Face masks serve as protective barriers covering the mouth and nose, typically composed of non-woven fabric. Their primary function is to mitigate the transmission of infectious microorganisms, including viruses and bacteria.
From a regulatory perspective, various types of face masks exist, each distinguished by specific classification criteria. In Costa Rica, face masks are categorized into three distinct classifications based on their intended use.
Medical use face masks
These kinds of face masks are often disposable, single use and typically multilayer products such as three-layer folded, N95 or KN95. They are mainly used in hospitals, clinics and research centers by healthcare professionals to avoid contamination from and for the patients or clinical samples. All protective masks for medical use are considered by the Ministry of Health as Class I medical devices.
Non-medical use face masks
Other types of face masks, such as fabric or textile masks, are commonly used outside healthcare settings. This category includes disposable or washable face masks made from woven or non-woven materials for general use. These products are not regulated as medical devices, provided they are not labeled or advertised with medical claims, such as germ-killing properties or other characteristics associated with medical-grade face masks.
Protective equipment face masks
Finally, we have the third kind of face masks, that includes respiratory protectors for filtrating, not only microorganisms, but also dust particles or chemicals. In this classification, we can include N99, KN99 or face masks exclusively for industrial use for the protection of the airway against substances immersed in manufacturing processes.
Those products are not considered medical devices and thus, are not subject to regulations by the Ministry of Health. However, they may comply with Costa Rican Official Norms.
As a conclusion, the classification and regulation of face masks in Costa Rica depends on their characteristics and intended use. If you are interested in importing and selling face masks and have additional inquiries, please contact us at contact@veraqueconsulting.com or check our guidelines.
