Coverall,protection,CatIII,Type3b,M

General Description:
Coverall, protection, Category III, Type3b, size M

Intended Use:
Disposable liquid-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".

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/ yellow/orange
Material: Light weight, do not contain rubber/ latex.
Antistatic treated on both sides.
Fabric is Infective agent tested against viral penetration at minimum 1.75kPa
Non-sterile
Single Use, disposable
Size: M

Conforms to:
Regulation (EU) 2016/425 on personal protective equipment Category III: Chemical protective coverall, Type 3 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)
European Union (EU) Module C2 or D conformity to type certificate (Category III PPE).

Performance requirement ISO standards:
EN ISO 17491- 3 (EN 463) – Test methods for clothing providing protection against
Chemicals-Jet test method
EN 14325 – Test methods & performance classification of chemical protective clothing materials, seams, joins and assemblages
EN 31092 – Determination of physiological properties – thermal and water-vapour resistance

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.