FRSM Fluid Resistant Surgical Mask
EN14683:2019 Type IIR
(Box of 50)

Description

This is a box of 50 x Gesalife FRSM EN14683:2019 Type IIR Fluid resistant disposable surgical face masks, which also complies with the US FDA ASTM F2100-19.

Gesalife is a long established Premium German brand, that has been manufacturing medical protective equipment since the 1990’s. This is their 3 ply mask in blue, it is light weight and has excellent water repellency and air permeability.

They are manufactured in an ISO9001 and ISO13485 medical production facility, to EN14683:2019 Type IIR Fluid Resistant Surgical Mask (FRSM) European standards and ASTM F2100-19 US FDA standard, and have been validated for use by NHS Wales.

Features include:

• Sonic sealing and proper placement of folds

• Cool and breathable

• Lint free (3 Ply Non Woven)

• Hypoallergenic and Latex Free

• Ear loops

We have started to create a face mask FAQ’s page to help answer any questions you may have.

Also see our Standard Type II Face Masks and KN95 / FFP2. Plus we have available the highest specification N99 / FFP3 Face masks.

If you require a large quantity of Gesalife face masks (Volume Discounts available) or global delivery of these fluid resistant surgical masks please contact us.  

These masks cannot be returned due to the hygienic nature of them.

Conforms to:

• European EN14683:2019 Type IIR Fluid Resistant Surgical Face Mask (FRSM)
• EU Directive 93/42/EEC on Medical Devices (MDD), Annex V (TUV Certified)
• US FDA ASTM F2100-19
• ISO 13485:2016 Medical Devices Quality Management Production Facility
• ISO 9001:2015 Factory Quality Management System
• ISO 10993 Biocompatibility

Tests Include:

• Bacterial Filtration Efficiency (BFE) to EN14683:2019 Annex B and ASTM F2101-19.  (Required > 98% Actual >99%)
• Differential Pressure (Delta P) to EN14683:2019 Annex C and ASTM F2100-19. (Required <60 Pa/cm2 Actual Avg. 53.08 Pa/cm2)
• Synthetic Blood Penetration Resistance to ASTM F1862 and ISO 22609 (As required by EN14683:2019 and ASTM F2100-19). (Required >16 kPa Actual Pass)
• Microbial Cleanliness (Bioburden)  to EN14683:2019. (Required <30 cfu/g Actual <1.6 cfu/g)

All Certifications can be provided on request and verifiable direct with TUV

CE and FDA Approval (Registration 3009751960).