister for Health and Family Services
SUPPLEMENTARY NOTES
Single-use Sterile Surgical Rubber Gloves
1. Labelling requirements
Among other things, this Order requires gloves supplied for surgical use to be clearly marked"surgical gloves". Gloves not complying with this Order may closely resemble surgical gloves and these may be supplied to various industries for other purposes. However, suppliers of such gloves are reminded that the definition of therapeutic goods in the Therapeutic Goods Act 1989 includes:
"goods that are represented in any way to be, or that are, whether because of the way in which they are presented or for any other reason, ..."
All gloves resembling medical gloves, supplied into areas such as hospitals, health care facilities and doctors surgeries are deemed to fall under the definition of therapeutic goods as it is considered likely that they will be taken to be for therapeutic use. Suppliers of gloves for non-medical purposes into these areas must advise the buyer that the product is not for medical use and should ensure that their products are easily distinguishable from medical gloves by clearly labelling them "not for medical use" or with words having a similar meaning.
Suppliers of non-medical gloves into these areas who do not clearly identify their products as 'not for medical use' may be liable for prosecution under the Therapeutic Goods Act 1989 or other Commonwealth laws.
2. Presumption of single use
It is presumed that gloves for surgical use supplied in Australia are for single use only. Sponsors who wish to supply gloves intended for multiple use will be required to demonstrate safety of multiple use. Multiple use gloves will still be subject to all of the requirements of this Therapeutic Goods Order.