Nitrile examination gloves are the highest-volume single line in medical consumables, and the product most healthcare distributors, hospital procurement teams and government tender buyers source first. This page gives you the specification, standards and certification a medical-grade nitrile glove must meet — AQL, EN 455, CE marking and ISO 13485 — before you shortlist a supplier.
We supply powder-free nitrile examination gloves at AQL 1.5, CE-marked under EU MDR and made to EN 455 and ASTM D6319, with batch-specific test certificates on every shipment. Available in bulk by the container and under your own private label, sourced from manufacturers built for regulated-market export.
| Specification | Standard / option | Why it matters |
|---|---|---|
| Quality level | AQL 1.5 (examination grade) | Max permitted pinhole defect rate per lot |
| Powder | Powder-free | The regulated-market default; lowers contamination risk |
| Standards | EN 455 (Parts 1–4), ASTM D6319 | The definitive medical-glove benchmarks |
| Thickness | Configurable mil (3.5–6 mil typical) | Heavier mil suits high-durability use |
| Sizes / colour | XS–XL; blue, black, violet | Black suits tattoo/industrial-adjacent demand |
| HS heading | 4015.19 | Vulcanised-rubber gloves, non-surgical |
This is the most common sourcing question in the category, and the answer shapes your whole order. Nitrile is the strongest all-round choice: it offers high puncture and chemical resistance, contains no natural rubber latex (so no Type I allergy risk), and has become the regulated-market standard for clinical use. Latex offers the best tactile sensitivity and fit at lower cost but carries latex-allergy risk. Vinyl is the lowest-cost option, suited to short-duration, low-risk tasks rather than clinical procedures. For most healthcare and clinical buyers, nitrile is the default; latex and vinyl serve specific cost and use-case niches.
AQL — Acceptable Quality Level — defines the maximum percentage of gloves per production lot that may carry a pinhole defect. AQL 1.5 means fewer than 1.5% of gloves in a lot may fail, the international threshold for medical examination gloves under EN 455. A supplier who cannot state and document an AQL is not offering a medical-grade glove, regardless of price. Every lot we supply carries a batch-specific AQL water-leak test certificate, which is the document a hospital infection-control committee or tender evaluator will ask for.
Standard packing is 100 gloves per box, 10 boxes per carton; a 20-foot container holds roughly 1,400 cartons — about 1.4 million gloves — which is the most cost-efficient order unit for this line. Minimums start at 100,000 pieces (a partial container). Own-brand box and dispenser artwork is supported, with ISO 15223 medical symbols and regulatory text handled to your market.
AQL 1.5, the medical examination standard under EN 455 and ASTM D6319, with a batch-specific test certificate on every shipment.
Yes — powder-free and CE-marked under EU MDR, sourced from ISO 13485-certified manufacturing.
Minimum 100,000 pieces; a full 20-foot container (about 1.4 million gloves) is the most cost-efficient unit.
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