Facts
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Surface cleanliness
Grip
Elongation
Endotoxin pollution
Ion-free
Cytostatics compatible
Chemical protection
sterile
textured
hand specific
Nitrile-polychloroprene mixture
SHIELDskin™ ORANGE NITRILE™ 300 Sterile, Art.-No. 3828
Material: Nitrile-polychloroprene mixture
Properties
- nitrile / polychloroprene mixture
- sterile
- packed in pairs in foil
- ambidextrous
Advantages
- adequate surface cleanliness
- very high elasticity
- high permeation time with disinfectants
- tested with cytostatics
- very high tear resistance
Application
- sterile production / aseptic filling
- for cleaning / disinfection with disinfectants and biocides
- for the production of cytostatics
- for heavy mechanical stress
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 | ||
| Material |
Nitrile (NBR)/ Polychloroprene (CR) | |||
|
Perforation-free1 AQL value as defined in ISO 2859-1 for attribute testing on samples | AQL1 | 0.25 Level 3 | ISO 374-2:2019 | |
| Tear resistance |
before ageing after accelerated ageing | N min/typical |
≥ 6.0/10.0 ≥ 6.0/8.0 |
EN 455-2:2015 ASTM D573-04(2019) ASTM D412-16 |
| Extreme elongation |
before ageing after accelerated ageing |
% min |
≥ 500 ≥ 400 |
EN 455-2:2015 ASTM D573-04(2019) ASTM D412-16 |
|
Dimensions nominal single wall thickness |
middle finger palm cuff | mm |
0.17 0.14 0.10 | ASTM D3767-03(2020) |
| Length | mm min/typical | ≥ 290 300 | EN 455-2:2015 | |
|
Size/palm width nominal (+/- 5 mm) |
XS / 6 S / 7 M / 8 L / 9 XL / 10 XXL / 11 | mm |
≤ 80 85 95 105 ≤110 | EN 455-2:2015 |
|
Size/Hand circumference nominal |
XS / 6 S / 7 M / 8 L / 9 XL / 10 XXL / 11 | mm |
152 178 203 229 254 | EN ISO 21420:2020 |
| Biocompatibility | passed |
ISO 10993-10:2010 Tests after irritation and skin sensitization | ||
| Extractable particles | > 0.5 µm |
fixed typical number/cm2 |
n.s. < 3,000 | 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+) |
µg/cm2 specific 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. |
µg/cm2 specific 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 |
|
Endotoxins detected by LAL test, kinetic turbidimetric |
Endotoxin units (EU) per pair | < 20 | EN 455-3:2015 | |
|
Silicones, amides, Di-n-octylphthalate (DNOP) | not detectable |
IEST-RP-CC005.4 FTIR test procedure | ||
|
Powder residues on the surface |
mg/glove typical | approx. 1.0 – max. 2.0 | ISO 21171:2006 | |
| Vulcanisation accelerators | free | reduces the risk of contact dermatitis (type IV allergy/chemical allergy) | ||
|
Gamma irradiated Sterility Acceptance Level (SAL) |
10-6|
ISO 11137:2015
| | ||
| Non volatile residues (NVR) | µg/g | n.s. | IEST-RP-CC005.4 | |
|
ESD properties surface resistance contact resistance charge decay electrostatic properties (design + material requirements) |
tested | EN 1149-1:2006 EN 1149-2:1997 EN 1149-3:2004 EN 1149-5:2018 | ||
|
Permeation resistance of medical gloves for chemotherapeutics | tested | ASTM D6978-05(2019) | ||
| PU |
20 PE peel off pouches with 1 pair each, in a sealed poly bag | |||
| Carton quantity |
160 pairs 8 sealed poly bags per PE outer bag |