Lakeland factory rushing to beat Omicron surge, producing 2 million masks a day
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- Surgical N95 Respirator - TC-84A-9318
- Domestically Produced - Lakeland, Florida
- Approved & Cleared for Use in Healthcare Settings by FDA/NIOSH
Our N95 Story
- ASTM F1862 Level 3 Fluid Resistance – Highest Level of Protection (160 mm Hg)
- Flammability Class 1
- Provides protection against particulates at the N95 filter efficiency level
- Conforms to recognized standards for Flammability, Fluid Resistance, and Biocompatibility
- Strong straps ultrasonically bonded, not stapled to the mask
- Exceptional Breathability, Fit, Comfort, and Quality
- One of the Largest Domestic Manufacturers of N95s
- Flexible contour nosepiece
- Malleable strip allows for custom fit to virtually any face
- Secure and comfortable
- Ultrasonically-welded head straps for a one-size fits all
- High quality performance materials
- Non-abrasive comfort layer with excellent moisture management
- Filtration material layers provide pfe of ≥95% @ 0.3µ minimizes particle dispersal
- Blue outer cover deflects fluid without sacrificing breathability
- Designed for better breathability
- Pouched design provides cooler breathing chamber
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.
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CERTIFICATIONS & REGISTRATIONS
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