Therapeutic Goods Order No. 52
Gloves for general medical and dental use
Published in the Commonwealth of Australia Gazette, 18 June 1997
COMMONWEALTH OF AUSTRALIA
Therapeutic Goods Act 1989
THERAPEUTIC GOODS ORDER NO. 52
Gloves for General Medical and Dental Use
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:
REVOKE, on and from the date this Order is gazetted, Therapeutic Goods Order No. 42,"Examination gloves for general medical and dental use" which commenced to operate on 16 January 1993; and
DETERMINE that the matters specified in Clauses 1 to 8 inclusive, Annex A and Appendix XX in the document titled "Australian/New Zealand Standard 4011:1997-Single use examination gloves - Specification", as in force at 5 May 1997 ("the Standard"), shall constitute standards for all gloves for general medical and dental use.
This Order shall commence to operate:
- in relation to gloves for general medical and dental use 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 gloves for general medical and dental use 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
Examination Gloves for General Medical and Dental Use
1. Labelling requirements
Among other things, this Order requires gloves supplied for medical purposes to be clearly marked with at least the words "examination gloves" or "medical gloves". Gloves not complying with this Order may closely resemble gloves for medical use and these may be supplied to various industries for other purposes. However, suppliers of gloves for other purposes 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 general medical and dental 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.
Note: A separate Order TGO No. 53 - Single-use sterile surgical rubber gloves applies to gloves for surgical use.