Protective gowns · standards

Surgical Gown Standard Guide

AAMI PB70 and EN 13795 define how surgical gowns resist fluid — here is what the levels mean and how to match a gown to the procedure.

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Buyer guide

What to consider

AAMI PB70 barrier levels: what each number means

AAMI PB70 grades surgical gowns into four levels of fluid resistance, and the level is the single most important number on a gown specification. Level 1 resists light fluid and is meant for minimal-risk contact. Level 2 resists splash and light spray, which covers most routine care. Level 3 resists heavier fluid exposure and is the common choice for surgery and high-fluid procedures. Level 4 resists viral penetration under pressure and is reserved for the highest-risk, high-fluid surgical work. The level is not a quality score — it is a match to the procedure, so a Level 1 gown is not 'worse' than a Level 4 gown, it is simply specified for a lower-risk task.

Level 1: minimal fluid risk, light contact
Level 2: splash and light spray, routine care
Level 3: heavier fluid exposure, surgery
Level 4: viral penetration resistance under pressure

Critical zones: where the rated barrier must hold

AAMI PB70 does not require the whole gown to meet the same barrier. It defines critical zones — the front, the sleeves and the seams — where the gown must provide its rated level, while the back and other non-critical areas may carry a lower barrier. This is why two gowns with the same level can protect differently: a gown with full critical-zone coverage protects the surgeon's front and arms, while a gown with a shorter critical zone leaves more of the torso exposed. When you compare gowns, check the critical-zone coverage on the specification sheet, not just the level number.

Critical zones are the front, sleeves and seams
The back and non-critical areas may be lower barrier
Check critical-zone coverage, not just the level

EN 13795 for the European market

EN 13795 is the European standard for surgical gowns and drapes. Instead of a single level, it classifies gowns by performance in specific areas — resistance to liquid penetration, resistance to microbial penetration and cleanliness — and grades each as standard or high performance. A gown that is high performance for liquid resistance may be standard for microbial resistance, so read the full performance profile rather than a single grade. For European export, confirm the gown is tested to EN 13795 and that the performance values match the procedure you are supplying.

EN 13795 grades liquid and microbial resistance separately
Each property is rated standard or high performance
Read the full profile, not a single grade

Match the gown to the procedure and the market

The right gown balances barrier level, material and cost against the actual procedure. For low-risk care, a Level 1 or 2 gown is sufficient and more economical. For surgery and high-fluid procedures, choose a Level 3 or 4 gown with reinforced critical zones and sealed seams. Then match the standard to your target market — AAMI PB70 for North America, EN 13795 for Europe — and request the certification file for the exact model before ordering, because a certificate that names a different model is not proof your order is compliant.

Level 1–2 for low-risk care, Level 3–4 for surgery
Reinforced critical zones and sealed seams for high fluid
Match the standard to your target market

Real products from our range

Click through for full specifications and certification files.

CE / FDA

PP Reinforced Surgical Gown Sterile Blue

Sterile PP+PE laminated surgical gown with double-reinforced front panel and forearm sleeves. Fluid-proof PE barrier, sterile-packaged for direct OR entry. EN ISO 13795 certified, CE marked. Thumbhole cuffs, wrap-around tie back. 5 sterile pouches per bag.

Certification fileView

CE / FDA

SMS Reinforced Surgical Gown Blue

SMS reinforced surgical gown with double-reinforced front panel and sleeves, EN ISO 13795 certified, CE marked. Thumbhole cuffs, wrap-around tie back, 10 pcs per bag.

Certification fileView

CE / FDA

Medical Protective Gown Premium White

Premium SMS gown with sewn seams and taped edges. EN ISO 13795 Type B rated; superior barrier for high-risk surgical and pandemic response environments.

Certification fileView

Buyer FAQ

Common buying questions

What is the difference between AAMI Level 2 and Level 3?+

Level 2 resists splash and light spray, while Level 3 resists heavier fluid exposure. Level 3 is typically used for surgery and high-fluid procedures.

What are critical zones on a surgical gown?+

Critical zones are the front, sleeves and seams where the gown must provide its rated barrier. Check the gown's critical-zone coverage to ensure it matches the procedure.

Is EN 13795 the same as AAMI PB70?+

They are different standards from different regions. EN 13795 is used in Europe and AAMI PB70 in North America. Match the standard to your target market.

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