Materials and Certificates

QUALITY AIMED

The medical wear is developed to minimize the risk of cross – infection and to provide protection , safety and comfort for patient and surgeon.

Raw materials proving physical barriers against fluids and microbial penetration are used.

PPE certified raw materials keep out debris, dry particulates and protect against liquid chemicals and biological hazards.

CERTIFICATES

Our Medical Devices are MDR 2017/745 compliant and tested as per standards
Surgeon gowns EN13795-1:2019
Scrub suits EN13795-2:2019
Face Masks EN14683-2019+ AC:2019
Our Personal Protective Equipment articles are PPE Regulation 2016/425 compliant and tested as per standards
Isolation gowns - Category III: EN13034:2005 + A1:2009 (PB6B); EN14605:2005 + A1:2009 (PB3B, PB4B); EN14126:2003 + AC:2004
Coveralls - Category III: Type 5, 6, 5B, 6B

OTM -Surgeon Gown