Our Product Certification
FDA
The requirements of medical gloves according to DIN EN 455-1,2,3 and 4
CE Marking
The CE Mark, or formerly EC mark, is a mandatory conformity marking for certain products sold within the European Economic Area (EEA) since 1985. The CE marking is also found on products sold outside the EEA that are manufactured in, or designed to be sold in, the EEA.
The CE marking is the manufacturer"s declaration that the products meet the requirements of the applicable EC directives.
The CE marking is the manufacturer"s declaration that the products meet the requirements of the applicable EC directives.
BRC
BRC-Personal Care and Household covers formulated and fabricated products which typically have higher hygiene requirements due to the nature and usage of products. Examples include cosmetics, medical devices, nappies, food wrap and household cleaners.
EN 374-1
Protective gloves against chemicals and micro-organisms.
EN 374-5
Protective gloves against chemicals and micro-organisms. Determination of resistance to penetration
EC 1935/2004
The international symbol for 'food safe' material. The symbol identifies that the material used in the product is safe for food contact.
The regulation is applicable to any product intended for food contact whether it be made of metals, ceramics, paper and board, and plastics.
Special instructions to be observed for safe and appropriate use.
The regulation is applicable to any product intended for food contact whether it be made of metals, ceramics, paper and board, and plastics.
Special instructions to be observed for safe and appropriate use.
NSF International Protocol P155
NSF International, is a not for profit, non governmental organization. They are the leading global supplier of public health and safety based risk management services.
This protocol covers disposable single-task gloves typically used for food handling, preparation, and service tasks. This protocol establishes criteria for product quality in terms of toxicology, physical properties, barrier resistance, and sanitation.
This protocol covers disposable single-task gloves typically used for food handling, preparation, and service tasks. This protocol establishes criteria for product quality in terms of toxicology, physical properties, barrier resistance, and sanitation.
ISO 13485
ISO 13485:2003 specifies requirements for a quality management system where an organization needs to demonstrate its ability to provide medical devices and related services that consistently meet customer requirements and regulatory requirements applicable to medical devices and related services.
EN 455
The requirements of medical gloves according to DIN EN 455-1,2,3 and 4.