Lakeland factory rushing to beat Omicron surge, producing 2 million masks a day
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This Respirator has been approved as a NIOSH N95 filtering facepiece Respirator, for use in Healthcare Settings, as a Surgical N95 Respirator conforming to recognized standards for Biocompatibility, Flammability, and Fluid Resistance.
Before occupational use of this Respirator, a written respiratory protection program must be implemented meeting all the local government requirements. In the United States, employers must comply with OSHA 29 CFR 1910.134 which includes medical evaluation, training, and fit testing.
ISO 9001:2015
ISO 13485:2016
ISO 22716:2007
cGMP Compliant
USFDA Quality System Regulation (QSR)
NIOSH Registered Facility
FDA Registered Facility
Certified Cleanrooms
NIOSH 42 CFR 84