Beyond The Mask: Breaking Down The Difference Between FDA, NIOSH, and CE Certification

Understanding the various certifications of respirators and facemasks offered across the healthcare market from FDA, to NIOSH, and CE can be a bit overwhelming to start. That’s why CovCare is helping consumers better clarify the mask and certification that best meets their needs.

One of the most frequently asked questions at CovCare over the past year since the company launched and became a leader in the medical supplies industry has been about the difference between the various certifications of facemasks and other PPE items: FDA, NIOSH, and CE. 

What do these certifications mean? What is the contrast between the three certifications? Why is it important to understand the difference in these certifications before purchasing your respirator or facemask? 

Regardless if you are looking to purchase N95 respirators, KN95 respirators or 3-ply disposable facemasks (for adults and children) , we help answer these questions and more as we go beyond the mask to learn the importance of these three types of certifications...

NIOSH (National Institute of Occupational Safety and Health): The National Institute of Occupational Safety and Health (NIOSH) is the governing body for respirator testing and certification and is responsible for approval of N95s intended for occupational use. The Occupational Safety and Health Administration (OSHA) determine the level of respiratory protection that is required for work environments and the appropriate NIOSH certified respirator is then used in that application. NIOSH certifies respirators based on their ability to filter out particulates, gases, and pathogens etc. Each respirator’s protection capability is determined when it is put up for NIOSH approval and this is where they receive their assigned protection factor (APF). Learn more about NIOSH approved N95 masks by CovCare and NIOSH certification here.

FDA (U.S. Food and Drug Administration): The U.S Food and Drug Administration (FDA) approves surgical masks that are to be used by healthcare professionals during surgical procedures. Because NIOSH approved respirators are also used by industrial workers, these are not tested by the FDA, as OSHA (Occupational Safety and Health Administration) requires NIOSH certification (learn more about FDA certification here). The FDA established three regulatory classes for medical devices to determine safety and effectiveness -- Class 1, Class II, and Class III.  

Class I – These devices present minimal potential for harm to the user and are often simpler in design than Class II or Class III devices. Examples include enema kits and elastic bandages. 47% of medical devices fall under this category and 95% of these are exempt from the regulatory process.

Class II – Most medical devices are considered Class II devices. Examples of Class II devices include powered wheelchairs and some pregnancy test kits. 43% of medical devices fall under this category.

Class III – These devices usually sustain or support life, are implanted, or present potential unreasonable risk of illness or injury. Examples of Class III devices include implantable pacemakers and breast implants. 10% of medical devices fall under this class.

Visit the FDA Approved N95 mask page here for a full list of premium-quality disposable Medical N95 face masks that are FDA approved N95 masks.

CE (Conformitè Europëenne): The Conformitè Europëenne (CE) mark is defined as the European Union’s (EU) mandatory conformity marking for regulating the goods sold within the European Economic Area (EEA) since 1985. The CE marking represents a manufacturer’s declaration that products comply with the EU’s New Approach Directives. These directives not only apply to products within the EU but also for products that are manufactured in or designed to be sold in the EEA. This makes the CE marking recognizable worldwide even to those unfamiliar with the EEA. Learn more about CE certification here and take a closer look at the CE Certified K95 masks carried by CovCare (which is also available in Black).

FDA vs. NIOSH Certification: Both the Food and Drug Administration (FDA) and the National Institute for Occupational Safety and Health (NIOSH) have responsibilities for evaluating and regulating respiratory protective devices (“respirators”) for health care workers. Respirators protect the user from respiratory hazards by either removing contaminants from the air (air-purifying respirators) or by supplying clean air from another source (air-supplying respirators). Respirators that are used in workplaces in the United States must be approved by NIOSH and meet standards and test results specified by regulation. Respirators used by healthcare workers are air-purifying respirators that generally fall into three types: (1) N95s; (2) re-usable respirators because they use a replaceable filter; or (3) powered air-purifying air respirators. It is also worth noting that FDA approval is not a requirement in healthcare, but is a recommendation.

FDA vs. CE Certification: The CE Mark in the European Union and the FDA-approval process in the United States both perform the same functions, namely assessing the safety and efficiency of new devices. The differences between these two certification approaches stem from a central divide: the U.S. approach assesses the device’s effectiveness as well as its risk of harm. The CE mark affirms simply that the product “meets high safety, health and environmental protection requirements”. Ideally then the U.S. approval would ensure not only that the product poses no harm to consumers, but also that it does what it claims to do. FDA approval always requires a full clinical trial or trials, whereas the CE Mark can be obtained through a clinical evaluation—a review of published data for existing equivalent devices. For a clinical evaluation, the only requirement is that the manufacturer conduct a post-market clinical follow-up study once the CE Mark is obtained. The CE Mark is recognized almost globally—in addition to being valid in all countries of the European Union. By comparison, FDA approval is valid only in the United States.

Whichever certification best meets your needs, CovCare has you covered when it comes to facemasks and respirators with NIOSH, FDA, and/or CE certification.