Ame Disposable Isolation Gown AAMI PB70:2012 – Level 2

Item No.: AG2.7457

Ame Disposable Isolation gown – level 2

Item: Disposable Isolation Gown.

AAMI PB70:2012, level 2

Material: Polypropylen fabric (PP) 25gsm coated PE 15gsm

Material weight: 40g/m2

Size: regular, 120 x140 cm

Color: Blue

Steriled

Application: Low risk, to be used, for example, during blood draw, suturing, in the Intensive Care Unit (ICU), or a pathology lab. Best used for: eye procedure, tonsillectomy, laparoscopy, thoracotomy

Packaging: 1 pc/bag

USER INFORMATION:

Description

• Used in LOW risk situations
• Provides a barrier to larger amounts of fluid penetration through splatter and some fluid exposure through soaking
• Two tests are conducted to assess barrier protection performance:

+ Water impacting the surface of the gown material

+ Pressurizing the material Applicability

Blood draw from a vein, Suturing, Intensive care unit, Pathology lab

Protective barrier: Liquid-impervious coating.

• Performance Requirements at 4% AQL: Spray impact penetration <1.0g, Hydrostatic pressure >20cm
• Recommended Areas of Use*: ICU Med/Surg Unit, Dialysis, Nursery, Lab Pathology, Laboratories, Hyperbaric
• Recommended Tasks*: Blood draw, suturing, Inserting IV lines

Protection capacity: Protection from all CMR drugs or chemicals cannot be guaranteed! In case of exposition to biological hazardous materials, which do not correspond to the degree of imperviousness of the protective clothing, biocontamination of the wearer is possible.

Directions for use: Always wear with the coated side on the outside and the seam pointing downwards. Keep away from open flames and heat sources.

Proper use Daily changing interval or for 8 hours maximum (Dependent on the utilized chemicals / CMR-drugs or biologicalmaterial; in case of visible contamination immediately! Single-use items!

Care instructions: Do not wash, do not iron, do not tumble dry and do not dry clean.

Storage and transport conditions

• + Dark (protect from direct UV light and sunlight)
• + Cool (+5 to +40°C); dry; no contact with pointed and/or sharp objects

Before use: Check for any damage! Do not use damaged gowns!

Disposal: Waste requiring supervision. Waste, whose collection and disposal is subject to special requirements in view of the prevention of infection.

Shelf life: 3 years from the date of manufacture

Flammable material. Keep away from fire!

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Certificate: ISO 13485

FDA registration number: 3013502150

FDA Registration Number of The Factory Owner/Operator is 10074992