Masks Dimensions: 175mm x 95mm
Racer mask line, ASTM F2100 LEVEL 2 SURGICAL GRADE FACE MASK.
Racer Technology is a HSA Licensed Manufacturer, US FDA Establishment Registration.
In Racer , we believe Quality is a must to ensure its manufacturing capabilities
- a. Product Certification
- b. Product Certification Compliance
- c. Process Validation (IQ/OQ/PQ)
- Compliance with: ASTM F2100 Level 2 EN 14683 Type llR ASTM F1862 -07
Certified with:
- ISO 13485:2016 by SGS UK (Certificate No. SG08/01956)
- ISO 9001:2015 by TUV-SUD-PSB (Certificate No. 2004-1-0690)
- SO 14001:2015 by TUV-SUD-PSB (Certificate No. 2006-0347)
- US FDA Establishment Registration 9710609
- HSA (Health Sciences Authority) Licensed Manufacturer ES0001536
ASTM F2100 LEVEL 2: 3-PLY SURGICAL GRADE FACE MASK-> HSA Licensed Manufacturer Specifications:-- >98% BFE- Ear Loop Design- 3- PLY Disposable Surgical Face Mask- Without Glass Fibers- Hypoallergenic- Very Low resistance to breathing- Nose Bar Adaptable- High Filtration Capacity- Perfect Fitting-
ISO 10993-4, 10:2002- ISO 10993-5: 1999Certified with:--ISO 13485:2016 by SGS UK (Certificate No. SG08/01956)-ISO 9001:2015 by TUV-SUD-PSB (Certificate No. 2004-1-0690)-ISO 14001:2015 by TUV-SUD-PSB (Certificate No. 2006-0347)-US FDA Establishment Registration 9710609 Credibility: - - US FDA Establishment Registration 9710609-ISO 13485:2016 by SGS UK (Certificate No. SG08/01956)-ISO 9001:2015 by TUV-SUD-PSB (Certificate No. 2004-1-0690)-ISO 14001:2015 by TUV-SUD-PSB (Certificate No. 2006-0347)