Coverall,protection,CatIII,type 4b,XL

General Description:
Spray-tight biohazard-protective coverall, for use in EVD patient-isolation units for infection prevention and control against viral penetration.
Technical specifications:
Elasticated hood around face.
Elasticated cuffs and ankles.
Sleeves with elasticated thumb loop.
Protective seams providing barrier equal to fabric.
Zipper with re-sealable flap protecting leakage through seams.
Each coverall has a stitched-in neck label indicating the type and performance of the suit against the below mentioned standards.
Color: White
Material: Lightweight, do not contain rubber/ latex.
Antistatic treated on both sides. Fabric is Infective agent tested against viral penetration at minimum 1.75kPa (Class 2) (or equivalent international standard)
Non-sterile
Single Use, disposable
Size : XL

Conforms to:
European Directive 89/686/EEC on personal protective equipment Category III: Chemical protective coverall, Type 4 comply with EN14605:2005+A1:2009 (or equivalent) marketing approval certificate.
Barrier to infective agent standards: EN 14126:2003 certified passing infectious agent test according to ISO 16604:2004 (Resistance to penetration by blood‐borne pathogens using bacteriophage Phi‐X 174) standard at minimum exposure pressure of 1.75kPa (class 2) (or equivalent international standard)

Performance requirement ISO standards:
EN 340 – General requirements
EN ISO 17491-4 (EN 468) – Spray aerosol test method
EN 14325 – Test methods & performance classification
EN ISO 3758 – Textile care symbols
EN 12941 – Respiratory protective devices – powered filtering devices
EN 31092 – Determination of physiological properties – thermal and water-vapour resistance

Intended use and considerations:
Disposable spray-tight biohazard-protective coverall, for use in EVD patient-isolation units for infection prevention and control against viral penetration.
After use, the coverall must be disposed in a biohazard waste container, collected and destroyed. This is also applicable if the coverall is damaged (perforation, etc.). Please refer to WHO publication "Safe management of waste for Health Care".
Supplied with:
Supplier's instruction for use

Shelf life:
As indicated by supplier

Storage conditions:
As indicated by supplier

Packaging and labelling:
Individually packaged in a transparent plastic bag.
Labelling of the primary packaging displays, at least: product name, product reference, manufacturer name, size, type, coverall performance testing information against the mentioned standards. Information for particular storage conditions (temperature, pressure, light, humidity, etc.), as appropriate (or equivalent harmonised symbol), if applicable. All indicated at least in English.