Personal protective equipment (PPE) is a daily necessity in many occupations, including healthcare, and it is important to understand their regulatory requirements.

Navigating Regulatory Requirements for Medical Personal Protective Equipment

Doctors and nurses use face masks, gloves, surgical gowns, etc. to protect themselves and patients from infection and the spread of disease, and during the height of the COVID-19 pandemic, PPE shortages reached critical lows. Countries like the United States that import most of their PPE supply struggled to obtain enough masks, gloves, and gowns to protect their healthcare professionals and patients. The US Food and Drug Administration (FDA) implemented Emergency Use Authorizations (EUAs) to expedite the import of essential PPE. When the public health emergency (PHE) expired, many PPE manufacturers had to pull their products from the US market or navigate formal regulatory pathways to continue selling their products. In this article, we’ll review regulatory requirements for PPE products in the US and Europe.

Is Your PPE a Medical Device?

In many cases, PPE intended for use in a healthcare setting will be regulated as a medical device. Some PPE products that are chemical compounds, gels, topical biocides, etc. (e.g., soaps, hand sanitizers) may even be considered drugs or combination products. If your product is considered a medical device, you must follow the regulatory pathway required for devices with your product’s risk classification. Risk classification will largely be determined by the product’s intended use and the level of risk to the patient or user if the product fails to fulfill its intended purpose. The indications for use, along with other product characteristics also dictate the risk class for different devices.  

Non-medical PPE–such as N95 paint or dust masks/respirators, construction helmets, etc.–may be subject to regulatory oversight in some markets but are not considered medical devices. For example, many face coverings and N95 respirators are manufactured for use in industrial or construction settings. In the US, this type of N95 respirator is regulated by the Personal Protective Technology Laboratory (NPPTL) in the National Institute for Occupational Safety and Health (NIOSH), which is under the Centers for Disease Control and Prevention (CDC). 

US Requirements for Healthcare PPE

FDA regulates most common PPE products as medical devices. FDA risk classifications vary, though most PPE products are Class I or Class II. 

Gloves 

Gloves used in a healthcare setting are often Class I devices under the FDA. Specific requirements (such as biocompatibility testing) can vary depending on the glove materials (e.g., latex vs. vinyl), indications for use (e.g., surgical vs. dental gloves, etc.), and specialties (e.g., chemotherapy gloves are Class II devices requiring a 510(k)). FDA recommends using test methods outlined ISO 10993 for biocompatibility. Testing standards for other parameters are voluntary. 

FDA does not regulate gloves used during routine cleaning in medical facilities. However, gloves used while cleaning areas or items that may be contaminated with patient waste or fluids are considered medical gloves and should meet the necessary regulatory requirements. 

Masks 

FDA regulates face masks, including surgical masks, face barriers and covers, and N95 respirators, as medical devices when they are intended for a medical purpose or use in a healthcare setting. In general, they are Class II devices, though some may be exempt from 510(k) requirements depending on their characteristics. ASTM F2100-19 is the standard used in the US to test materials performance used in medical face masks. Based on test results, medical face masks are categorized into Levels 1, 2, or 3 with increasing levels of barrier protection. 

Medical gowns 

Medical gowns are regulated as medical devices with FDA classifications ranging from Class I to Class II. Product characteristics (e.g., sterile or non-sterile, reusable or single use, the level of protection provided, etc.) and whether they are intended for use in a surgical setting influence the risk class as well as 510(k) requirements. For instance, non-surgical isolation gowns intended for use in low-risk treatment scenarios are considered Class I medical devices and are exempt from premarket review. However, all surgical gowns are considered Class II devices and require a 510(k). 

Medical gowns in the US must be tested using methods defined by ANSI/AAMI PB70:2012 to assess liquid barrier performance. ANSI/AAMI PB70:2012 classifies gowns into four levels according to the protection level and risk scenario:  

Europe Requirements for Healthcare PPE

Regulation (EU) 2016/425 outlines regulatory requirements for PPE sold in Europe. Like medical devices and IVDs, PPE products must acquire CE Marking before they can be legally marketed. However, PPE intended for medical use and/or use in a healthcare setting are often classified as medical devices. In this case, medical PPE manufacturers would look to the EU Medical Devices Regulation (2017/745) for CE Marking requirements according to their product’s risk classification. Depending on the characteristics of your product, it may be possible to obtain dual certification as a medical device and as PPE (under Regulation (EU) 2016/425). 

Gloves 

EU classification for medical gloves can vary considerably based on the characteristics and intended use. Non-sterile examination gloves are Class I devices, while sterile examination gloves are Class Is. Surgical gloves, however, are considered invasive medical devices and are generally ruled as Class IIa. 

Medical gloves sold in Europe should meet the requirements for testing outlined in the EN455 series of standards. EN455 comprises four parts that address various aspects of glove quality, including testing for freedom from holes, physical properties, biological evaluation, and shelf–life determination. 

Masks 

According to the MDR classification rules, medical face masks are classified according to Rule 1 for non-invasive medical devices. Non-sterile face masks are considered Class I devices, which allows the manufacturer to perform a self-assessment conformity procedure. Sterile face masks are considered Class Is, which requires notified body involvement for the conformity assessment and documentation validation. Manufacturers should refer to testing processes for EN14683:2019 for barrier protection, splash resistance, and fluid resistance. 

Medical gowns 

Medical gowns including sterile and non-sterile isolation gowns, as well as surgical gowns, are considered Class I medical devices in Europe.  

EN13795-1:2019 is the standard that defines testing, as well as manufacturing and performance specifications for medical gowns. It categorizes gowns into two levels: Standard Performance – Low to medium risk of exposure and High Performance – High risk of exposure. 

Learn More About What is Required for Personal Protective Equipment with MedEnvoy

In most cases, personal protective equipment must comply with medical device regulations and conformity assessment requirements before they can be marketed for use in a healthcare setting. If you’re a PPE manufacturer looking to expand into healthcare, MedEnvoy can help you navigate the often-challenging process of bringing a medical device to market. We will determine if your PPE device meets regulatory requirements to qualify as a medical device, determine its risk classification in your target markets, and define the roadmap for complying with market regulations. 

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