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About this Mask:
510k cleared: Achieved market clearance to legally distribute to the USA. 510(k) number: K210705
4-Ply Construction: The outer and inner layers are made of Spunbond Polypropylene to provide high breathability and comfort. The material is biocompatibile (tested against ISO 10993:5,10) and is ideal for sensitive users. The Filter Layer is a proprietary combination of spunbond and meltblown filters that can provide over 98% efficiency in PFE and BFE.
Premium Tie Backs: The tie backs are made of polypropylene and free from natural rubber Latex. With its soft finish and strong tensile strength, it provides unmatched comfort anda more custom fit for long periods of use.
Strong Malleable Nose Wire: To conform to various types of face structures, the nose wire is made of iron wrapped in polypropylene to adjust to almost all face shapes and sizes.
Development and Manufacturing Process
The Defender Safety Procedure and Surgical Mask Line were designed and tested in the USA. The development was compliant under FDA QSR 820 Design Control, and the testing was performed in an accredited ISO 17025 testing facility. Manufacturing took place in China. The Manufacturing Facility is compliant with cGMP, and ISO 13485:2016.
The Defender Safety Medical Mask Product Line
Procedure Mask Level 1
- PFE ≥95%
- BFE ≥95%
- Penetration by synthetic blood: 80 mm Hg
- Delta Pressure< 5.0mm H₂0
- Flame Spread: Class 1
- ear loop
Procedure Mask Level 3
- PFE ≥98%
- BFE ≥98%
- Penetration by synthetic blood: 120 mm Hg
- Delta Pressure< 5.0mm H₂0
- Flame Spread: Class 1
- ear loop
Procedure Mask Level 3
- PFE ≥98%
- BFE ≥98%
- Penetration by synthetic blood: 160 mm Hg
- Delta Pressure< 6.0mm H₂0
- Flame Spread: Class 1
- ear loop
Loretta Jones
Reviewed in the United States on February 26, 2023
I am going to love this mask, because the mask behind the ear has one of my ears hurting and irritated. I am finishing up the other masks first before using them. Please stay tuned for results.
Midwest Customer
Reviewed in the United States on April 15, 2022
The masks seem well made. The size is barely adequate for someone with a large head, however. They have a slight plastic-y smell.
TinaB
Reviewed in the United States on September 21, 2021
The adjustible straps always allow the right fit for my face. I can also untie the top strap and keep the mask in place when getting in or out of the car.
Wanda Peraza
Reviewed in the United States on September 10, 2021
I liked that is easy to use and is very confort. What I dislike is that previously I received the mask with elastic bands and the last time I received them with straps wich I don't like it. Apparently the ones with elastic bands were unavailable at the moment and I didn't noticed they were offering the ones with strap, obviously was my fault.
Klaatu82
Reviewed in the United States on December 16, 2021
I am In the medical field and need to wear a mask for 9 hours a day. This brand has been the most comfortable with the highest level of protection possible. I mean… it sucks that we all have to wear masks… but as far as when I am at work, this is the best.
HammerTime
Reviewed in the United States on December 8, 2020
In order to visit my father-in-law in an assisted living facility, we were required to wear a Level 3 face mask, along with disposable gloves and eye protection. At a time when these masks were difficult to find, I was happy to find the Defender Safety- ASTM Level 3 Face Mask. It has ties and i would prefer ear loops, but easy to adjust for the right fit.
Anne G. Risa, DVM
Reviewed in the United States on December 19, 2020
Breathable, soft, and thick, with Chinese certificate of tested effectiveness. These masks make me feel safe, and I've bought them a second time. However, the inner surface becomes "fuzzy" after several hours of wear giving that "hair-in-the-nose" feeling, so not really good for repeated use. Nose wire is a little flimsy.
Robin Friedman
Reviewed in the United States on November 19, 2020
I ordered this mask because it tied behind the head. The ties are so rough that they made the skin on my face raw and irritated after just a few minutes. After a few days, my skin was so irritated I couldn’t use these masks anymore. The mask itself was fine, but the strings coming out of the mask were NOT comfortable like the ones I have worn in a hospital.
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