Defender Safety- ASTM Level 3, 4 Layer, …
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Product Description
Top of the line masks for everyone
The Defender Safety Level 3 Procedure Mask is a 510(k) cleared Procedure Mask. It is intended to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids and particulate material. Made with high quality Polypropylene and Spandex; The Level 3 Masks are comfortable to wear and free from natural rubber latex. The Mask consists of a metal wire wrapped in polypropylene to provide a better fit around the user’s face. The proprietary melt blown and spunbonded layers consist of an electrostatic charge that deflects incoming particles and allows for both higher protection and improved breathability. It is the perfect combination of performance and comfort.
About this Mask:
510(k) 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 filter that can provide over 98% efficiency in PFE and BFE.
Premium Ear Loops: Ear loops are made of Spandex and free from natural rubber Latex. With its soft finish and strong tensile strength, it provides unmatched comfort and 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.
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Customer Reviews
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Particle Filtration Efficiency (PFE):
≥95% ≥98% ≥98% ≥98%
Bacterial Filtration Efficiency (BFE):
≥95% ≥98% ≥98% ≥98%
Penetration by synthetic blood:
80 mmHg 120 mmHg 160 mmHg 160 mmHg
Flame spread class:
Class 1 Class 1 Class 1 Class 1
Delta Pressure:
< 5.00mm H2O < 6.00mm H2O < 6.00mm H2O < 6.00mm H2O
Type:
ear-loop ear-loop ear-loop tie-back
Product Dimensions : 7.5 x 3.5 x 3.5 inches; 8.53 ounces
Department : Unisex Adult
Date First Available : July 29, 2020
ASIN : B08DJ45ZRF
Customers say
Customers find the safety masks comfortable and well-constructed. They appreciate the thick, high-quality material that provides good protection and breathability. However, some customers have reported issues with the ear straps breaking easily. Opinions vary on the fit and value for money.
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