{"id":"F2007B00442","name":"Therapeutic Goods Order No. 53 - Single-use Sterile Surgical Rubber Gloves (24/05/1997)","slug":"therapeutic-goods-order-no-53-single-use-sterile-surgical-rubber-gloves-24-05-1997","collection":"legislative_instrument","jurisdiction":"commonwealth","status":"repealed","isInForce":false,"actNumber":null,"makingDate":null,"administeringDepartment":null,"currentVersion":{"id":62300,"registerId":"commonwealth-F2007B00442-current","compilationNumber":null,"startDate":"2026-04-02","status":"Repealed","reasons":null,"registeredAt":null},"sections":[{"sectionNumber":"1","sectionType":"section","heading":"Therapeutic Goods Order No. 53 - Single-use Sterile Surgical Rubber Gloves (24/05/1997)","content":"THERAPEUTIC GOODS ACT 1989\n\nTHERAPEUTIC GOODS ORDER No 53\n\nSingle-use Sterile Surgical Rubber Gloves\n\nI, 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,\n\nhaving consulted with the Therapeutic Goods Committee in accordance with subsection 10(4)\n\nof the said Act, hereby:\n\nDETERMINE that the matters specified in Clauses 1 to 9 inclusive, Annex A and\n\nAppendix XX, in the document titled “Australian/New Zealand Standard 4179:1997 \\-\n\nSingle-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.\n\nThis Order shall commence to operate:\n\na) 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\n\nmonths from the date of gazettal of this Order.\n\nb) in relation to all other surgical gloves this Order commences on the date of\n\ngazettal of this Order.\n\nDated on this 24th day of May 1997.\n\nSigned John Cable\n\nJohn Cable\n\nDelegate of the Minister for Health and Family Services","sortOrder":0}],"analysis":{"kimi_summary":{"_metrics":{"model":"kimi-k2.5","source":"moonshot-batch","completionTokens":1204},"content_quality":"ok","complexity_score":2,"scope_assessment":{"changed":false,"description":"This Order establishes the initial mandatory standard for single-use sterile surgical rubber gloves; it represents the foundational scope rather than an expansion beyond original intent."},"complexity_factors":["Adoption by reference of external technical standard (AS/NZS 4179:1997) rather than spelling out technical requirements in the text","Bifurcated commencement dates distinguishing between existing market stock and new products","Minimal structural complexity with no nested conditions or extensive definitions"],"plain_english_summary":"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.\n\n**What it requires:**\n- 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.\n- Manufacturers must ensure their gloves meet these standards for sterility, strength, and performance.\n\n**When it applies:**\n- **New gloves** entering the market must comply immediately when the Order takes effect.\n- **Existing gloves** already legally sold in Australia get a 3-month grace period to meet the new standards.\n\n**Why it matters:**\nThis 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."}},"importantCases":[],"_links":{"self":"/api/acts/therapeutic-goods-order-no-53-single-use-sterile-surgical-rubber-gloves-24-05-1997","history":"/api/acts/therapeutic-goods-order-no-53-single-use-sterile-surgical-rubber-gloves-24-05-1997/history","analysis":"/api/acts/therapeutic-goods-order-no-53-single-use-sterile-surgical-rubber-gloves-24-05-1997/analysis","conflicts":"/api/acts/therapeutic-goods-order-no-53-single-use-sterile-surgical-rubber-gloves-24-05-1997/conflicts","importantCases":"/api/acts/therapeutic-goods-order-no-53-single-use-sterile-surgical-rubber-gloves-24-05-1997/important-cases","documents":"/api/acts/therapeutic-goods-order-no-53-single-use-sterile-surgical-rubber-gloves-24-05-1997/documents"}}