Kolmi Softex Mask with Earloops, Type II
Product description
This Type II medical mask provides comprehensive protection against droplets, bacteria, particles, and viruses, with verified BFE, PFE, and VFE testing. The mask features an exclusive Origami fold design and Smile welding technology for enhanced facial fit, while the Softex technology inner layer ensures comfort during extended wear periods. Hypoallergenic properties make it suitable for sensitive skin and prolonged medical use.
Product Features:
- Exclusive Origami fold and Smile welding for optimal face fit
- Softex technology inner layer for reduced facial irritation
- Suitable for extended wear, including with facial hair
- Hypoallergenic construction
Technical Details:
- Medical Device Class I classification
- Protection against droplets, bacteria, particles, and viruses
- Tested for BFE, PFE, and VFE effectiveness
Standards:
- EU Regulation 2017/745 on Medical Devices
- Medical Device (MD) Class I
- CE certified
- Type II medical mask classification
Indicates the filtration standard and hazard protection level, from basic particle filtering (P1/FFP1) to high-efficiency gas and vapor protection (A2, B2, etc.).
Indicates the composition of filtering media and outer shell, affecting filtration efficiency, comfort, durability, and suitability for specific contaminants or environments.
Easy to use and quick to put on, earloops offer a convenient fit. Ideal for applications requiring frequent donning and doffing of the respirator.
Offers a snug, adaptable fit due to its inherent stretch. Conforms comfortably to the head, ensuring secure placement for reliable respiratory protection.
Defines the structural design of the respirator (cup, flat, or fold), affecting facial fit, seal effectiveness, comfort during extended wear, and storage convenience.
- Medical Protection
- Respiratory Protection
- Antimicrobial Protection
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Standards and labels
EN ISO 11737-1:2018/A1:2021 is a standard that defines how to test the sterilization of medical devices. It includes requirements for the methods used to sterilize the device and how to test to make sure the sterilization process was successful. Test results should show that the device is free from harmful microorganisms and safe for use. It was amended in 2021 which is why it has A1 at the end of the name.
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 9001:2015 is a standard that sets out the requirements for a quality management system (QMS). It is a set of guidelines that organizations can follow to ensure that they meet customer requirements and enhance customer satisfaction. The standard is based on the plan-do-check-act model and focuses on continuous improvement. It covers the design, development, production, installation, and servicing of products. Organizations can get certified to this standard, which means that they have been independently audited and found to meet the requirements of the standard. The certification process includes regular audits to ensure that the organization continues to meet the standard's requirements.
Test results
Service Reliability PassedCE 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.
MD stands for "Medical Device." It refers to any instruments, apparatus, machines, implants, or other similar or related articles that are intended to be used for human beings for the purpose of diagnosis, prevention, monitoring, treatment or alleviation of disease, injury or disability. In Europe, a MD Label is a special label that must be on all Medical Devices that are sold or used in the European Union (EU). The label must include information about the product, such as the name of the manufacturer, the intended use of the product and CE mark. To be able to sell or use a Medical Device in the EU, the device must meet certain standards and requirements set by the European Union and notified body.
Medicom delivery terms
Free delivery when you order more than 150,00 € from Medicom
Supplier shipping fee 6,68 €
Brand minimum 200,00 €
73,08 €
Price per 16 packages (960 pcs)
0,076 € / piece
Shipping fee is 6,68 € for orders under 150,00 €
A carton contains 16 packages (960 pieces)
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Medicom
Delivery time: 4 business days
Orders from 200,00 €
Supplier shipping fee 6,68 €
Free shipping on orders over 150,00 €



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