A&Z MED Surgical Mask

• Spunbond / Meltblown / Spunbond Layered (30+25+20 =75gsm)
• Laboratory Approved Mask (Ekoteks) of All Surgical Mask Tests
• Provides 98.8% Filtration to Type IIR Mask Standards
• FDA Certified
• CE Universal Certification Approved
• Fully Ultrasonic
• Untouched HYGIENIC Production
• Fully Compatible Nose Wire
• Protection and Comfort Together With Soft Elastic Ears.
• 3 Layers High Protective Layer
• Does not cause allergies
• Does not contain latex
• Paraben Free
• Does not contain nylon
• Intact Box Structure You Can Pull Out One By One
• 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 Respiratory protective devices - Filtered half masks for protection against particles - Features, 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. TS EN 14683 + AC Medical face masks - Requirements and test methods-Type IIR - Medical face masks - Requirements and test methods-Type IIR
7. ISO 13485: 2016 Quality Management System for Medical Devices / Quality Management System for Medical Devices
8. ISO 9001: 2015 Quality Management System / Quality Management System
9. FDA Certification