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Dastex Group GmbHDastex Group GmbH

Isofield® Volta

Nitrile glove

To this glove in our product portfolio

Facts


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Surface cleanliness
Grip
Elongation
Endotoxin pollution
Ion-free
Cytostatics compatible
Chemical protection
sterile
textured
hand specific

Nitrile

Isofield Volta, Art.-No. 37828

Material: Nitrile

Properties

  • 100% nitrile
  • disposable protective glove 
  • free from vulcanisation accelerators
  • cleaned of production residues with deionised water
  • low endotoxin load
  • gamma irradiated, min. 25 kGy
  • hand specific
  • colour neon green
  • textured glove palm and finger inside
  • cuffs with beaded edge

Advantages

  • protective glove against hazardous chemicals (protection type B) for three different classes of substances such as inorganic bases, peroxides, aldehydes: K Sodium hydroxide 40%; P Hydrogen peroxide 30%; T Formaldehyde 37%
  • protective glove against micro-organisms such as viruses
  • Acceptable Quality Limit of the highest performance level 3 (1 up to 3)
  • meets the requirements and physical properties for medical gloves for single-use (EN 455-2:2015)
  • low extractable and leachable ionic loads
  • manufactured in an ISO cleanroom of cleanliness class 5 and certified by the National Environmental Balancing Bureau (NEBB)
  • triple packed to avoid cross contamination

Application

  • microbiologically and particulate controlled cleanrooms
  • laboratories working with certain hazardous chemicals and/or microorganisms
  • sterile production environments
  • aseptic packaging areas
  • suitable as an under-glove for the double gloving procedure

Product recommen­dation based on cleanroom classes

Air cleanliness class EN ISO 14644-1
particulate monitored areas

123456789low dust

Hygiene zones according to GMP
microbiological monitored areas

ABCDE

PPE

Personal protective equipment
Regulation (EU) 2016/425

Cat. ICat. IICat. IIInot aplicable

A one-to-one classification of cleanroom gloves to a cleanroom class according to ISO 14644-1 is not possible. Recommendations can only be made based on cleanroom specific requirements, e.g. "abrasion resistance" or "particle emission". In the VDI guideline 2083 Part 9.2 the user can find additional information.

Technical data

    Unit of measurementValueTest method
Material
     100% Nitrile  
Perforation-free1
AQL value as defined in ISO 2859-1
for attribute testing on samples 		  AQL1 0.65
Level 3
Inspection level G1 		EN ISO 374-2:2019
Tear resistance before ageing
after accelerated ageing 		N min./typical 6.0/n. s.
n. s./n. s. 		EN 455-2:2015
Extreme elongation before ageing
after accelerated ageing 		% min.
 n. s.
n. s. 		EN 455-2:2015
Dimensions
nominal single wall thickness 		middle finger
glove palm
cuff 		mm
± 0.02 mm		 0.16
0.14
0.09 		EN 455-2:2015
Length   mm min./typical 290/300 EN ISO 21420:2020
Size/palm width
nominal (+/- 5 mm) 		6
6½
7
7½
8
8½
9
10 		mm
+/- 0.02 mm		 n. s. EN ISO 21420:2020
EN 455-2:2015
Permeation performance against chemicals     Type B EN ISO 374-1:2016 + A1:2018
Protection against microbiological pathogens
viruses or bacteria or fungi		     passed
viruses 		EN ISO 374-5:2016
Extractable particles ≥ 0.5 µm nominal
number/cm2		 1,800 IEST-RP-CC005.4
Extractable substances
Ions

Ammonium (NH4+)
Bromide (Br-)
Calcium (Ca+)
Chloride (ClO2-)
Copper (Cu+)
Fluoride (F-)
Iron (Fe+)
Lithium (Li+)
Magnesium (Mg+)
Nitrate (NO3-)
Nitrite (NO2-)
Phosphate (PO43-)
Potassium (K+)
Sodium (Na+)
Sulphate (SO42-)
Zinc (Zn+) 		µm/cm2
Spezifikation
n. s.
n. s.
n. s.
n. s.
n. s.
n. s.
n. s.
n. s.
n. s.
n. s.
n. s.
n. s.
n. s.
n. s.
n. s.
n. s. 		µm/cm2
Typical value
0.014
n. d.
0.522
0.110
n. d.
n. d.
n. s.
n. s.
n. d.
0.318
n. d.
n. d.
0.034
0.006
0.021
n. s. 		IEST-RP-CC005.4
Endotoxins
detected by LAL-test, kinetic turbidimetric
   Endotoxin units
(EU) per pair 		< 20 EU EN 455-3:2015
Silicones, amides, Di-n-octyl phthalate (DNOP)     n. s. IEST-RP-CC005.4
FTIR test procedure
Powder residue values   mg/gloves
typical (max. 2 mg) 		powder-free
< 2 mg 		ASTM D6124
Biocompatibility     n. s. ISO 10993-10:2010
Skin sensitization     passed ISO 10993-10:2021
Gamma irradiated
Sterility assurance level (SAL) 		    10-6 according EN ISO 11137-1:2015
Non volatile residues (NVR)   mg/g n. s. IEST-RP-CC005.4
ESD properties
surface resistance
contact resistance
charge decay
electrostatic properties (design + material requirements)		     n. s.

EN 1149-1:2006
EN 1149-2:1997
EN 1149-3:2004
EN 1149-5
Permeation resistance
of medical gloves for
chemotherapeutics 		    not applicable ASTM D6978-05(2019)
Shelf life from date of manufacture     three (3) years when stored properly
PU     20 pairs
packed in pairs in a folded PE sheet (Left/Right) and
sealed PE bag,
in a PE outer bag, lined carton		  
Carton quantity     200 pairs
20 PE outer bags
of 10 pairs		  
      n. s. = not specified
n. d. = not detected		  

The manufacturer's technical data listed above are typical values at the time of publication. They are not specifications. All data are without guarantee, changes are possible without prior notice.

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