EU Compliance: PPE Regulations and Safety Standards
At GIO SIOLUTIONS, we prioritize quality and compliance with EU regulations for all our single-use gloves and PPE products. This page outlines the key regulations and standards that govern our products, ensuring your safety and peace of mind.
EU Compliance: PPE Regulations and Safety Standards
At GIO SIOLUTIONS, we prioritize quality and compliance with EU regulations for all our single-use gloves and PPE products. This page outlines the key regulations and standards that govern our products, ensuring your safety and peace of mind.
Regulation on Personal Protective Equipment (PPE)
(EU) 2016/425
Regulation (EU) 2016/425 replaced Directive 89/686/EEC on April 21, 2018, setting new standards for PPE in the European market.
Key Changes
Harmonization of standards across the EU
Modified product categorization based on associated risks
Systematic CE Declaration of Conformity
5-year validity for new EU certificates
Extension of the regulation to cover PPE for private use against heat
PPE Categories
Category I: Simple PPE for minimal risk
Category II: Intermediate PPE for moderate risks
Category III: Complex PPE for serious risks that may cause very serious consequences such as death or irreversible damage to health
Note: All our PPE products fall under Category III, offering maximum protection.
Essential Health and Safety Requirements
Our PPE is designed and manufactured to meet the essential health and safety requirements laid out in Annex II of the regulation, including:
Ergonomics and comfort
Innocuousness of PPE materials
Protection against substances hazardous to health
Regulation on Personal Protective Equipment (PPE) (EU) 2016/425
Regulation (EU) 2016/425 replaced Directive 89/686/EEC on April 21, 2018, setting new standards for PPE in the European market.
Key Changes
Harmonization of standards across the EU
Modified product categorization based on associated risks
Systematic CE Declaration of Conformity
5-year validity for new EU certificates
Extension of the regulation to cover PPE for private use against heat
PPE Categories
Category I: Simple PPE for minimal risk
Category II: Intermediate PPE for moderate risks
Category III: Complex PPE for serious risks that may cause very serious consequences such as death or irreversible damage to health
Note: All our PPE products fall under Category III, offering maximum protection.
Essential Health and Safety Requirements
Our PPE is designed and manufactured to meet the essential health and safety requirements laid out in Annex II of the regulation, including:
Ergonomics and comfort
Innocuousness of PPE materials
Protection against substances hazardous to health
EN ISO 21-420 Standards
General Requirements
This standard establishes requirements for glove design, construction, and safety. Key aspects include:
Manufacturer identification
Size designation
Proper marking and information provision
EN ISO 21-420 Standards
General Requirements
This standard establishes requirements for glove design, construction, and safety. Key aspects include:
Manufacturer identification
Size designation
Proper marking and information provision
EN 374 Standards for Chemical and Micro-Organism Protection
EN 374-1:2016 (Chemical Risks)
Classifies gloves into three types based on chemical penetration resistance:
Type A: Highest level of protection
Type B: Medium level of protection
Type C: Basic level of protection
EN 374-5:2016 (Micro-Organism Risks)
Covers protection against bacteria, fungi, and viruses.
EN 374 Standards for Chemical and Micro-Organism Protection
EN 374-1:2016 (Chemical Risks)
Classifies gloves into three types based on chemical penetration resistance:
Type A: Highest level of protection
Type B: Medium level of protection
Type C: Basic level of protection
EN 374-5:2016 (Micro-Organism Risks)
Covers protection against bacteria, fungi, and viruses.
Regulation on Medical Devices (EU) 2017/745
This regulation ensures the safety and effectiveness of medical devices, including examination gloves.
EN 455 Standards for Medical Gloves
EN 455-1: Freedom from holes
EN 455-2: Physical properties
EN 455-3: Biological evaluation
EN 455-4: Shelf life determination
Regulation on Medical Devices (EU) 2017/745
This regulation ensures the safety and effectiveness of medical devices, including examination gloves.
