Defender Safety- ASTM Level 1 95% PFE, Medical Grade, Procedure Face Mask (50 Pack)

About this Mask:

FDA 510k approved: Achieved market clearance to legally distribute to the USA. 510(k) number: K210705

3-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 made of a proprietary meltblown 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 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.