Facts
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Surface cleanliness
Grip
Elongation
Endotoxin pollution
Ion-free
Cytostatics compatible
Chemical protection
sterile
textured
hand specific
Latex
SHIELDskin XTREME™ Sterile Latex 300 DI, Art.-No. 3808
Material: Latex
Properties
- 100% latex
- sterile
- fingertips and palm structured
- rolled edge
- packed in pairs in foil
- hand specific
Advantages
- adequate surface cleanliness
- very good fit
- very high elasticity
- very high tear resistance
Application
- sterile production / aseptic filling
- 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 |
100% Latex (Natural Rubber) | |||
|
Perforation-free 1AQL 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 |
9.0/14.0 6.0/12.0 |
EN 455-2:2015 + ASTM D412-15a ASTM D573-04(2015) |
| Extreme elongation |
before ageing after accelerated ageing |
% min. |
700 500 |
EN 455-2:2015 + ASTM D412-15a ASTM D573-04(2015) |
|
Dimensions nominal single wall thickness |
middle finger palm cuff | mm |
0.20 0.18 0.12 | ASTM D3767-03(2014) |
| Length | mm min./typical | 290/300 | EN ISO 21420:2020 | |
|
Size/palm size nominal (+/- 5 mm) |
5.5 6 7 7.5 8 8.5 9 10 | mm | n.s. | EN ISO 21420:2020 |
|
Size/Hand circumference nominal |
5.5 6 7 7.5 8 8.5 9 10 |
mm |
140 152 165 178 191 203 216 229 | EN ISO 21420:2020 |
| Extractable particles | ≥ 0.5 µm/cm2 |
fixed typical |
3,000 1,100 | 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 measuring method | ||
| Non volatile residues (NVR) | µg/g | < 30 | 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 0.100 0.030 0.500 0.750 n.s. 0.010 n.s. n.s. 0.010 0.400 0.050 0.050 0.050 0.050 0.100 n.s. |
µg/cm2 typical 0.030 < 0.008 0.250 0.380 n.s. <0.008 n.s. n.s. < 0.008 0.150 < 0.008 < 0.008 0.020 0.011 0.015 n.s. | IEST-RP-CC005.4 |
| PU |
20 pairs pairwise packed in a PE peel pouch, per sealed poly bag | |||
| Carton quantity |
200 pairs 10 poly bags in a PE bag per double-walled carton |