ASTM Level 2 Mask – Procedure FDA 510(k) Cleared Face Mask, Medical Grade

MADE IN USA

The ASTM Level 2 Mask is manufactured in the USA and achieved market clearance to legally distribute. 510(k) number: K202595

THIRD PARTY TESTED

Tested to ASTM F2100-19 Level 2 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: 120 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 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 extended 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.

USA MADE LEVEL 2 FACEMASK 

Defender Safety Level 2 Procedural Mask is an FDA-cleared mask. It was designed, developed, and manufactured in the USA and 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 2 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.