ASTM Level 3 Mask – Procedure Face Mask, FDA 510(k) Cleared, Medical Grade

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 3 Mask Standards by an ISO 17025 accredited testing lab facility to ensure accurate results. The PM01 has the performance of BFE> 98%, PFE> 98%, Liquid Barrier: 160 mmHg

4-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 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 distinct types of face structures, the nose wire is made of iron wrapped in polypropylene to adjust to different face shapes and sizes.

TOP OF THE LINE MASK FOR EVERYONE

The Defender Safety ASTM Level 3 Mask is an FDA-approved procedure 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.