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Nitrile
Kimtech™ G3 Sterile Sterling™ Nitrile, Art.-No. 3524
Materiaal: 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
Productkeuze op basis van de cleanroomklassen
Luchtreinheidsklasse ISO 14644-1
op deeltjes gecontroleerde gebieden
Hygiënezones conform GMP
microbiologisch gecontroleerde gebieden
PBM
Persoonlijke beschermingsmiddelen
conform verordening (EU) 2016/425
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.
Technische gegevens
| Unit of measurement | Value | Test 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 |