Item No. : AGKC1.7501

Ame Disposable Isolation gown/knitted cuffs – level 1

Item: Disposable Isolation Gown

Class I exempt device

Material: Polypropylen fabric (PP)

Material weight: 40g/m2

Size: regular, 120 x140 cm

Color: Blue

Non-sterile

Application: Minimal risk – to be used: General Medical, Labs, Patient Care, and Critical Care Units

Packaging: 5 pcs/bag

USER INFORMATION:

Application area

These are non-surgical gowns includes gowns that are intended to protect the wearer from the transfer of microorganisms and bodily fluids in low- or minimal-risk patient isolation situations and that are not intended for use during surgical procedures, invasive procedures, or when there is a medium or high risk of contamination, impervious to liquids on the arms and front, which are coated; raised neckline; breathable back; pleasant and comfortable to wear.Protective barrier: Liquid-impervious coating.

Protective barrier: Liquid-impervious coating.

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