AQL (Acceptable Quality Level) is a sampling standard used to measure how many defects are allowed in a production batch. In surgical gloves, it is the single most important number buyers should look at.
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?
For a batch of surgical gloves, AQL 0.65 means that in a statistically significant sample, no more than 0.65% of gloves may have pinholes. In practice, this requires:
- 100% air-leak testing of every glove before packaging
- Water-leak testing on sampled batches
- Controlled cleanroom environment (no dust, no defects on glove formers)
- Skilled operators and QC staff
No manufacturer produces zero-defect latex gloves — the material is thin and flexible. But AQL 0.65 pushes the defect rate down to a level where the barrier is reliable.
HBM Protections and AQL 0.65
All Medispo sterile surgical gloves are manufactured to AQL 0.65:
- Every glove is 100% air-leak tested and visually inspected
- Batches are sampled for water-leak testing before release
- Production is controlled under ISO 13485 quality management
- The Medispo MDR certificate explicitly covers AQL 0.65 surgical gloves
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.
