N95 NIOSH RESPIRATORS
We work closely with NIOSH (National Institute for Occupational Safety and Health) and the FDA (Food and Drug Administration) in the U.S., and with INSPEC in England, Apave in France to insure our products are up-to-date and meet all necessary U.S. and CE requirements. We also have product approvals in China, Russia, Korea, Japan, Australia and New Zealand.
Makrite surgical N95 respirators are designed to provide respiratory protection for users against non-oil based particles. This includes tuberculosis, bacteria, and various types of virus including COVID. Our surgical respirators actually offer protection greater than 99%. Our surgical masks protect wearers from particles generated by electrocautery, laser surgery, and other powered medical instruments. In addition, we have designed our surgical masks to be fluid resistant at a maximum of 160mm Hg. This prevents users from blood splash and other infectious materials. Our new surgical masks are tested and approved by Nelson Labs with the most recent FDA regulation updated in 2020. We have passed biocompatibility tests including cytotoxicity, skin sensitivity, and skin irritation to maximize wearer comfort. In addition, flammability and fluid resistance were also tested and approved to ensure the safety of users.
Makrite® 9500 Comfort Series
N95 Disposable Particulate Respirator
These masks are intended to be used for protection against solids, such as those from minerals, coal, iron ore, flour and certain other substances. They are extremely durable with a soft and comfortable inner surface,also have an adjustable nose piece and secured head straps to provide proper fit. These masks have a 510(K) number for the medical market and can be used TB situations as recommended by OSHA.
NIOSH Approval: TC-84A-5411 FDA 510 （K）：K020474
Makrite® SEKURA Comfort Series
N95 Disposable Particulate Respirator
This product has been tested and meets the NIOSH standard of N95. These mask are intended to be used for protection against solid, such as those from minerals, coal, iron ore, flour and certain other substance. The N95 Series are extremely durable with a soft and comfortable inner surface, with an adjustable nose piece and secured headstraps to provide a proper fit.
NIOSH Approval: TC-84A-7638
