Medical PPE

US - ANSI/AAMI PB70:2012, Level I, II, III

EU - BS EN 13795-1:2019

PRODUCT AND MANUFACTURING STANDARDS THAT ARE FOLLOWED:

As a manufacturer that takes pride in producing high quality product, our quality assurance systems and product standards meet world class standards. 

PRODUCT 

ANSI/AAMI PB70:2012 

The Association for the Advancement of Medical Instrumentation (AAMI) standard establishes a system of classification for protective apparel and drapes used in health care facilities based on their liquid barrier performance and specifies related labelling requirements and standardized test methods for determining compliance. Our products meet the relevant AAMI Level 1 to 4 standards. 

BS EN 13795:2019 

This European Standard provides information on the characteristics of single-use and reusable surgical gowns and surgical drapes that are used as medical devices for patients, clinical staff and equipment. The standard covers a range of testing requirements to validate the barrier and technical performance of the products.  Our disposable isolation gowns meet these requirements. 

MANUFACTURING 

GMP for 21 CFR Part 820 Quality System Regulation 

GMP refers to the Good Manufacturing Practice regulations enforced by the FDA. GMPs provide for systems that assure proper design, monitoring, and control of manufacturing processes and facilities. Our company has been verified to be operating with a system of assurance and control of quality and hygiene as laid down by FDA CFR Title 21 Chapter I. 

ISO 13485:2016 Medical Devices – Quality Management System 

ISO 13485:2016 specifies requirements for a quality management system where an organization must demonstrate its ability to provide medical devices and related services that meet customer and applicable regulatory requirements. Our facilities are ISO 13485 compliant. 

MARKET CLEARANCE - CE 

CE marking indicates that a product has been assessed and deemed to meet EU safety, health and environmental protection requirements.  Our products have CE certification and are therefore compliant with (EU) 2017/745 regulation on medical devices (MDR) and (EU) 2016/425 regulation on personal protective equipment (RPPE).