Kolmi Softex Mask with Earloops, Type II Kids, Blue
Product description
This medical-grade face mask is specifically designed for children aged 5 to 12 years, featuring exclusive Origami folding and Smile welding technology for optimal facial fit. The mask incorporates a hypoallergenic Softex inner layer that provides lasting comfort for sensitive skin while effectively protecting the environment from droplets.
Product Features:
- Polypropylene construction
- Origami folding and Smile welding for enhanced fit
- Soft, non-irritating Softex inner layer
- Hypoallergenic materials
- Designed for children aged 5-12 years
Technical Details:
- Medical Device Class I
- Type II medical mask
- Non-wearing material suitable for prolonged use
Standards:
- EU Regulation 2017/745 on Medical Devices
- CE certified
- MD (Medical Device) compliant
Indicates the exterior hue of the respirator, which may signify specific protection types, enhance visibility in workplaces, or meet industry color-coding standards.
Defines the structural design of the respirator (cup, flat, or fold), affecting facial fit, seal effectiveness, comfort during extended wear, and storage convenience.
Defines the mask's coverage area (full face or half face), affecting protection level, visibility, and compatibility with other safety equipment.
Defines how the respirator attaches to your face, affecting comfort, seal quality, and ease of use during extended wear periods.
Indicates the composition of filtering media and outer shell, affecting filtration efficiency, comfort, durability, and suitability for specific contaminants or environments.
Indicates the filtration standard and hazard protection level, from basic particle filtering (P1/FFP1) to high-efficiency gas and vapor protection (A2, B2, etc.).
- Respiratory Protection
- Medical Protection
- Antimicrobial Protection
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Standards and labels
Test results
Service Reliability PassedEN ISO 9001:2015 is a globally recognized standard that specifies requirements for a quality management system (QMS), focusing on numerous aspects of quality management in organizations, aiming to enhance customer satisfaction through the effective application of the system. The 'Service Reliability' with a 'Passed' designation indicates that an organization has successfully demonstrated its ability to consistently provide services that meet customer and regulatory requirements while aiming for continual improvement. This assessment involves evaluating various elements of the QMS including service planning, execution, and monitoring, to ensure reliability and performance consistency. The practical implications for organizations that pass this aspect of the standard are significant; it establishes them as reliable providers in their industry, enhancing customer trust and satisfaction, and potentially leading to increased business and a competitive advantage.
ISO 13485:2016 is a standard that specifies requirements for a quality management system for the design and manufacture of medical devices. It includes requirements for how companies should design, implement, maintain and improve their quality management system to ensure that their medical devices are safe and effective. Test results can include information on how well the quality management system is functioning, how well it is being followed, and how effective it is in preventing defects. The standard also includes requirements for how the company should document and record their quality management system performance and continuously improve it.
Test results
Medical Management PassedThe ISO 13485:2016 standard is specifically tailored for medical device manufacturers and aims to ensure the quality and safety of medical devices throughout their production and lifecycle. A test result of Passed in the context of the ISO 13485:2016 standard signifies that the medical device manufacturing management system under assessment has successfully met all regulatory and safety requirements stipulated in the standard. This encompasses rigorous evaluations of the manufacturer's quality management system, including processes like risk management, regulatory compliance, and effective process control. The assessment involves auditing processes such as document review, facility inspection, and staff interviews, to verify the adequacy and effectiveness of the quality management system. Meeting the ISO 13485:2016 requirements assists manufacturers in achieving and maintaining regulatory compliance and ensures that their products consistently meet user needs and applicable regulatory standards, which is crucial for entry and continued presence in global markets.
EN ISO 11737-1:2006 is a standard that tells how to make sure medical devices are cleaned and sterilized properly before they are used on people. It includes rules for the methods used to clean and sterilize the device and how to test to make sure the cleaning and sterilization process was successful. Test results should show that the device is clean and free from harmful microorganisms. It was published in 2006.
CE Marking is a label that shows a product meets certain safety and environmental standards set by the European Union. To get the CE Marking, a company must test and certify their product meets these standards. CE Marking is required for many products sold in the EU, including electronics, machinery, toys and medical devices. It helps ensure that products are safe for consumers and the environment, and allows for easy trade within the EU.
Medicom delivery terms
Free delivery when you order more than 150,00 € from Medicom
Supplier shipping fee 5,00 €
Brand minimum 200,00 €
54,04 €
Price per 12 packages (600 pcs)
0,09 € / piece
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Medicom
Delivery time: 4 business days
Orders from 200,00 €
Supplier shipping fee 5,00 €
Free shipping on orders over 150,00 €



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