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Dastex Group GmbHDastex Group GmbH

KIMTECH™ G3 Sterile
Sterling™ Nitrile

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

Kimtech™ G3 Sterile Sterling™ Nitrile, Art.-No. 3524

Material: Nitrile

Properties

  • 100 % nitrile
  • latex-free, powder-free, silicone-free
  • beaded cuff
  • packed pairwise in peel-off bags to meet ISO Class 3 cleanroom standard
  • hand-specific

Advantages

  • excellent dexterity and tactile sensitivity (level 5)
  • low endotoxin content
  • CE-certified as PPE product Cat. III
  • electrostatic dissipative property in use
  • packaged for aseptic donning
  • multiple packages for putting under aseptic conditions

Application

  • for high process requirements (life science, pharmaceutical, aseptic areas)
  • for work with chemicals, including cytostatics

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 generation". 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 1.5 ASTM D5151 + EN 374-2
Tear resistance before ageing
after accelerated ageing 		MPa, nominal 42
38 		ASTM D412 + ASTM D573
Extreme elongation before ageing
after accelerated ageing 		%, nominal
 650
550 		ASTM D412 + ASTM D573
Dimensions
nominal single wall thickness		 middle finger
palm of hand
cuff 		mm 0.10
0.08
0.07 		ASTM D6319 + EN 455-2
Length   mm
" 		305
12 		 
Size/palm width
nominal 		6
6½
7
7½
8
8½
9
10 		mm 80
87
94
98
109
114
120
128 		ASTM D6319 + EN 455-2
Biocompatibility     n.s. Primary Skin Irritation Tests +
Dermal Sensitization Test
according to ASTM F720-13
Dexterity   class 5 EN ISO 21420:2020
Extractable particles > 0.5 µm number/cm2 1,500 IEST-RP-CC005
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
specification
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
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. 		IEST-RP-CC005.4
Non volatile residues (NVR)   mg/g n.s. IEST-RP-CC005.4
Endotoxins (maximum) Endotoxin units (EU) per pair 20 Kinetic turbidimetric
LAL test method
DC resistance   Ω2 n.s. ASTM D257-14
Permeation resistance of medical
gloves for chemotherapeutics 		    compliant
no breakthrough up to 240 min
(except Carmustine 3.3 mg/ml: 20.4 min/
Thiotepa 10.0 mg/ml: 110 min)		 ASTM D6978-05
PU     250 pieces
flat double bagged		  
Packing unit     30 pairs
pairwise in a peel-off pouch,
per bag		  
Cardboard quantity     300 pairs
10 x 30 pairs/bag
packed in a big bag		  

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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