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 XTREME™ Sterile ORANGE NITRILE™ 300 DI, Art.-No. 3828-1
Material: Nitrile-polychloroprene mixture
Properties
- nitrile / polychloroprene mixture
- sterile
- packed in pairs in foil
- hand specific
Advantages
- good 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/ Polychloroprene | |||
|
Perforation-free1 AQL value as defined in ISO 2859-1 for attribute testing on samples | AQL1 | 0.65 Level 3 | ISO 374-2:2019 | |
| Tear resistance |
before ageing after accelerated ageing | N min./typical |
6.0/12.0 6.0/11.0 |
EN 455-2:2015 + ASTM D412-15a ASTM D573-04(2015) |
| Extreme elongation |
before ageing after accelerated ageing |
% min. |
≥ 500 ≥ 400 |
EN 455-2:2015 + ASTM D412-15a ASTM D573-04(2015) |
|
Dimensions nominal single wall thickness |
middle finger hand surface cuff | mm |
0.15 0.14 0.09 | ASTM D3767-03(2014) |
| Length | mm min./typical | 300/305 | EN ISO 21420:2020 | |
|
Size/palm width nominal (+/- 5 mm) |
5½ 6 6½ 7 7½ 8 8½ 9 10 | mm | n.s. |
EN ISO 21420:2020 EN 455-2:2015 |
| Extractable particles | ≥ 0.5 µm |
nominal number/cm2 | < 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+) |
µm/cm2 specification 0.050 0.030 0.500 0.400 n.s. 0.010 n.s. n.s. 0.010 0.200 0.050 0.050 0.050 0.050 0.050 n.s. |
µm/cm2 typical value 0.015 < 0.008 0.300 0.100 n.s. < 0.008 n.s. n.s. < 0.0008 0.090 < 0.008 < 0.008 0.020 0.008 0.008 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-octyl phthalate (DNOP) | not detectable |
IEST-RP-CC005.4 FTIR test procedure | ||
| Powder residue values |
mg/gloves typical (max.) |
powder-free ≤ 1.0 (max. 2.0) | ISO 21171:2006 | |
| Biocompatibility | certified |
ISO 10993-10:2010 | ||
| Powder residue values |
mg/gloves typical (max.) |
powder-free ≤ 1.0 (max. 2.0) | ISO 21171:2006 | |
| Chemical allergens | not detectable |
HPLC test method for qualitative analysis + aqueous phosphate solution extraction | ||
|
Gamma sterilized Sterility assurance level (SAL) |
10-6|
|
according to ANSI/AAMI/ | EN ISO 11137:2015 | |
| Non volatile residues (NVR) | mg/g | max. 30 | 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 | ||
|
Permeation resistance of medical gloves for chemotherapeutics | tested | ASTM D6978-05(2019) | ||
| PU |
20 pairs packed in pairs in PE bag and sealed PE bag, in PE outer bag | |||
| Carton quantity |
200 pairs 10 PE bags of 20 pairs |