AQL (Acceptance Quality Limit) is a key parameter used in acceptance sampling. For surgical gloves, it helps buyers assess freedom from holes alongside product specifications, test methods and manufacturing quality controls.
What Is AQL?
AQL is an internationally recognized sampling standard defined in ISO 2859. A batch is sampled, and a certain number of defects are allowed within that sample.
- The lower the AQL number, the fewer defects are allowed, and the higher the quality requirement
- The higher the AQL number, the more defects are accepted, and the lower the quality
In the glove industry, common AQL levels are:
AQL | Use case |
|---|---|
4.0 | Industrial, cleaning, food handling — not medical |
1.5 | Examination gloves, general medical use |
1.0 | Higher-grade examination gloves |
0.65 | Sterile surgical gloves (current EN 455-1:2020 requirement) |
Why Did EN 455-1:2020 Change to 0.65?
The updated EN 455-1 standard, published in 2020, requires surgical gloves to meet AQL 0.65 for freedom from holes. The previous version allowed AQL 1.5.
This change reflects what surgeons have long known: every pinhole in a surgical glove is a potential transmission route for bloodborne pathogens. Lower AQL means fewer pinholes per batch, which means a more reliable barrier for both surgeon and patient.
What Does AQL 0.65 Actually Mean?
AQL 0.65 sets the acceptance quality limit used to select a sampling plan for assessing freedom from holes. A random sample of gloves is tested, and the batch passes or fails according to the sample size and acceptance criteria.
It does not mean that exactly 0.65% of gloves have pinholes, or guarantee that every batch contains no more than 0.65% defective gloves. Under comparable sampling conditions, AQL 0.65 applies stricter acceptance criteria than AQL 1.5.
For buyers, AQL should be reviewed alongside the test method, sampling plan and product specifications. Individual glove testing and manufacturing controls provide additional quality assurance, but they are separate from the AQL sampling requirement.
HBM Protections and AQL 0.65
All Medispo sterile surgical gloves are manufactured to AQL 0.65:
- Every glove undergoes electronic testing as part of our quality control process.
- Batches are sampled for water-leak testing before release
- Production is controlled under ISO 13485 quality management
Buyers evaluating suppliers should ask for:
- The declared AQL on the specification sheet
- The test method (water-leak per EN 455-1)
- Whether every glove is individually tested or only sampled
Contact our team for AQL test reports and specification sheets.
