Surgical gloves are a higher-specification, sterile medical device distinct from examination gloves — anatomically shaped, paired by hand, and held to a stricter quality level for use in the operating theatre. This page covers the AQL, sterilisation, EN 455 standard and CE/MDR certification a surgical glove buyer must verify.
We supply sterile, anatomically shaped surgical gloves at AQL 1.0 or better, CE-marked under EU MDR with a Notified Body certificate, EN 455 conformant and ISO 13485 sourced, sterilised by EO or gamma to SAL 10⁻⁶. Available in bulk and under private label.
| Specification | Standard / option | Why it matters |
|---|---|---|
| Quality level | AQL 1.0 or better | Stricter than the AQL 1.5 examination grade |
| Sterility | Sterile, SAL 10⁻⁶ | The medical sterility assurance level |
| Shape | Anatomically shaped, hand-specific, paired | Fit and dexterity for surgery |
| Sizes | 6.0–9.0 (half sizes) | Precise surgical sizing |
| Certification | CE (MDR) + Notified Body, ISO 13485 | Higher-class device assessment |
| HS heading | 4015.12 | Rubber gloves for surgical use |
The two are not interchangeable. Surgical gloves are sterile, individually paired and anatomically shaped to left and right hands, and held to a tighter AQL 1.0 (versus 1.5 for examination gloves), with precise half-size sizing for an exact surgical fit. As a higher-risk sterile device, they require CE marking under MDR with a Notified Body number, not the self-certification path of basic examination gloves. Specifying "surgical" when you mean "examination" — or vice versa — is a costly tender error this distinction prevents.
Surgical gloves are sterilised by ethylene oxide (EO) or gamma irradiation to a sterility assurance level of SAL 10⁻⁶ — the medical standard. Each sterile lot carries a sterilisation validation record and SAL certificate, which form part of the regulatory file required to register the device in your market. We supply these as standard; a registration cannot complete without them.
Minimums start at 50,000 pairs. Sterile-barrier pouch and box artwork can be private-labelled with ISO 15223 symbols, sterilisation method and expiry. CE Declaration of Conformity and the Notified Body certificate are provided before order.
AQL 1.0 or better — a stricter standard than the AQL 1.5 of examination gloves — and they are supplied sterile to SAL 10⁻⁶.
By ethylene oxide (EO) or gamma irradiation, with a sterilisation validation record and SAL certificate per lot.
Yes — as a sterile higher-class device, the CE mark under MDR is accompanied by a Notified Body number and certificate.
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