KM ACT KN95 Respirator Face Mask with Braided Cloth Earloops & Flexible Nosepiece, Four-Layer Protection (Box of 1000)
FDA Coronavirus Product Notice for KN95 Respirator Masks
On Friday, April 3rd, 2020, in response to continued respirator mask shortages, the FDA issued a new Emergency Use Authorization (EUA) for Non-NIOSH approved respirators made in China, which makes KN95 respirators eligible for authorization if certain criteria are met, including evidence demonstrating the respirator is authentic. (See "Documents sub-tab below to view PDF Certificates of FDA registration.)https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-daily-roundup-april-3-2020
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- FDA Approved Substitute N95 Face Mask * FDA Certified (Owner/Operator Number: 10067890) * CE Certified (See "Documents Sub-Tab Below)
- KN95 Respirator Mask provides 4-layer, filtered protection with folded design.
- Mouth Layer: Moisture-proof non-woven cloth / 1st Inner Layer: Hot-Air Cotton Filter / 2nd Inner Layer: Melt-Blown PP Cloth / Outer Cover: Moisture-proof, non-woven fabric shell.
- Form Fitting Facemask: A flexible metal nosegaurd provides a snug, comfortable fit and reduces skin irrtation. Soft, braided, stretchable earloop bands secure the mask snugly to the face which ensures comfortable long-term use of the KN95 face mask.
- Lightweight, Disposable, Superior Protection: Vertical, folded design and lightweight construction. KN95 masks are breathable and disposable, providing significantly more protection than standard 3-ply earloop facemasks. (See Chart Below)
- Box of 1000 (10 Inner Packs of 100 Masks/Box)
- Manufacturer Part No: KMA-KN95
PLEASE NOTE: Product images and descriptions may not exactly represent the product. Prior to making your purchase, please confirm that the manufacturer part number shown above matches the product you seek. Returns are not allowed for such differences if the correct manufacturer part number is shipped.
Details
On Friday, April 3rd, 2020, the FDA issued an emergency use authorization for KN95 masks. Regulated by the Chinese government (China Standard GB2626-2006), these Chinese manufactured KN95 respirator masks are almost identical in performance to NIOSH approved N95 respirator masks. The masks are worn for respiratory protection by hospital employees, first responders, and other institutions. The manufacturer has completed the FDA Establishment Registration and Device Listing.
Downloads Available: Please see "Documents" sub-tab above to download this Chinese manufacturer's Establishment Registration & Device Listing for Huaxun Electronic Technology, Ltd., China.
Downloads Available: Please see "Documents" sub-tab above to download this Chinese manufacturer's Establishment Registration & Device Listing for Huaxun Electronic Technology, Ltd., China.
Documents & Videos
On Friday, April 3rd, 2020, the FDA issued an emergency use authorization for KN95 masks. Regulated by the Chinese government (China Standard GB2626-2006), these Chinese manufactured KN95 respirator masks are almost identical in performance to NIOSH approved N95 respirator masks. The masks are worn for respiratory protection by hospital employees, first responders, and other institutions. The manufacturer has completed the FDA Establishment Registration and Device Listing.
Downloads Available: Please see "Documents" sub-tab above to download this Chinese manufacturer's Establishment Registration & Device Listing for Huaxun Electronic Technology, Ltd., China.
Downloads Available: Please see "Documents" sub-tab above to download this Chinese manufacturer's Establishment Registration & Device Listing for Huaxun Electronic Technology, Ltd., China.