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Dastex Group GmbHDastex Group GmbH

KIMTECH™ G3 Sterile White 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 White Nitrile, Art.-No. 3529

Material: Nitrile

Properties

  • 100% nitrile
  • validated sterile (SAL 10-6)
  • textured fingertips 
  • smooth – double gloving suitable
  • foil-wrapped in pairs
  • hand specific

Advantages

  • good surface cleanliness
  • high mechanical resilience
  • high abrasion resistance
  • tested with cytostatics

Application

  • sterile production / aseptic packaging
  • for production of cytostatics
  • for heavy mechanical stress

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 1.5 ASTM D5151 + EN 374-2
Tear resistance before ageing
after accelerated ageing 		MPa, nominal 24
26 		ASTM D412 + ASTM D573
Extreme elongation before ageing
after accelerated ageing 		%, nominal
 600
550 		ASTM D412 + ASTM D573
Dimensions
nominal single wall thickness		 middle finger
palm of hand
cuff 		mm 0.16
0.13
0.10 		ASTM D6319 + EN 455-2:2015
Length   mm
" 		305
12 		 
Size/palm width 6
6½
7
7½
8
8½
9
10 		mm 80
87
94
98
109
114
120
128 		ASTM D6319 + EN 455-2:2015
Biocompatibility     n.s. Primary Skin Irritation Tests +
Dermal Sensitization Test
according to ASTM F720-13
Extractable particles > 0.5 µm number/cm2 950 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
Surface Resistance   Ω/sq. dissipative ASTM D257-14
Permeation resistance of medical
gloves for chemotherapeutics 		    compliant
no breakthrough up to 240 min
(except Carmustine 3.3 mg/ml: 10.4 min)		 ASTM D6978-05
PU     200 pairs
10 bags of 20 pairs,
pairwise in a peel-off pouch		  
Cardboard quantity     200 pairs  

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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