NITRILE EXAMINATION GLOVES
Hellange® premium examination gloves have been specifically designed to meet all the needs of healthcare professionals. Sophisticated design features include ergonomic technologies that ensure comfort and ensure maximum sensitivity even during prolonged work.
Caregivers who are well prepared and comfortably protected with Hellange® gloves can focus with peace of mind on what really matters: the health and protection of themselves and their patients.
Product Specifications
| TYPE |
HELLANGE® Powder free examination and disposable protective glove, non sterile, 3,5g |
| MATERIAL | Nitrile butadiene rubber (NBR) |
| COLOUR | ocean blue |
| GLOVE SHAPE | flat with beaded cuff, ambidextrous |
| GLOVE SURFACE | finger textured |
| WEIGHT | 3.5g |
| SIZE | Small (S), Medium (M), Large (L), Extra Large (XL) |
| OVERALL LENGTH | median 240 mm (as per EN 455-2) |
| SINGLE WALL THICKNESS |
Finger: 0.10 mm (3.9 mil) Cuff: 0.06 mm Palm: 0.09 mm |
| BARRIER PERFORMANCE | AQL 1.5 (as per EN 455-1) |
| FORCE AT BREAK | median ≥ 6 Newton (as per EN 455-2) |
|
PACKAGING |
100 gloves per dispenser box 10 dispenser boxes per carton |
| DISPENSER BOX SIZE | 230 x 113 x 70mm |
| CARTON SIZE | 270 x 270 x 340mm |
| QUANTITY PER CONTAINER | 20’ Container: 1323 Cartons (1.323 Million Gloves) 40’ HC Container: 3360 Cartons (3.366 Million Gloves) |
| QUALITY STANDARDS & CERTIFICATES |
ISO 9001:2015, ISO 13485:2016,
EN 455-1:2000, EN 455-2:2015, EN 455-3:2015, EN 455-4:2009, EN ISO 21420, EN 420:2003-A1:2009, ISO 374-1:2016, EN 374-2:2014, EN 16523-1:2015, EN 374-4:2013, EN ISO 374-5:2016, Res AP (2004)4, ASTM D6319-19 |
| INTENDED PURPOSE |
Medical device class I as set out in MD Regulation (EU) 2017/745
Single-use protective glove – PPE category III (protection against chemical substances for limited time)* as set out in PPE Regulation (EU) 2016/425
Suitable for food contact (as per Regulation (EC) 1935/2004 on Food Contact Materials) |
| STORAGE | Keep storage area cool, dry and dust free. Protect gloves against ultraviolet light sources, sunlight and oxidizing agents. Store in original packaging in a dry and dark place at 10° to 30°C. |
| SHELF LIFE | 3 years from the date of manufacturing |
| ADDITIONAL INFORMATION | For declaration of conformity please visit: www.advipha.com/userinformation |
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