Kolmi Softex Mask with Earloop, Type IIR
Product description
Advanced medical mask designed with superior filtration capabilities against bacteria, particles, and viruses, featuring specialized testing for BFE, PFE, and VFE protection. The mask incorporates exclusive Origami fold technology and Smile welding for enhanced facial fit, while the Softex technology inner layer ensures comfort during prolonged wear. Clinically proven to reduce seasonal allergy symptoms and improve quality of life for individuals with pollen allergies.
Product Features:
- Exclusive Origami fold and Smile welding for optimal face fit
- Softex technology inner layer for extended wear comfort
- Protection against biological fluid splashes
- Effective bacterial, particle, and viral filtration
- Hypoallergenic construction
Technical Details:
- Medical Device Class I certification
- Type IIR medical mask classification
- Tested for BFE, PFE, and VFE effectiveness
- Clinically tested by AFPRAL for allergy reduction
Standards:
- EU Regulation 2017/745 on Medical Devices
- CE certified
- MD Class I
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 mask's coverage area (full face or half face), affecting protection level, visibility, and compatibility with other safety equipment.
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.
- Respiratory Protection
- Medical Protection
- Antimicrobial Protection
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Standards and labels
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.
PPE stands for "personal protective equipment." PPE Category 1 refers to equipment that is simple and easy to use, and has a lower level of risk. Examples of PPE Category 1 include gloves, goggles, and simple respirators. In Europe, PPE Category 1 must meet certain safety standards set by the European Union. This means that it must be designed and manufactured to protect the user without causing harm. Companies that make or sell PPE must prove that it meets these standards.
Standards have not been specified
Medicom delivery terms
Free delivery when you order more than 150,00 € from Medicom
Supplier shipping fee 6,33 €
Brand minimum 200,00 €
Price available on request
Shipping fee is 6,33 € for orders under 150,00 €
A carton contains 16 packages (800 pieces)
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Medicom
Delivery time: 5 business days
Orders from 200,00 €
Supplier shipping fee 6,33 €
Free shipping on orders over 150,00 €



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