Testing and Certification

Medical Device Classification

• Class I - Low risk (eg. Bandages, Gloves)
• Class IIa - Medium risk (eg. Single use instruments)
• Class IIb - Medium risk, complex design (eg. Wound contact layers)
• Class III - High risk (eg. Pacemakers)

PPE Classification - Category / Risk / Example of Protection

• Simple Design PPE (Cat. I)  / Minimal / Cleaning materials - weak action
• Intermediate Design PPE (Cat. II)  / Intermediate  / Not covered by simple or complex list
• Complex Design PPE (Cat. III)  / Serious  / Chemical attack (limited protection)

Product is manufactured and inspected to AQL 1.5 (maximum 1.5% defects in any production batch).

Our Gloves are certified to:

Protective Gloves Against Chemicals and Micro-organisms

• EN 374-1 : Terminology and Performance Requirements
• EN 374-2 : Determination of Resistance to Penetration
• EN 374-3 : Determination of Resistance to Permeation by Chemicals 

Our Gloves are certified to:

• EN 455-1 : Requirements and Testing for Freedom from Holes
• EN 455-2 : Requirements and Testing for Physical Properties
• EN 455-3 : Requirements and Testing for Biological Evaluation
• EN 455-4 : Requirements and Testing for Shelf Life Determination

• EN 14126 : 2003 Protective Clothing - Performance Requirements and Tests Methods for Protective Clothing against Infective Agents.
• EN 14125 : 2003Protective Clothing against Chemicals. Test Methods and Performance Classification of Chemical Protective Clothing Materials, Seams, Joins and Assemblages

• ASTM D6978-05 - Product has been tested for permeation by chemotherapy drugs
• ASTM F1671 - Product has been tested for viral penetration
• ASTM F1342 - Product has been puncture resistance tested
• ASTM F2100-11 - The standard for fluid-resistant protection

Classification: 

• Type I , Type II, Type IIR
• Low  ( Type I) : BFE > 95%
• Mid  (Type II) : BFE > 98%
• High  (Type IIR ) : BFE > 98% , Synthetic blood penetration > 120 mmHg