A&Z MED FFP2 NR Filtering half mask

• Complies with FFP2 NR Mask Standards
• Each Mask Is Individually Packaged
• Laboratory Approved Mask (Universal) Of All Surgical Mask Tests
• FDA Certified
• Universal CE Certified
• Fully Ultrasonic
• Untouched HYGIENIC Production
• Fully Compatible Nose Wire
• Tires That Do Not Disturb The Ear
• Does not cause allergies
• Does not contain latex
• Paraben Free
• Does not contain nylon
• Comfortable Use for Hours with Cottony Soft Layers

Directives and Regulations
1. (EU) 2016/425 Personal Protective Equipment Directive / Personal Protective Equipment Directive
2. 2001/95 / EC (GPSD) Product Safety Directive / Product Safety Directive
3. Harmonized Standards / Harmonized Standards
4. TS EN 149: 2001 + A1: 2009 Respiratory protective devices - Filtered half masks for protection against particles - Properties, experiments and marking / Respiratory protective devices - Half masks with filters for protection against particles - Properties, experiments and marking
5. 93/42 / EC- Medical Device Directive / CLASS I (Non-sterile) Medical Devices Regulation / CLASS I (Non Sterile)
6. ISO 13485: 2016 Quality Management System for Medical Devices / Quality Management System for Medical Devices
7. ISO 9001: 2015 Quality Management System / Quality Management System