Glove Standards | What to Look for in Vinyl, Nitrile and Latex Exam Gloves

NICOLE ENAD 14th Oct 2024

Glove standards are essential. They ensure you can trust their quality and reliability when you wear them. The most adopted standards for exam and surgical gloves in Australia are made and maintained by:

AS NZS
ASTM
TGA

What are AS NZS, ASTM and TGA Standards?

AS/NZS Standards

Standards Australia and Standards New Zealand created the AS/NZS Standards. They are independent and non-profit organisations.

They design the standards to fit the needs of healthcare in Australia and New Zealand. Following these standards, ensure that medical gloves and gowns meet local healthcare rules. These rules follow the National Safety and Quality Health Service Standards.

ASTM Standards

ASTM International created the ASTM Standards. They used to be called the American Society for Testing and Materials. They are an independent, not-for-profit organisation.

People use ASTM standards worldwide. Many international organisations and regulators refer to them or use them. They are often the standard for global quality and safety in medical products.

TGA Standards or Listed in the ARTG

TGA refers to the Therapeutic Goods Administration. They are part of the Australian Government Department of Health. They regulate therapeutic goods like prescription medicines, vaccines, vitamins, medical devices, and more. Almost any product making health claims must be listed in the ARTG before they can be sold.

HACCP Standards

HACCP means Hazard Analysis Critical Control Points. It's a system that helps check food safety from harvesting to eating. Its goal is to lower the risk of getting sick from food.

The system looks for potential problems and aims to control them before they happen. HACCP started in Australia. But, it has become popular worldwide as the need for safe food preparation grows.

How does Australia regulate disposable examination gloves?

Australia does not have one main law for regulating personal protective equipment (PPE). Instead, there are specific laws for PPE used in certain situations.

Standards Australia has also accepted several international standards for PPE. These standards are not required unless specific laws mention them.

What is the Australian standard for disposable examination gloves?

The standard for disposable examination gloves is AS NZS 4011, ASTM D3578 and Listed in ARTG. This standard includes basic requirements that match international rules set by Standards Australia and TGA.

Australian law does not force compliance with them. However, it is still an important guide for disposable exam gloves sold in Australia.

AS NZS 4011 Single-use medical examination gloves, Part 1: Specification for gloves made from rubber latex or rubber solution
ASTM D3578 Standard Specification for Rubber Examination Gloves
Listed in ARTG. Non-sterile PPE that includes:
- aprons,
- face masks,
- gloves,
- goggles,
- gowns, and
- visors;

Intended for use in surgery, or clinical, medical, or other health services. They will need to be included in the ARTG before they can be supplied.

Vinyl gloves used in food handling must adhere to standards of HACCP related to hygiene and food safety.

Are Glove Standards required by Australian Law?

There is no law requiring specific standards for medical device safety and quality. However, the TGA (Therapeutic Goods Administration) recognises certain standards - such as listed above. This helps manufacturers show that they are following the proper procedures. And, meeting the necessary safety guidelines.

Do Livingstone gloves meet the Australian Standard?

Yes, the gloves sold from Livingstone follow the Australian standard

Their gloves adhere to AS/NZS and/or ASTM standards. This guarantees performance in durability, puncture resistance, and barrier protection. This makes them suitable for use in medical, industrial, and laboratory settings.

Here are gloves that follow AS/NZS and/or ASTM and/or HACCP:

NITRILE LATEX VINYL