Over 12,000 satisfied customersMedicom Safe+Mask® Sofskin Mask with Earloops, Type IIR, Fog Free
Product description
Professional medical-grade face mask designed for healthcare environments, featuring high filtration media and an integrated anti-fog system. This Type IIR mask includes an anatomical design with a specialized vapor barrier strip to prevent glasses fogging, making it ideal for extended medical and dental procedures.
Product Features:
- High filtration media with glass fiber-free construction
- Integrated nasal bar with anti-fog strip
- Anatomical folding design to minimize facial leakage
- Two wide elastic bands for enhanced comfort
- Vapor barrier system for glasses fog prevention
Technical Details:
- Medical Device Class I
- Type IIR medical mask classification
Standards:
- EU Regulation 2017/745 on Medical Devices
- CE certified
- MD (Medical Device) compliant
Recommended Applications:
- Medical procedures
- Dental procedures
Indicates the filtration standard and hazard protection level, from basic particle filtering (P1/FFP1) to high-efficiency gas and vapor protection (A2, B2, etc.).
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.
Indicates the exterior hue of the respirator, which may signify specific protection types, enhance visibility in workplaces, or meet industry color-coding standards.
Indicates the composition of filtering media and outer shell, affecting filtration efficiency, comfort, durability, and suitability for specific contaminants or environments.
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.
- Respiratory Protection
- Medical Protection
- Antimicrobial Protection
- Clean Room
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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.
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.
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 4,74 €
Brand minimum 200,00 €
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Delivery time: 5 business days
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