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! 


  • Sheila Burroughs

    First I want to say I like your mask. They seem better then most of the ones I have tried. I can’t blow out a match with the 4-ply mask. Now to the problem. I purchased 2 boxes of the 4-ply 50 ct mask (Order # 301163) and the ear strap is breaking off mostly on the left corner of the mask when wearing it. 1 out of every three mask seem to break on me and others I have given them to who are women. We don’t have large faces, so not sure what’s causing them to break.
    1. Is it possible to replace the 2 boxes I order from a different batch?
    2. Is the 3-ply mask better for use will visiting doctor offices and hospitals than the 4-ply?
    thank you

  • mark mayer

    I found your product online and bought because it was made in the USA … and not ‘imported.’ I’m also finding out your company is relatively new. Is this correct? MOST IMPORTANTLY for us consumers, nowhere on the outside of the box and inside is any if about mode 62222 being FDA approved and the approval number. Why? I’d think you’d want to make this info very visible!

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