What AQL means
AQL stands for acceptable quality limit. It’s a setting in a statistical sampling plan: the worst process average a buyer will tolerate, used to decide how many gloves to inspect from a production lot and how many defects are allowed before the lot is rejected [1]. Lower numbers are stricter.
The US floor for exam gloves
FDA’s regulation on glove sampling treats AQL 2.5 as the minimum acceptable quality for patient-examination gloves and AQL 1.5 for surgeons’ gloves. FDA samples at general inspection level II and uses a water-leak test: each sampled glove is filled with 1,000 mL of water and checked immediately and again after two minutes. Lots that fail are considered adulterated [2].
The exam-glove level was 4.0 until December 19, 2008, when FDA lowered it to 2.5 [3]. That’s where the “AQL 4.0” figure still seen in some materials comes from.
What manufacturers publish
Manufacturers often state a stricter AQL for their own production — 1.5 and 1.0 both appear on current spec sheets [4]. That figure is the manufacturer’s sampling target. Read the whole line: “AQL 1.5 (Inspection Level I)” means AQL 1.5, sampled at general inspection level I [4]. Inspection levels change how many gloves are sampled from a lot, so a figure isn’t complete without its level.
What AQL doesn’t tell you
- It isn’t the defect rate of your box. A lot that passes at AQL 1.5 can still contain some defective gloves. AQL describes the sampling plan, not a guarantee for each glove [1].
- It may not be about pinholes. Manufacturers can state AQLs for different defect classes: pinholes, which affect the barrier, as well as physical dimensions or visual defects. Ask which one a figure covers.
- It isn’t a measurement of the lot you received. For that, ask for a certificate of analysis for the specific lot.
- The water-leak test has limits. The ASTM hole-detection method (D5151) finds holes that leak water under test conditions; it doesn’t define the smallest hole it can detect [5].
Editions change
The international sampling standard, ISO 2859-1, has a 2026 edition; the 1999 edition was withdrawn [1]. Supplier documents will keep citing the older edition for some time. Both define sampling plans; neither tells you the defect rate of a particular lot.
Questions to ask a supplier
- What is the pinhole AQL, and at which inspection level?
- Which defect classes do your other AQL figures cover?
- Can you send the certificate of analysis for the lot you’re offering?
How GTDI shows AQL
Every glove listing shows the manufacturer’s stated pinhole AQL with its inspection level, next to FDA’s 2.5 minimum for exam gloves, so you can see how the two compare. Where a manufacturer’s documents differ, the listing shows the figure from its current data sheet.
This guide is general information, not regulatory or clinical advice.
Sources
- ISO 2859-1:1999 (withdrawn) and ISO 2859-1:2026, Sampling procedures for inspection by attributes (2026 edition published Jan 22, 2026; catalogue pages accessed Oct 4, 2026).
- 21 CFR 800.20, Gloves; sample plans and test method for leakage (eCFR, current as of Oct 1, 2026).
- Federal Register 71 FR 75865 (Dec 19, 2006; effective Dec 19, 2008).
- Ansell, MICRO-TOUCH Nitrile product data sheet (AQL 1.5, inspection level I; undated, accessed Oct 4, 2026); HARPS Global, sempermed safe datasheet (AQL 1.0, 08/2026).
- ASTM D5151-19(2023), Detection of Holes in Medical Gloves (store page updated Sep 27, 2023; scope summary).