EXPLANATORY STATEMENT

Subject:  THERAPEUTIC GOODS ORDERS NUMBER 52 & 53

GLOVES FOR MEDICAL AND DENTAL USE and SURGICAL GLOVES

(Section 10, Therapeutic Goods Act 1989)

The Therapeutic Goods Act 1989 (the Act), which was enacted on January 17, 1990, regulates the establishment and maintenance of a national system of controls relating to the quality, safety and efficacy of therapeutic goods which are used in humans. The Act came into effect on February 15, 1991.

Section 10 of the Act empowers the Minister, or an Officer of the Commonwealth with the appropriate delegation, by Order published in the Commonwealth of Australia Gazette to determine, as required, standards for therapeutic goods.

Part 2 of the Act, in sections 10-15, contains provisions dealing with the standards which may be applied to therapeutic goods.  This Part covers matters such as the determination of standards

(s. 10), date of effect of standards (s. 11), special standards (s. 14) and consent being subject to conditions etc…. in certain circumstances (s. 15).

Section 10(1) of the Act states that “The Minister may, by order published in the Commonwealth of Australia Gazette, determine that matters specified in the order specify a standard for therapeutic goods or a class of therapeutic goods identified in the order (whether or not those goods are the subject of a monograph in the British Pharmacopoeia or the British Pharmacopoeia (Veterinary)”.

Surgical and examination gloves (medical gloves) are a high use item, used in a situation where exposure to infection to viruses such as HIV and Hepatitis is high.  The users expectation that the device will provide protection is also high as medical gloves are specifically sold and used for the prevention of infection. Like condoms, the quality of both surgical and examination (medical) gloves is considered a critical aspect of the National Aids program and infection control procedures in all health care facilities. There are well known cases of the transmission of infection, including HIV and Hepatitis, from doctors to patients and vice versa and there is strong expectation among health workers and patients that medical gloves are of sufficiently high quality to protect them.

The Therapeutic Goods Committee (TGC), which is the committee that advises the Minister on matters relating to standards for therapeutic goods agreed at their meeting of 19 April 1996, that

ISO 11193:1994 International Standard – Single-use rubber examination gloves – Specification and ISO 10282:1994 International Standard – Single-use sterile surgical rubber gloves – Specification should, subject to consultation, be adopted as Therapeutic Goods Orders (TGO’s). Standards Australia has since published new standards for both surgical and examination gloves which clone these International Standards. As the Australian Standards now duplicate the requirements of the International Standards TGO’s 52 & 53 have therefore been made to reference Australian/New Zealand Standard 4011:1997 – Single-use examination gloves – Specification and Australian/New Zealand Standard 4179:1997 – Single-use sterile surgical rubber gloves – Specification, respectively.

The proposal to adopt these standards as new TGO’s has been circulated widely to users and industry and all comments have been considered.

The Orders were was signed by the delegate of the Minister on 24 May 1997 for the purpose of establishing standards for medical gloves under section 10(1) of the Act.