8/5/20 - In-Stock, Shipping Now
These are US FDA-Cleared and Inspected N95 Respirators. Each shipment is processed, cleared, and released by the US FDA prior to delivery to EVIDENT. The FDA assists CDC NIOSH with the inspection of PPE imports into the US, click here for the MOU. Respirators attach with comfortable elastic ear loops. 10 respirators per box. 5 boxes per case of 50, 15 boxes per case of 150, 30 boxes per case of 300. 90 boxes per case of 900. These respirators are available for order here now. All PPE sales are final. EVIDENT, Inc. does not assume responsibility for use of this item. Not available for export. Non-Medical Grade masks. This is a Class II Device.
• N95 FDA-Cleared and Inspected
• 3-Layer Construction
• Adjustable Nose Piece
• Elastic Ear Loops
ONLY AVAILABLE FOR SALE TO LAW ENFORCEMENT AND GOVERNMENT CUSTOMERS
Payment by Credit Card or a NET10 Agency Purchase Order required on this item.
These N95 Respirators are US FDA Registered and Inspected. These are NOT the lower quality standard KN95 respirators.
FDA Registration: www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRL/rl.cfm?lid=661007&lpcd=MSH
Information about the MOU 225-14-017 between the FDA and CDC NIOSH for the regulatory oversight of N95 Respirators: www.fda.gov/about-fda/domestic-mous/mou-225-18-006
Definition from FDA: N95 Respirator – A disposable half-mask filtering facepiece respirator (FFR) that covers the user’s airway (nose and mouth) and offers protection from particulate materials at an N95 filtration efficiency level per 42 CFR 84.181. Such an N95 FFR used in a healthcare setting is regulated by FDA under 21 CFR 878.4040 (FDA product code MSH) and is either a class II device that is exempt from premarket notification requirements under section 510(k) of the FD&C Act or is a class II cleared device.
Click here for more information: www.fda.gov/media/136449/download