ASTM Level 3 Pleated Face Mask with Tie-Back - 4-Ply Blue Disposable Medical Masks (30 Pack) - Ideal for Healthcare Workers, Construction Sites & Public Safety

Product Description

Top of the line masks for everyone The Defender Safety Level 3 Surgical Mask is a 510(k) approved Surgical Mask. It is intended to protect both the patient and healthcare personnel from body fluids and particulate material. Made with high quality Polypropylene and Spandex; The Level 3 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 meltblown and spunbond 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. About this Mask: 510k cleared: Achieved market clearance to legally distribute to the USA. 510(k) number: K210705 4-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 a proprietary combination of spunbond and meltblown filters that can provide over 98% efficiency in PFE and BFE. Premium Tie Backs: The tie backs are made of polypropylene and free from natural rubber Latex. With its soft finish and strong tensile strength, it provides unmatched comfort anda more custom 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. The Defender Safety Medical Mask Product Line Procedure Mask Level 1 PFE ≥95%BFE ≥95%Penetration by synthetic blood: 80 mm HgDelta Pressure< 5.0mm H₂0Flame Spread: Class 1ear loop Procedure Mask Level 3 PFE ≥98%BFE ≥98%Penetration by synthetic blood: 120 mm HgDelta Pressure< 5.0mm H₂0Flame Spread: Class 1ear loop Procedure Mask Level 3 PFE ≥98%BFE ≥98%Penetration by synthetic blood: 160 mm HgDelta Pressure< 6.0mm H₂0Flame Spread: Class 1ear loop