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Approved Suppliers
Health Service Executive Ireland
ISOL8 Healthcare Ltd is EN ISO 13485 certified
Our Elemental gown provides an affordable solution for procedures where low to moderate levels of fluid are expected. Constructed from 48gsm SMMS fabric, it provides high level barrier properties while also offering a high level of breathability to ensure optimal comfort for the wearer.
The ergonomic fit with raglan sleeves provides the wearer with added comfort, a greater range of movement and allows for easier donning.
| Product Name | Elemental Standard Surgical Gown |
| Manufacturer Product Codes (MPN) | IS8E01 (M), IS8E02 (L), IS8E03 (XL), IS8E04 (XL-Long), IS8E05 (2XL), IS8E06 (2XL-Long), IS8E07 (3XL) |
| Manufacturer | ISOL8 Healthcare Ltd. |
| Gown type | Standard sterile surgical gown – Single use only |
| Compliance with standard | EN13795 – Standard Performance |
| Sizes | M, L, XL, XL-Long, 2XL, 2XL-Long, 3XL |
| Fabric | SMMS 48gsm (100% polypropylene) |
| Gown cut | Raglan sleeves for better unrestricted movement and easier donning |
| Sleeve seam | Ultrasonic welded |
| Neck closure | Hook and loop |
| Cuffs | Soft knitted cuffs |
| Anti-static | Yes |
| Colour | Blue |
| Sterility | Sterile |
| Pack contents | 2 x sterile scrim towels – 50×40 cm 1 x SMS sterile wrap – 60×60 cm |
| Ties | Double bonded ultrasonic welded SMS ties, Inner ties: 40±2 cm (both), Outer ties: 75±5 cm and 40±5 cm |
| Latex status | Not made with natural rubber latex |
| Metal status | Nickel and cadmium free |
| Shelf-life | 3 years |
| CE certification | MDD 93/42/EEC – Class Is medical device Notified body ICIM (CE 0425) |
| Manufacturer QMS | ISO 13485 |
| Product packaging (inner pack) | Gown pack (sterile pouch) 340x230x50±20 mm |
| Product packaging (outer carton) | 40 gown packs per carton 600x390x350 mm |
| Recycling Information | Outer carton is 100% recyclable (cardboard) Inner pack and product are non-recyclable |
| Order code | Product | Quantity |
|---|---|---|
| IS8E01 | Elemental Gown Standard M | 40 |
| IS8E02 | Elemental Gown Standard L | 40 |
| IS8E03 | Elemental Gown Standard XL | 40 |
| IS8E04 | Elemental Gown Standard XL-Long | 40 |
| IS8E05 | Elemental Gown Standard 2XL | 40 |
| IS8E06 | Elemental Gown Standard 2XL-Long | 40 |
| IS8E07 | Elemental Gown Standard 3XL | 40 |
| Size | Length (cm) | Hem circumference (cm) |
| M | 115 | 145 |
| L | 127 | 150 |
| XL | 135 | 155 |
| XL-Long | 150 | 155 |
| 2XL | 145 | 160 |
| 2XL-Long | 160 | 160 |
| 3XL | 150 | 165 |
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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
