N95 Surgical Flat Fold Disposable Respirator Manufactured in North America. Alpha Medical Manufacturing was formed and developed and achieved certification for a North American Manufactured device as a result of the shortage encountered at the start of the Covid Pandemic. Alpha produces a high quality, fitted respirator for protection of the wearer against exposure to dusts fumes and mists encountered in the environment. The surgical classification means additional testing is performed over the standard NIOSH particular respirator making it suitable for prevention of exposure to bodily fluids in the surgical operating theater, this additional testing includes flammability, bacterial filtration efficiency, and bio compatibility to ensure the product does not create irritation or sensitization to the wearers skin. In addition the CSA certification requires head band strength testing as well as fit testing of the respirators against a standard to ensure that the product fits 70% of the target face sizes. KN respirators and standard NIOSH particulate respirators are not fit tested as only respirators with secure fits are able to provide maximum protection against exposure. Alpha respirators meet all of the standards and are tested by lot as per the military standards in the facility to ensure high quality product is released for sale and that lot tracking and recall procedures are in place as per the companies quality management program.
The respirator is manufactured from 100% high quality polypropylene non-wovens exceeding testing standards.