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FDA Approved CDC Listed KN95 Masks...What to know

FDA Approved KN95 CDC Listed

FDA Approved CDC Listed KN95 Masks

Ever since the outbreak of the coronavirus 2019 (Covid-19), there has been widespread use of different personal protective equipment (PPE). This is quite evident in the US’s case, where there has been an increased use of PPE. Mostly, the N95 and KN95 Filtering Facepiece Respirators (FFRs). With the increase and high demand for FFR products, both Healthcare Personnel (HCP) and consumers need to understand which are being approved and authorized for use.

In the US, the National Institute for Occupational Safety and Health (NIOSH) provides a testing and approval program which guarantees respirators used in the workplace conforms to certain standards agreed upon by the Food and Drug Administration’s (FDA) Emergency Use Authorization (EUA), and the Center for Disease Control (CDC). All NIOSH approved and certified respirators such as the N95 and FDA Approved KN95 can be found on an online database list - EUA Appendix A, which is highly recommended for healthcare personnel, emergency, and first response workers. FDA publishes EUA lists in times of dire need and mainly deals with regulation of medical devices to assist the medical community.

FDA Appendix A KN95 Masks for medical and civilian use

Protectly is proud to be a direct authorized distributor for Jiangsu Sanfo Outdoor Products (FDA Appendix A approved manufacturer). Sanfo KN95 masks have passed the strictest requirements to be approved and added to the FDA Appendix A list of KN95 masks. Due to the high demand and relative shortage of N95 masks in the country, the FDA has updated a separate Emergency Use Authorization (EUA) that applies to KN95 masks. The separate FDA EUA paves a way to access non-NIOSH-approved disposable FFRs, thereby providing healthcare personnel access to more medical devices.

Although the KN95 masks might not be certified by NIOSH, they are approved separately by the FDA through the carefully selected list of manufacturers in the Appendix A list and possess highest quality as well as bacterial/particle filtration efficiency.

Certified KN95 Masks

While FDA Appendix A CDC Approved KN95 masks and manufacturers are aimed at easing the burden of sourcing respirators for the medical community, also provides access to Certified Authentic KN95’s for general public and civilian use. The standard certified authentic KN95 masks that are not on the Appendix A are approved to be sold by FDA for general, everyday use. They have passed all of the same quality testing and screening in order to make it into our supply chain. They are more affordable than the Appendix A KN95 masks and made in FDA-Registered facility. We fully stand by the quality of both the regular and Appendix A KN95’s and guarantee your total satisfaction 100%.