Materials: |
Nonwoven fabric: Spunbond-Meltblown-Spunbond (SMS or SMMS fabric). |
|
- Neck fastener and reinforcements: cellulose polyester. |
|
- Cuff: polyester or jersey. |
Description: |
Design: orthopaedic type. |
|
- Wraparound: back closure with back panel flap (covering), braided side fastener, reinforced chest area and adjustable neckline. |
|
- Long raglan sleeves with reinforcements at forearms for medium OP with medium water flow. |
|
- Cuff: non-deforming, minimum length 12cm |
|
- Impervious, breathable. |
|
- Oval neck. |
|
- Colour: green or blue. |
Sizes: |
Size S: |
length 110cm |
|
Size M: |
length 120cm |
|
Size L: |
length 130cm |
|
Size XL: |
length 150cm |
|
Size XXL: |
length 160-170cm |
Unit presentation: |
1 gown, sterile, aseptic folding, double packaged, single-use. |
|
Sterile gowns must be supplied with double packaging: the interior layer in a sterile peel pack. |
Packaging and labelling: |
Unit presentation primary packaging: Product’s name, size and reference number; "sterile" with sterilization method; lot number, expiry date by year and month; "for single use"; and CE mark and reference number of notifying body. Must be multilingual: English, French and Spanish, others when available. |
Secondary packaging: |
Protected unit, labelling is the same as unit presentation. |
|
Additional required information: Number of units per secondary packaging. Information for product-specific storage conditions (e.g., temperature, pressure, light, humidity, etc.). |
Outer packaging: |
Packaging unit: strong carton. |
Other requirements: |
Meets EN Standard 13795 1-2-3 |
|
- EN 13795-1:2002: Surgical drapes, gowns and clean air suits, used as medical devices, for patients, clinical staff and equipment. General requirements for manufacturers, processors and products |
|
- EN 13795-2:2004: Surgical drapes, gowns and clean air suits, used as medical devices for patients, clinical staff and equipment. Test methods |
|
- EN 13795-3:2006: Surgical drapes, gowns and clean air suits, used as medical devices for patients, clinical staff and equipment. Performance requirements and performance levels |