Surgical gowns are the highest-barrier gown class — reinforced, often sterile, and built for the operating theatre under EN 13795 and the top AAMI levels. This page covers the standard, barrier level, sterilisation and CE/MDR certification a surgical-gown buyer must verify.
We supply reinforced surgical gowns to EN 13795 at AAMI Level 3–4, CE-marked under EU MDR with a Notified Body certificate, ISO 13485 sourced and available sterile (EO/gamma, SAL 10⁻⁶). Available in bulk and under private label.
| Specification | Standard / option | Why it matters |
|---|---|---|
| Standard | EN 13795; AAMI PB70 Level 3–4 | Highest gown barrier classification |
| Reinforcement | Reinforced chest and sleeves | Extra protection in critical zones |
| Sterility | Sterile (EO/gamma), SAL 10⁻⁶ | Operating-theatre requirement |
| Certification | CE (MDR) + Notified Body, ISO 13485 | Higher-class device assessment |
| HS heading | 6210.10 | Garments of non-woven fabric |
A surgical gown is a critical barrier device: it protects both patient and surgeon during procedures with prolonged fluid contact. EN 13795 defines its performance, and AAMI Level 3–4 sets the barrier — Level 4 being the highest, for the most fluid-intensive surgery. Reinforced zones add protection where exposure is greatest. For any surgical tender, the EN 13795 conformance and certified AAMI level are mandatory line items, supported by a Notified Body certificate — all provided before order.
Sterile surgical gowns are EO- or gamma-sterilised to SAL 10⁻⁶, with a sterilisation validation record and SAL certificate per lot — part of the regulatory file your device registration requires. We supply these as standard.
Minimums start at 5,000 pieces. Sterile-barrier packaging can be private-labelled with ISO 15223 symbols, sterilisation method and expiry.
AAMI Level 3–4 under EN 13795, reinforced, with Level 4 the highest barrier for fluid-intensive surgery.
Yes — EO/gamma sterilised to SAL 10⁻⁶, with sterilisation validation records and SAL certificates per lot.
CE under MDR with a Notified Body certificate, ISO 13485, EN 13795 conformance and a Declaration of Conformity.
Villa No. 3, Symphony Cooperative Housing Society Ltd, Fatona, Seraulim, Colva, Goa 403708