Isolation gowns provide barrier protection for routine and intermediate-risk care, classified by fluid-barrier performance. This page explains the AAMI barrier-level system and the specification a buyer must state to procure the right gown for the right setting.
We supply SMS non-woven isolation gowns across AAMI Levels 1–3, CE-marked and ISO 13485 sourced. Available in bulk and under private label, with the certified barrier level documented on every shipment.
| Specification | Standard / option | Why it matters |
|---|---|---|
| Barrier classification | AAMI PB70 Levels 1–3 | Defines fluid-barrier performance |
| Material | SMS non-woven (configurable GSM) | Higher GSM raises barrier and durability |
| Closure | Tie-back or thumb-loop, knit or elastic cuff | Coverage and ease of donning |
| Use | Single-use | Infection-control standard |
| HS heading | 6210.10 | Garments of non-woven fabric |
Under AAMI PB70, gown protection runs from Level 1 to Level 4. Level 1 offers minimal fluid protection for basic care; Level 2 low-risk; Level 3 moderate-risk with greater fluid exposure. (Level 4, the highest surgical barrier, falls under the surgical-gown line.) Isolation gowns cover Levels 1–3 — the routine-to-intermediate range. Stating the required level is the single most important line in an isolation-gown order; a setting that needs Level 3 cannot be served by Level 1, and over-specifying wastes budget. We document the certified level on every shipment.
The two are distinct devices. Isolation gowns (AAMI 1–3) are for general and intermediate-risk care and are typically non-sterile. Surgical gowns (AAMI 3–4, EN 13795) are reinforced, often sterile, and built for the operating theatre. Procuring for a surgical setting requires the surgical-gown line, not an isolation gown — a distinction we confirm against your use setting.
Minimums start at 10,000 pieces. Own-brand packaging and the certified AAMI level are documented per order.
Levels 1 to 3 — routine to intermediate-risk care — with the certified level documented on every shipment.
Match the level to fluid-exposure risk: Level 1 basic care, Level 3 moderate fluid exposure. Tell us the setting and we will recommend.
Surgical gowns are reinforced, often sterile, AAMI 3–4 under EN 13795 for the operating theatre; isolation gowns cover routine to intermediate care.
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