Surgical masks are a regulated medical device — not a general face mask — governed by EN 14683 and classified by bacterial filtration efficiency and fluid resistance. This page explains the Type I/II/IIR classification and the certification a surgical mask buyer must verify for clinical and tender supply.
We supply EN 14683 Type II and Type IIR surgical masks at BFE 98% or higher (Type IIR adding fluid resistance), CE-marked under EU MDR and ISO 13485 sourced, with BFE/PFE test reports. Available in bulk and under private label.
| Specification | Standard / option | Why it matters |
|---|---|---|
| Standard | EN 14683 (also ASTM F2100) | The medical surgical-mask standard |
| Type | Type I, II, IIR | Defines filtration and fluid resistance |
| Filtration | BFE ≥ 95% (I) / ≥ 98% (II, IIR) | Bacterial filtration efficiency |
| Fluid resistance | Type IIR only (splash-resistant) | Required for procedures with fluid exposure |
| Certification | CE (MDR), ISO 13485 | Medical-device conformity |
| HS heading | 6307.90 | Made-up textile mask classification |
The EN 14683 types are not interchangeable, and choosing wrong either over-spends or fails a tender. Type I (BFE ≥95%) suits low-risk and non-clinical use. Type II (BFE ≥98%) is the standard clinical mask. Type IIR adds splash/fluid resistance for procedures with a risk of fluid exposure — the "R" stands for resistant. Match the type to the use setting: a surgical theatre or fluid-risk procedure needs IIR; routine clinical use needs II. We confirm the exact type on every quotation so your tender documentation is accurate.
Because a surgical mask is a CE-marked medical device with a documented EN 14683 type and BFE test report, it qualifies for clinical and government tenders that a general 3-ply mask cannot. The BFE/PFE test report and CE Declaration of Conformity are exactly the documents a tender evaluator or infection-control committee requires — supplied as standard.
Minimums start at 50,000 pieces. Own-brand box artwork with ISO 15223 symbols and the EN 14683 type is supported.
Fluid resistance — Type IIR adds splash protection over Type II, for procedures with a risk of fluid exposure.
Yes — CE-marked under EU MDR, EN 14683 Type II/IIR, ISO 13485 sourced, with BFE test reports.
A surgical mask is a regulated medical device with a certified EN 14683 type and BFE; a 3-ply mask is a general barrier without that classification.
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