3PLY FDA 510(k) Approval - K211249

3PLY FDA 510(k) Approval - K211249

The Altor Surgical 3Ply Face Masks is now fully approved by a 510(k) as a Medical Device.  The Altor Safety 3-Ply Surgical Mask (Model:62222) is intended to be worn to protect both the patient and healthcare professional from transfer of microorganisms, body fluids, and particulate material. The Altor Safety 3-Ply Surgical Mask is intended for use in infection control practices to reduce the potential exposure to blood and body fluids. This is a single use, non-sterile, disposable device.

When compared to other products it is either equal or outperforms other masks, some stats are as follows:

Fluid Resistance Performance (ASTM F1862-13) Passed 32 out of 32 Samples at 120mmHG

Particulate Filtration Efficiency (ASTM F2299) Greater than 99%

Bacterial Filtration Efficiency (ASTM F2101) Ranging from 99.60% to 99.80%

Differential Pressure (DeltaP) EN 14683 2.6mmH 2 o/cm 2

Flammability (16 CFR 1610) Class 1

Cytootxicity - Passed all studies for skin sensitivity and irritation 

Please feel free to reach out to our team for a copy of any of the FDA reports or testing reports of the masks - we are always happy to share them with you! 


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