The regulations govern the quality of our products.
After extensive checks and tests, our international certifying bodies certify that our products and raw materials strictly comply with the set of standards for a given discipline or sector.
The products that we sell are subject to regulations applicable to MDs, PPE and both (MD & PPE).
UNI EN 455-1
Specifies the requirements and provides the test method for the examination gloves in order to determine their freedom from holes.
UNI EN 455-2
Specifies the requirements and provides the test methods for the physical properties of disposable medical gloves to ensure an adequate level of protection for both the patient and the wearer against mutual contamination during their use.
UNI EN 455-3
Specifies the requirements related to the evaluation of the biological safety of disposable medical gloves. It provides requirements for labeling, packaging, and disclosure of information regarding the test methods employed.
UNI EN 455-4
Specifies the requirements for the shelf-life of disposable medical gloves.
UNI EN ISO 10993-5
Biological evaluation of medical devices – Part 5: Tests for in vitro cytotoxicity. Describes the test methods for evaluating the in vitro cytotoxicity of medical devices.
UNI EN ISO 10993-10
Biological evaluation of medical devices – Part 10: Tests for skin sensitization. Describes the procedure for evaluating medical devices and their constituent materials for their potential to produce skin sensitization.
UNI EN ISO 10993-23
Biological evaluation of medical devices – Part 10: Tests for skin irritation. Describes the procedure for evaluating medical devices and their constituent materials for their potential to produce skin irritation.
ASTM F1671/F1671M-13
Standard test method for resistance of materials used in protective clothing to penetration by blood-borne pathogens using the viral penetration as a test system. Describes the properties of penetration resistance and test methods for materials used in the manufacturing of protective clothing.
ASTM D6319
Describes the test methods for performance and safety of nitrile rubber medical gloves used in medical examinations, diagnostics, and treatment procedures.
ASTM D3578
Describes the test methods for performance and safety of latex medical gloves used in medical examinations, diagnostics, and treatment procedures.
UNI CEI EN ISO 15223-1
Requirements and symbols for the labeling of medical devices.
UNI EN ISO 11137-1
Sterilization of health care products – Radiation – Part 1: Requirements for the development, validation, and routine control of sterilization processes for medical devices.
EN ISO 374-1 + A1
Specifies the terminology and performance requirements for gloves intended to protect the user against hazardous chemicals. It should be used in conjunction with UNI EN 420. The standard does not specify requirements for protection against mechanical hazards.
EN 374-2
Specifies a test method for the resistance to penetration of protective gloves against chemicals and/or hazardous microorganisms.
EN 374-4
Specifies the test method for determining the resistance of protective glove materials to degradation when in continuous contact with hazardous chemicals.
EN ISO 374-5
Specifies the requirements and test methods for gloves intended to protect the user against microorganisms.
EN 16523-1
Specifies a test method for determining the resistance of protective clothing mateials, gloves, and footwear to permeation by potentially hazardous liquid chemicals under continuous contact conditions. The method is not suitable for evaluating chemical mixtures, except for aqueous solutions.
EN 420 + A1 / EN ISO 21420
Defines the general requirements and corresponding test procedures for the design and manufacture of gloves, resistance of glove materials to water penetration, innocuousness, comfort, efficiency, marking, and information supplied by the manufacturer applicable to all protective gloves.
UNI ISO 2859-1
Sampling procedures for inspection by attributes – part 1: Sampling schemes indexed by acceptance quality limit (AQL) for lot-by-lot inspection. Describes the system of acceptance sampling inspection for attributes. It is indexed based on the acceptable quality limit (AQL).
UNI EN 14254
In Vitro Diagnostic Devices – Single-use receptacles for the collection of specimens, other than blood, from humans.
You can either send an email or call us at +39.0444.240522
Our offices will be CLOSED FOR A SHORT SUMMER BREAK from August 11th to August 20th, inclusive.
Please note that for all DELIVERIES to be made by August 8th, the final deadline for order acceptance is August 1st, 2025. All orders received after August 1st, 2025 may be delivered during the week of August 25th to August 29th, 2025.
For any specific needs, please contact our Sales Office.
Enjoy your holidays 🏖️ everyone!