Product & Manufacturer Details

These 3M 9502+ vertical folding masks with headbands are available in a standard size.

Labeling

Disclaimer: The 3M 9502+ is a NIOSH KN95 respirator.
The 9502+ is manufactured by 3M China Co. Ltd. per the GB 2626-2006 standard. It has recently attained CDC NIOSH approval (as an N95 respirator) in the United States, but may have been manufactured and packaged prior to obtaining CDC NIOSH approval, and therefore may not yet bear updated NIOSH labeling. Therefore, it may not be suitable for your medical needs. Please read the following thoroughly before purchasing this mask:

What is a NIOSH KN95?

• KN95 means that it was produced in China for the domestic market, and therefore adheres to Chinese regulations
• NIOSH means it was tested by the CDC’s NIOSH and passed its standards for a NIOSH-approved N95 respirator.
• Click here for a comparison of regulatory standards.
• NIOSH KN95 are masks that pass NIOSH standards but are not typically sold into the American market, and are therefore labeled KN95 given their target (domestic Chinese) market

What are NIOSH and the FDA?

• NIOSH is the National Institute for Occupational Safety and Health. It is responsible for conducting research and making recommendations for the prevention of work-related injury and illness. Part of NIOSH’s role is to issue certifications for N95 filtering facepiece respirators, meaning the mask filters at least 95% of airborne particles. Any authentic mask that carries the “N95” certification has been approved by NIOSH.
• FDA is the U.S. Food and Drug Administration. Part of its role is The Emergency Use Authorization (EUA) authority, which allows it to “help strengthen the nation’s public health protections against CBRN threats by facilitating the availability and use of MCMs needed during public health emergencies,” which includes approving masks for emergency use during the COVID-19 pandemic.

NIOSH approvals

The 3M 9502+ is a NIOSH approved respirator (84A-8637) which is manufactured in China. The following links are certifications by the CDC’s NIOSH that approve it as a NIOSH-certified N95 respirator.

CDC NIOSH-approved N95 FFRs (3M)
NIOSH approval documentation (84A-8637)

FDA approvals

The 3M 9502+ is an FDA EUA-approved Appendix A mask, which includes “non-NIOSH respirators authorized by this Umbrella EUA for emergency use during the COVID-19 public health emergency.” As of April 3, 2020, the 3M 9502+ mask is a part of Appendix A. Notably, however, there is a contradiction between the FDA categorization of the 3M 9502+ mask as an “Authorized Imported, Non-NIOSH Approved Respirators Manufactured in China” and NIOSH’s categorization of the 3M 9502+ mask as a “NIOSH approved respirator (84A-8637) which is manufactured in China.” Therefore, we hesitate to label the 3M 9502+  explicitly as a NIOSH N95 respirator, even though the issuing entity, NIOSH, has approved it as such.

FDA EUA approved (non-NIOSH)

Storage Conditions & Shelf Life

• Shelf life of unopened product is 5 years from date of manufacture
• Temperature Range: -4°F to +86°F
• Maximum Relative Humidity: <80%