MAS+ takes pride in providing our customers with Personal Protective Equipment (PPE) that are manufactured under ISO 13485 and GMP manufacturing standards within our FDA registered manufacturing facilities. As a buyer, we understand that it is critical that the PPE products purchased are reliable
and are up to specification in every way possible. This is why MAS+ works diligently to ensure that all our products are tested with leading US and Europe-based accredited labs to guarantee that the required safety and quality standards are met.
When it comes to PPE, you have a lot of options to choose from and we want to show you why MAS+ is one of the best options available.
MAS+ Product Regulations in the US
When developing and manufacturing medical PPE, we make sure that we adhere to the appropriate US regulations. With that in mind, you can be assured that in purchasing MAS+ PPE, you will be getting certified product that you can trust. Procuring PPE that does not meet the mandatory standards and qualifications could potentially put your workforce and frontliners at risk which is why it is crucial that you source certified PPE that meets international standards from manufacturers such as MAS+.
We sell a variety of products from medical to consumer grade PPE to suit any type of customer.
Our gowns are tested and comply with the ANSI/AAMI PB70 standard which affirms the effectiveness of the PPE based on its liquid barrier performance. The information below will help you decide which PPE gowns align with your requirements and use.
- Level 1- Minimal Risk
- These gowns can be worn as cover gowns for visitors, in basic care, standard isolation or in a standard medical unit where a minimal level of fluid barrier protection is required
- Level 2 - Low Risk
- These gowns can be worn in situations where a low level of fluid barrier protection is required such as when drawing blood, suturing, while working in the ICU or in a pathology lab
- Level 3 - Moderate Risk
- These gowns can be worn during trauma cases or in an ER where a moderate level of fluid barrier protection is needed
- Level 4 - High Risk
- These gowns can be worn when the highest level of fluid and viral barrier protection is compulsory. For example, during long, fluid intense procedures, where pathogen resistance is necessary or when infectious diseases are suspected
MAS+ Product Regulations in Europe
Along with the US regulations, our products are also certified to be used in the EU. Purchasing products that are certified makes sure that you will not risk the health and safety of the user. MAS+ PPE conforms to the Personal Protective Equipment Regulation 2016/425 which lays down the requirements for the design and manufacture of PPE which ensures the protection of users.
Our products listed under the PPE Regulation 2016/425 are compliant with requirements for Category I and Category III products which cover minimal and high-risk scenarios. Having products that are compliant with the EU PPE regulation covers biological and chemical exposure that may commonly encountered in the industrial and healthcare industry. MAS+ PPE products are tested and certified by a notified body prior to selling to guarantee that you are buying effective products.
MAS+ offers products that conform to the Medical Device Regulation 2017/745 in addition to the PPE Regulation. This regulation ensures that the products supplied to Europe are compliant with the relevant standards of quality and safety for the intended use. Our medical devices listed under this regulation are compliant with Class I requirements. Additionally, all MAS+ products placed in the EU market have relevant CE marking which indicates that the product has been assessed and deemed to meet EU health and safety requirements.
Whether you are in the US or Europe, here at MAS+, we have tested and certified products that meet standards and regulations across the board. We care about you and your employees. We want them to be comfortable and safe. With MAS+ you can choose any of our PPE and be assured that it will provide the required level of protection to your employees.