Key takeaway: EN 455-1 sets the pinhole (water-leak) AQL for examination gloves at 1.5, while the US standards ASTM D3578 (latex) and ASTM D6319 (nitrile) use AQL 2.5. A lower AQL number means a stricter bar; sampling follows ISO 2859-1, so a batch passes only if defects stay within the limit. Our nitrile examination gloves are produced to AQL 1.5 on freedom from holes, while our current released latex examination line is tested to AQL 2.5, as detailed below.

When you buy examination gloves in bulk, the quality of every box depends on statistical sampling. The Acceptable Quality Level (AQL) is the number every serious buyer should understand before placing an order. Here is what AQL means, how it works, and why it matters for medical gloves.

What Is AQL?

AQL stands for Acceptable Quality Level. It is the maximum percentage of defective units in a batch that a buyer considers acceptable during random sampling. A lower AQL number means a stricter quality bar. For example, AQL 1.5 means that in a random sample, no more than 1.5 percent of gloves may fail the specified test.

The Key AQL for Examination Gloves: 1.5 (EN 455-1) vs 2.5 (ASTM/FDA)

For medical examination gloves, the most important test is the pinhole (water-leak) test, which checks that the glove forms a complete barrier. The European standard EN 455-1 sets the pinhole AQL at 1.5. The American standard ASTM D3578 uses AQL 2.5 for freedom from holes (ASTM D6319 for nitrile is the same), matching the FDA minimum of 2.5 for patient examination gloves in 21 CFR 800.20. Any supplier claiming medical-grade gloves should be able to state their pinhole AQL.

How AQL Sampling Works

Sampling follows ISO 2859-1 (equivalent to ANSI/ASQ Z1.4). The inspector selects a sample size based on the total batch size, then counts how many sampled gloves fail the test. If the number of defects stays within the AQL limit, the batch is accepted; otherwise the whole batch is rejected. This is why AQL is a statistically defined guarantee, not a random spot check.

Why AQL Matters for Buyers

  • Safety: pinholes let fluids through, which defeats the purpose of an examination glove.
  • Compliance: hospitals, tenders and regulators routinely require a stated pinhole AQL in writing (1.5 under EN 455-1; 2.5 under ASTM D3578/D6319 and FDA 21 CFR 800.20).
  • Cost control: a loose AQL means more defective gloves in your shipment and more rejects at your end.

Our AQL Testing at Pacific Resource Global

Our AQL position differs by material, so please read both lines below.

  • Nitrile examination gloves: produced to AQL 1.5 on freedom from holes (EN 455-1). We accept this spec.
  • Current released latex examination line: AQL 2.5 on freedom from holes (SGS lot 20251010, 15 defects / 500 gloves). If a latex tender requires AQL 1.5, ask us before you order.

Pacific Resource Global manufactures 5.0 g latex examination gloves (XS–XL) in Selangor under ISO 13485:2016. Protein is kept under 200 μg/dm². Our only EU Type-Examination CE is BRI-47173-A for powdered latex (PPE 2016/425 Category III, SATRA NB 2777) — not a blanket CE mark for all gloves.

Confirm AQL Before You Order

Contact info@pacificresourceglobal.com and ask for our AQL test data and certificates before placing your next order.

Sources and standards

The requirements referenced in this article come from the following public standards and regulations:

Whichever of our product lines you pick, state the AQL you need in writing on the order.