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Approved Suppliers
Health Service Executive Ireland
ISOL8 Healthcare Ltd is EN ISO 13485 certified
Our FLUIDSAFE anti-fog procedure mask is manufactured from high quality fabric with a super soft silk-like inner material providing excellent comfort to the wearer. The anti-fog foam strip prevents fogging and the adjustable face visor provides enhanced protection to the upper face against fluids and particulates. Our type IIR masks provide the highest barrier performance and their fluid resistant properties offer protection against splashing during procedures.
Our procedure masks are most suited for use in clinical environments for patient encounters, examinations and minor procedures. Elastic earloops are easy to apply and provide a comfortable fit.
| Manufacturer Product Codes (MPN) | IS8RM03P |
| Manufacturer | ISOL8 Healthcare Ltd. |
| Mask type | Fluid resistant anti-fog procedure mask with face visor. Suitable for use with spectacles and eyewear. |
| Compliance with standard | EN14683:2019 Type IIR |
| Mask size (Length x Width) | 175×95 mm |
| Mask fit | Earloops |
| Colour | Orange stripes with black UV strip (Other colours available on request) |
| Sterility | Non-sterile |
| Mask fabric (3-layers) | Outer: 35gsm Spunbond Polypropylene, Middle: 30gsm Meltblown Polypropylene Inner: 18gsm extra soft ES silk-like fibre |
| Earloops | Spandex polyurethane coated with nylon thread 160±5mm x 3mm |
| Nose bar material | Full length aluminium nose piece |
| Visor/Face Shield | Double-sided anti-fog treated PET (0.1mm thick) 295×125 mm |
| Anti-fog nose strip | Full length soft anti-fog foam strip |
| Black UV Strip | 40gsm Spunbond Polypropylene |
| Latex status | Not made with natural rubber latex |
| Metal status | Nickel and cadmium free |
| CE certification | MDR 2017/745 – Class I medical device |
| Manufacturer QMS | ISO 13485 |
| GTIN code inner box | 05391541270324 |
| GTIN code outer carton | 05391541270850 |
| Order code | Product | Quantity |
|---|---|---|
| IS8RM01P | FLUIDSAFE Procedure Mask | 40 boxes of 50 masks (2000 masks) |
| IS8RM01S | FLUIDSAFE Surgical Mask | 40 boxes of 50 masks (2000 masks) |
| IS8RM02P | FLUIDSAFE Anti-fog Procedure Mask | 40 boxes of 50 masks (2000 masks) |
| IS8RM02S | FLUIDSAFE Anti-fog Surgical Mask | 40 boxes of 50 masks (2000 masks) |
| IS8RM03P | FLUIDSAFE Procedure Mask with Visor | 8 boxes of 50 masks (400 masks) |
| IS8RM03S | FLUIDSAFE Surgical Mask with Visor | 8 boxes of 50 masks (400 masks) |
| IS8RM04P | FLUIDSAFE Child-friendly Procedure Mask | 40 boxes of 50 masks (2000 masks) |
| IS8RM04S | FLUIDSAFE Child-friendly Surgical Mask | 40 boxes of 50 masks (2000 masks) |
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ISOL8 Healthcare Ltd
Unit 4 Joyce House, Barrack Square,
Ballincollig, Co. Cork, P31 HW35
Ireland
Ireland: +353 (0) 667 121 659
