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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