Standards

ASTM D6319 – the US standard for nitrile examination gloves

The US specification for nitrile examination gloves, and the one difference that matters in a tender: ASTM accepts AQL 2.5 where EN 455‑1 requires 1.5.

Niels Kristian BitschJuly 21, 20235 min read

ASTM D6319 – the US standard for nitrile examination gloves – Eastwest Medico

If you buy nitrile examination gloves for a market that includes the United States, ASTM D6319 is the specification your supplier must meet. It is the US counterpart to EN 455, it is what the FDA recognises for nitrile exam gloves, and it differs from the European standard in one respect that matters commercially: the acceptable defect rate.

The current edition is ASTM D6319-19(2023) – the 2019 revision, reapproved in 2023. A specification citing "ASTM D6319-19" without the reapproval year is referencing an older publication of the same text.

What the standard covers

ASTM D6319 is a specification, not a test method. It sets the requirements a nitrile rubber examination glove must satisfy and names the test methods used to verify each one. It covers ambidextrous gloves, paired gloves and gloves supplied by size, in sterile and non-sterile forms.

It is the nitrile equivalent of ASTM D3578, which covers natural rubber latex examination gloves. Neither applies to surgeons' gloves – those fall under separate specifications with tighter requirements.

The requirements fall into five groups, each with its own inspection level and AQL:

Requirement

Related defect

Inspection level

AQL

Sterility

Fails sterility

Per U.S. Pharmacopeia

N/A

Freedom from holes

Holes

G-1

2.5

Dimensions

Width, length, thickness

S-2

4.0

Physical properties

Before and after accelerated ageing

S-2

4.0

Powder-free residue

Exceeds maximum limit

N = 5

N/A

Powder amount

Exceeds recommended maximum

N = 2

N/A

That table is worth reading carefully, because "AQL 2.5" refers only to freedom from holes. Dimensions and physical properties are inspected separately at AQL 4.0. A supplier quoting a single AQL figure for the product is quoting the barrier test, not the whole specification.

Sampling follows ISO 2859, and the standard explicitly permits the purchaser and seller to agree levels more comprehensive than the table – the same escape hatch EN ISO 374-2 provides, and worth using.

Ageing is performed to ASTM D573 by one of two methods:

70 ± 2 °C for 166 ± 2 hours – this is the referee condition

100 ± 2 °C for 22 ± 0.3 hours – permitted, but not the referee method

If a report does not say which was used, ask. Tensile specimens are cut with an ASTM D412 Die C, freedom from holes is tested to D5151, and powder residue to D6124. Both glove surfaces must be free of talc.

The AQL difference, and why it matters in a tender

This is the single most useful thing to know about the two standards side by side.

AQL for freedom from holes

ASTM D6319 (examination gloves, US)

2.5, inspection level G-1

EN 455-1 (examination gloves, EU)

1.5, inspection level I, code letter L

Both describe the same thing: the sampling plan's acceptance threshold, not the proportion of delivered gloves that leak. But the European limit is tighter, and the sampling plans differ as well, so the two are not comparable by AQL number alone. A glove batch that passes ASTM D6319 has not necessarily passed EN 455-1, and a supplier who offers "ASTM D6319 compliant" against a European tender has answered a different question from the one asked.

For more on how the figure is derived and what it does and does not guarantee, see What is AQL in nitrile gloves?

This is why our own nitrile examination gloves are managed to AQL 1.5 and documented against both standards. Supplying one market to the other's standard is the kind of gap that surfaces only when a batch is rejected.

Medical grade versus industrial grade

The phrase "industrial grade" has no regulatory definition, which is exactly why it is used loosely. In practice it means a glove that did not meet, or was never tested against, the medical specification.

A medical examination glove has:

Been tested to ASTM D6319 or EN 455 and holds documentation to prove it

Passed the water leak test at the required AQL

FDA clearance for medical use in the US market, or a CE mark under MDR 2017/745 in the EU

A traceable lot number and a manufacturer quality system behind it

An industrial glove may be perfectly serviceable for cleaning, food handling, hairdressing or automotive work. It is not a barrier device for patient contact, and it must not be substituted into clinical stock because the price is better. Where a glove will touch patients or bodily fluids, the documentation is the product.

Powder is not an option in the US

The FDA banned powdered patient examination gloves, powdered surgeons' gloves and absorbable powder for lubricating surgeons' gloves, with the rule effective from January 2017. Powdered gloves cannot be sold for medical use in the US market.

ASTM D6319 accordingly sets a maximum powder residue limit and requires both glove surfaces to be talc-free. Any nitrile examination glove offered for the US medical market today is powder-free, and a supplier quoting powdered stock for that market is quoting something unsaleable.

What to require in a tender

The edition: ASTM D6319-19(2023), stated in full.

A test report from an accredited laboratory, identifying the product and lot, not a self-declaration.

The AQL achieved for freedom from holes, and confirmation of which standard's limit it was measured against.

Tensile strength and elongation results both before and after ageing – the after-ageing figures are the ones that predict performance at the end of shelf life – and which ageing method was used, since the standard permits two.

The AQL and inspection level for each characteristic, not one figure for the product: freedom from holes at 2.5/G-1 is a different test from dimensions and physical properties at 4.0/S-2.

Powder residue results and confirmation of talc-free surfaces.

Where the US market is in scope, evidence of FDA clearance for medical use.

Where the EU market is also in scope, EN 455 documentation as well. The two are not interchangeable.

Key takeaways

The current edition is ASTM D6319-19(2023). Cite the reapproval year.

It is a specification for nitrile examination gloves, the counterpart to ASTM D3578 for latex. Neither covers surgeons' gloves.

ASTM D6319 accepts AQL 2.5 at inspection level G-1 for freedom from holes; EN 455-1 requires 1.5 at level I, code letter L. Neither the limit nor the plan is the same.

"AQL 2.5" covers freedom from holes only. Dimensions and physical properties are inspected separately at AQL 4.0, level S-2.

Ageing offers two methods – 70 °C for 166 h (the referee condition) or 100 °C for 22 h. Ask which was used.

Powdered examination gloves have been prohibited for US medical use since January 2017.

"Industrial grade" is not a standard. It means the medical specification was not met or not tested.

Frequently asked questions

Is ASTM D6319 accepted in the European Union? Not as a substitute for EN 455. EU market access for a medical glove requires CE marking under MDR 2017/745, supported by EN 455 documentation. ASTM D6319 results are useful supporting evidence, particularly for tensile properties, but they do not satisfy the European requirement.

Does ASTM D6319 cover chemical protection? No. It addresses barrier integrity, dimensions and physical properties for medical use. Chemical resistance is covered by EN ISO 374, and cytostatic drug permeation by ASTM D6978.

What is the difference between ASTM D6319 and ASTM D3578? The material. D6319 specifies nitrile rubber examination gloves, D3578 natural rubber latex ones. The structure of the two specifications is closely similar.

Niels Kristian Bitsch, managing director of Eastwest Medico ApS

Niels Kristian BitschManaging director, Eastwest Medico ApS

Seventeen years sourcing and supplying medical gloves and PPE to governments, UN agencies, NGOs and healthcare systems. Writes on glove standards, quality management and responsible sourcing for institutional buyers, working from the source standards rather than secondary summaries.

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