AAMI PB70 Level-3 Surgical Gown
What's the AAMI PB70:2012 Level-3 surgical gown?
The 510K Surgical Gown is a high-quality medical garment designed to meet the strictest standards. It is made from premium materials that offer excellent protection and comfort. The gown provides a reliable barrier against fluids and contaminants, ensuring the safety of both healthcare providers and patients. It is carefully crafted to fit well and allow for ease of movement during surgical procedures. The fabric is breathable, preventing excessive sweating and discomfort. With its durability and functionality, the 510K Surgical Gown is an essential item in any surgical setting, guaranteeing a sterile and protected environment for all involved.
Level-3 Requirements
AAMI Level 3 (Moderate Barrier Protection) is often specified for procedures where a moderate amount of fluid exposure is expected, such as minor trauma procedures or major surgeries.
The standard defines Level-3 performance based on two key tests:
- Water Resistance (Impact Penetration Test, AATCC 42): The fabric must resist a certain amount of water sprayed at it.
- Water Resistance (Hydrostatic Pressure Test, AATCC 127): The fabric must resist a certain amount of water pressure without penetration.
| Material | SMS fabric |
| Premarket Submission Number | K233183 |
| Weight | 45gsm |
| HydrostaticPressure(cm) AATCC-127 | >50cm |
| Water Impact | ≤1.0 g |
| Seam Strength | >30N |
| EO Residue | EO ≤ 4mg/d
ECH ≤ 9mg/d |
| Breaking Strength | >20N |
| Tearing Strength | >20N |
| Protection Level | Level 3 per AAMI PB 70 |
--Surgical Mask (ASTMF2100 Level-3)
--Surgical Cap
--shoe cover (super non-slip)
1. Caps: doctor cap, nurse cap, mob cap, clip/strip cap, astronaut caps cap
2. Face Mask: nonwoven face mask, dust mask, paper mask.
3. Ear cover: PE/CPE ear cover, nonwoven ear cover.
4. Beard cover: nonwoven beard cover with all sizes
5. Sleeve cover: nonwoven sleeve cover, PE/CPE sleeve cover, PP+CPE sleeve cover
6. Shoe cover: nonwoven shoes cover, PE/CPE shoes cover, PP+CPE shoes cover, etc.
7. Gloves: PE/CPE gloves
8. Coverall: nonwoven coverall, SMS coverall, microporous coverall, PP+PE coverall.
9. Gowns: isolation gown, surgical gown, patient gown, visitor gown
10. Aprons: PE/CPE apron, nonwoven apron
11. SMS scrub suit: shirt and trousers(long & short)
12. Bed set: disposable pillow case, nonwoven bed sheet, nonwoven bed cover.
