ASTM Level 1 Mask - Procedure Face Mask, FDA 510(k) Cleared, Medical Grade
Defender Safety Level Procedural Mask are FDA 510(k)cleared. It is intended to protect both the patient and healthcare personnel from the transfer of microorganisms, body fluids and particulate material.
- Medical grade: FDA 510(k) cleared (K210705)
- Design: Ear loop configuration, pleated mask adjustable nose bridge, blue, not made from natural rubber latex.
- Performance: ASTM F2100-19
- Dimension: 175mm wide, 95mm long
Description
BUILT FROM THE GROUND UP AND FDA 510(K) CLEARED
We designed with the best materials and melt-blown to create a medical mask that you can rely on. Achieved market clearance to legally distribute to the USA. 510(k) number: K210705
THIRD PARTY TESTED
Tested to ASTM F2100-19 Level 1 Standards by an ISO 17025 accredited testing lab facility to ensure accurate results. The PM01 has the performance of BFE> 95%, PFE> 95%, Liquid Barrier: 80 mmHg
3-PLY CONSTRUCTION
The outer and inner layers are made of spun-bonded polypropylene to provide high breathability and comfort. The material is biocompatible (tested against ISO 10993:5,10) and is ideal for sensitive users. The filter layer is made of a proprietary melt-blown filter that can provide over 95% 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 prolonged periods of use.
STRONG MALLEABLE NOSE WIRE
To conform to diverse types of face structures, the nose wire is made of iron wrapped in polypropylene to adjust to different face shapes and sizes.
PROTECTION YOU CAN RELY ON
The Defender Safety Procedural ASTM Level 1 mask is an FDA-cleared mask. It is intended to protect both the patient and healthcare personnel from the transfer of microorganisms, body fluids, and particulate material. Made with high-quality polypropylene and spandex; these ASTM Level 1 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 spun-bonded 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.
Trusted by the pros.
Our masks are FDA 510k cleared and trusted by thousands of healthcare professionals.
PROTECTION YOU CAN RELY ON
The Defender Safety Procedural mask are FDA-cleared mask. It is intended to protect both the patient and healthcare personnel from the transfer of microorganisms, body fluids, and particulate material. Made with high-quality polypropylene and spandex; these 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 spun-bonded 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.
Product specifications
Compare Defender Safety's Medical Masks
Level 1, 510k Cleared
Level 2, 510k Cleared (MADE IN USA)
Level 3, 510k Cleared
95%
98%
98%
80 mmHg
12 mmHg
160 mmHg
Ear loop
Ear loop
Ear Loop
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