ASTM Level 1 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 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