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US Regulations

US Regulations

Guidance on regulatory requirements for face masks manufacturers in the US

You are planning to launch your production line of face masks and you are seeking information about regulations, marking, or any other requirements to operate your activity in the US. Here is MKEnX's guide from our advisers to provide you with the relevant information.
 
The US regulations about face masks are divided into medical (medical masks) and industrial (respirators) use.

Medical Masks

Medical face masks protect the wearer’s face from contact with body fluids, bacteria and various particles. 

Regulations

Medical face masks are considered as medical devices and regulated by the medical device regulations of the US. Such regulations define the legal obligations in order to ensure that medical face masks will provide the minimum level of protection against intended risks. Specific requirements by classification are cited in the referenced performance standard.

In the regulations of the US, medical masks and medical surgical masks are differentiated. 

Medical Masks

 

Medical Surgical Masks

Marking

Classified as either a Class 1 or Class 2 medical device, in the US medical masks must meet the labelling requirements of the relevant regulations. Some medical masks may be classified as “source control” per Emergency Use Authorization. 

 

Respirators 

Designed to provide the wearer with respiratory protection against inhalation of a hazardous atmosphere, respirators are designed for the efficient filtration of airborne particles.

Regulations

Respirator regulations are the jurisdiction of the FDA, and define the legal obligations to ensure that respirators provide the minimum level of protection against intended risks. Specific requirements by classification will be contained within regulation or cited in referenced performance standard.
 
In the regulations of the US, respirators and surgical respirators are differentiated. 

Respirators

 

Surgical Respirators

 

Marking

● The National Institute for Occupational Safety and Health (NIOSH) specifies minimum approval requirements for respiratory protective devices in Title 42 Code of Federal Regulations (CFR) Part 84.

● NIOSH approval labels are described in 42CFR84 (§84.33), and the information they provide, and their locations differ depending on the respirator type. These labels are referred to as “entire” or “abbreviated” (§84.33[e]). However, these labels do not identify the approved respirator’s complete configuration of components.

Source: SGS Protective Face Mask Testing & Certification