Facts
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Surface cleanliness
Grip
Elongation
Endotoxin pollution
Ion-free
Cytostatics compatible
Chemical protection
sterile
textured
hand specific
Nitrile
Kimtech™ Purple Nitrile™, Art.-No. 3540
Material: Nitrile
Properties
- 100% nitrile
- powder-free
- packed in boxes
- ambidextrous
Advantages
- adequate surface cleanliness
- high permeation time for chemicals
- tested with cytostatics
Application
- for laboratory requirements
- for working with chemicals
- for production of cytostatics
Product recommendation based on cleanroom classes
Air cleanliness class EN ISO 14644-1
particulate monitored areas
Hygiene zones according to GMP
microbiological monitored areas
PPE
Personal protective equipment
Regulation (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 emission". In the VDI guideline 2083 Part 9.2 the user can find additional information.
Technical data
| Unit of measurement | Value | Test method | ||
|
Perforation-free1 AQL value as defined in ISO 2859-1 for attribute testing on samples | AQL1 | 0.65 | EN 374-2:2014 + ASTM D 5151 | |
| Material | 100% nitrile | |||
| Tear resistance |
before ageing after accelerated ageing |
MPa, nominal MPa, nominal |
21 21 | ASTM D412, ASTM D573 + ASTM D3578 |
| Extreme elongation |
before ageing after accelerated ageing |
%, nominal %, nominal |
550 500 | ASTM D412, ASTM D573 + ASTM D3578 |
|
Dimensions nominal single wall thickness |
middle finger palm cuff | mm |
0.16 0.14 0.11 |
ASTM D3767, ASTM D6319 + EN ISO 21420:2020 |
| Length |
XS - S - M L - XL |
mm |
240 250 | |
| Size/palm width |
XS S M L XL | mm |
70 80 95 110 120 |
ASTM D3767, ASTM D6319 + EN ISO 21420:2020 |
| Biocompatibility | n.s. |
Primary Skin Irritation Tests + Dermal Sensitization Test according to ASTM F720-13 | ||
| Extractable particles | > 0.5 µm | number/cm2 | n.s. | 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 | n.a. |
Kinetic turbidimetric LAL test method |
| Powder residue values |
mg/gloves typical (max.) |
powder-free ≤ 1.0 (max. 2.0) | ISO 21171:2006 | |
| FTIR spectrometer |
silicones, amides, Di-n-octylphthalate (DOP) | no values detectable | n.s. | |
|
Electrostatic behaviour | dissipative |
EN 1149-5:2003 | ||
|
Permeation resistance of medical gloves for chemotherapeutic agents |
compliant no breakthrough up to 240 min (except Carmustine 3.3 mg/ml: 10.4 min) | ASTM D6978-05 | ||
| PU |
XS - S - M - L XL |
100 pieces in carton dispenser box 90 pieces in carton dispenser box | ||
| Carton quantity |
XS - S - M - L XL |
1,000 pieces 900 pieces |