Kolmi Softex Tie-on Mask, Type IIR, Blue
Product description
This Type IIR medical mask provides dual protection by preventing droplet transmission from the wearer while offering protection against biological fluid splashes. Featuring comprehensive filtration against bacteria, particles, and viruses, the mask incorporates exclusive Origami folding technology for enhanced fit and comfort. The hypoallergenic design with Softex technology inner layer ensures prolonged wearing comfort and minimizes facial irritation.
Product Features:
- Origami folding system for optimal face fit
- Softex technology inner layer for extended comfort
- Protection against biological fluid splashes
- Hypoallergenic construction
- Suitable for use with facial hair
Technical Details:
- Tested for bacterial, particle, and viral filtration (BFE, PFE, & VFE)
- Medical Device Class I classification
- Type IIR medical mask specification
Standards:
- EU Regulation 2017/745 on Medical Devices
- CE certified
- MD (Medical Device) certified
Defines the mask's coverage area (full face or half face), affecting protection level, visibility, and compatibility with other safety equipment.
Indicates the exterior hue of the respirator, which may signify specific protection types, enhance visibility in workplaces, or meet industry color-coding standards.
Offers a customizable and secure fit by tying around the head. Ideal for extended use, providing comfort without pressure on the ears.
Offers a snug, adaptable fit due to its inherent stretch. Conforms comfortably to the head, ensuring secure placement for reliable respiratory protection.
Indicates the filtration standard and hazard protection level, from basic particle filtering (P1/FFP1) to high-efficiency gas and vapor protection (A2, B2, etc.).
Defines the structural design of the respirator (cup, flat, or fold), affecting facial fit, seal effectiveness, comfort during extended wear, and storage convenience.
- Antimicrobial Protection
- Medical Protection
- Clean Room
- Respiratory Protection
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Standards and labels
EN 14683:2019 + AC:2019 is a European standard that specifies the performance requirements and test methods for surgical face masks. The standard defines the mask's ability to filter bacteria and particles, as well as its breathability. The mask must also pass tests for flammability, splash resistance, and biocompatibility. The mask must pass all the test to be certified as a surgical mask.
Test results
Bacterial Filtration Type IIRThe Bacterial Filtration Efficiency (BFE) result for the Type IIR mask according to EN 14683:2019+AC:2019 indicates the mask's ability to block bacterial particles from passing through the material. For a Type IIR mask, this test evaluates whether the mask can maintain a BFE of ≥98%. The practical implication of this result for procurement professionals is that when they choose Type IIR masks complying with EN 14683:2019+AC:2019, they are selecting masks that offer a high level of bacterial filtration, suitable for environments where exposure to bacteria is a concern, such as medical facilities.
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.
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.
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.
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 5,00 €
Brand minimum 200,00 €
27,58 €
Price per 6 packages (240 pcs)
0,11 € / 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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