EN 455 Standards for Medical Gloves
EN 455-1: Freedom from holes
EN 455-2: Physical properties
EN 455-3: Biological evaluation
EN 455-4: Shelf life determination
Food Contact Regulation (EU) 10/2011
Ensures the safety of materials and objects intended for food contact.
Food Contact Regulation (EU) 10/2011
Ensures the safety of materials and objects intended for food contact.
CE Marking and Unique Device Identification (UDI)
CE Marking
Indicates compliance with EU health, safety, and environmental standards.
UDI System
Enhances product traceability
Facilitates product recalls if necessary
Improves patient safety
CE Marking and Unique Device Identification (UDI)
CE Marking
Indicates compliance with EU health, safety, and environmental standards.
UDI System
Enhances product traceability
Facilitates product recalls if necessary
Improves patient safety
Conformity Assessment Procedures
Depending on the PPE category, different conformity assessment procedures apply:
Category I: Internal production control
Category II: EU type-examination followed by conformity to type based on internal production control
Category III: EU type-examination and either conformity to type based on internal production control plus supervised product checks or conformity to type based on quality assurance of the production process
Conformity Assessment Procedures
Depending on the PPE category, different conformity assessment procedures apply:
Category I: Internal production control
Category II: EU type-examination followed by conformity to type based on internal production control
Category III: EU type-examination and either conformity to type based on internal production control plus supervised product checks or conformity to type based on quality assurance of the production process
Quality Assurance and Professional Standards
Our Commitment to Excellence
At Gio-Solutions, we are deeply committed to maintaining the highest standards of quality and safety in all our PPE products. Our dedication to excellence is reflected in every aspect of our operations:
Rigorous Quality Control: We implement stringent quality control measures at every stage of production to ensure that all our products meet or exceed EU regulatory requirements.
Continuous Compliance: We stay up-to-date with the latest EU regulations and industry standards, continuously adapting our processes to ensure full compliance.
Professional Expertise: Our team consists of highly qualified professionals with extensive experience in PPE manufacturing and quality assurance.
Third-Party Verification: We regularly undergo independent audits and assessments to validate our quality management systems and product performance.
Transparency: We maintain comprehensive documentation of our quality processes and are always ready to provide necessary information to our clients and regulatory authorities.
Continuous Improvement: We are committed to ongoing research and development to enhance our products and processes, always striving for innovation and improvement.
Our unwavering focus on quality and compliance ensures that when you choose Gio-Solutions, you're selecting products that meet the most stringent safety and performance standards in the industry. We prioritize delivering consistent quality, regulatory compliance, and reliable service to support your business needs and enhance your reputation with your customers.
Quality Assurance and Professional Standards
Our Commitment to Excellence
At Gio-Solutions, we are deeply committed to maintaining the highest standards of quality and safety in all our PPE products. Our dedication to excellence is reflected in every aspect of our operations:
Rigorous Quality Control: We implement stringent quality control measures at every stage of production to ensure that all our products meet or exceed EU regulatory requirements.
Continuous Compliance: We stay up-to-date with the latest EU regulations and industry standards, continuously adapting our processes to ensure full compliance.
Professional Expertise: Our team consists of highly qualified professionals with extensive experience in PPE manufacturing and quality assurance.
Third-Party Verification: We regularly undergo independent audits and assessments to validate our quality management systems and product performance.
Transparency: We maintain comprehensive documentation of our quality processes and are always ready to provide necessary information to our clients and regulatory authorities.
Continuous Improvement: We are committed to ongoing research and development to enhance our products and processes, always striving for innovation and improvement.
Our unwavering focus on quality and compliance ensures that when you choose Gio-Solutions, you're selecting products that meet the most stringent safety and performance standards in the industry. We prioritize delivering consistent quality, regulatory compliance, and reliable service to support your business needs and enhance your reputation with your customers.
