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