Medicom Safe+Mask® Sofskin Mask with Earloops, Type IIR Fog Free, Levender

Medicom
visit storeProduct description
Medical-grade face mask designed for healthcare professionals featuring high filtration media and an integrated anti-fog strip to prevent glasses from fogging. The mask incorporates an anatomical folding design with an integrated nasal bar to minimize facial leaks, while two wide elastics ensure comfort during extended wear.
Product Features:
- High filtration media without glass fibres
- Integrated nasal bar with anti-fog strip
- Anatomical folding design to minimize leaks
- Two wide elastics for enhanced comfort
Technical Details:
- Medical mask type IIR
- Glass fibre-free filtration system
- Anti-fog vapor barrier system
Standards:
- EU Regulation 2017/745 on Medical Devices
- MD Class I certification
- CE marked
- Type IIR medical mask classification
Recommended Applications:
- Dental procedures
- Medical environments
The visual appearance of the respirator, which may affect workplace compliance, visibility requirements, and professional appearance.
Indicates the level and type of filtration provided, determining what contaminants the respirator protects against and the percentage of particles filtered.
Determines the physical form of the mask, affecting comfort, breathing space, storage convenience, and how well it seals against your face.
Determines the coverage area and design of the respirator, such as full face or half face, affecting protection level and compatibility with other safety equipment.
Elastic straps provide a snug, comfortable fit that adapts to your head, ensuring reliable protection.
Effortless earloops provide quick, comfortable wear for convenient protection.
The construction materials used in the respirator's filter, face piece, straps, and components, affecting filtration efficiency, comfort, and durability.
- Clean Room
- 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.
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.
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.
Medicom delivery terms
Free delivery when you order more than 150,00 € from Medicom
Supplier shipping fee 6,68 €
Brand minimum 200,00 €
Price available on request
Shipping fee is 6,68 € for orders under 150,00 €
A carton contains 100 packages (5 000 pieces)
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