Facts
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Surface cleanliness
Grip
Elongation
Endotoxin pollution
Ion-free
Cytostatics compatible
Chemical protection
sterile
textured
hand specific
Neoprene/polychloroprene
BioClean™ Suprene BSNS, Art.-No. 37309
Material: Neoprene/polychloroprene
Properties
- 100% polychloroprene
- sterile
- packed in pairs in foil
- hand specific
Advantages
- adequate surface cleanliness
- very good form fit
- very high elasticity
- high permeation time with disinfectants
- tested with cytostatics
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 |
100% chloroprene rubber (CR) | |||
| Perforation-free |
AQL Piping stage |
1.5 2 | EN 374-2:2015 | |
| Tear resistance |
before ageing after accelerated ageing | N min./typical |
n.s./n.s. n.s./≥ 9 |
EN 455-2:2015 EN 455-2:2015 |
| Extreme elongation |
before ageing after accelerated ageing |
% min. |
n.s n.s. |
EN 455-2:2015 EN 455-2:2015 |
|
Dimensions nominal single wall thickness |
fingertips palm cuff | mm |
0.18 0.16 0.12 | |
| Length (+/- 10 mm) | mm typical | 300 | EN ISO 21420:2020 | |
|
Size/palm size nominal (+/- 5 mm) |
6 6.5 7 7.5 8 8.5 9 | mm |
77 83 89 95 102 108 114 | EN ISO 21420:2020 |
|
Size/Hand circumference nominal |
6 6.5 7 7.5 8 8.5 9 | mm |
n.s. | EN ISO 21420:2020 |
| Extractable particles | ≥ 0.5 µm |
number/cm2 typical | < 1,500 | IEST-RP-CC005.4 |
| Sterilization |
Sterility Assurance Level (SAL) for unopened/not damaged PE bag/ MHD 5 years from date of manufacture | 10-6 | ISO 11137-1:2006 | |
|
Endotoxins detected by LAL test, kinetic turbidimetric |
Endotoxin units (EU) per pair | < 20 | EN 455-3:2015 | |
| Biocompatibility | n.s. |
Epicutaneous test according to Buehler + Primary Skin Irritation Tests | ||
|
Glove-related allergies sensitization of water-soluble natural latex proteins (type 1 allergy) | µg/g | ≤ 50 | EN 455-3:2015 | |
|
Silicones, amides, Di-n-octyl phthalate (DNOP) | not detectable |
IEST-RP-CC005.4 FTIR measurement method | ||
| Powder-free | µg/gloves | compliant | ISO 21171:2006 | |
| Non volatile residues (NVR) | µg/g | max. 30 | IEST-RP-CC005.4 | |
|
Extractable ions NN = not detected NT = not tested | 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 typical 0.004 NN 3.000 0.899 NT NN NT NN 0.028 3.841 NN NN 0.583 0.410 0.079 0.062 |
IEST-RP-CC005. 4 |
|
ESD properties surface resistance contact resistance charge decay electrostatic properties (construction + material requirements) | n.s | EN 1149-1:2006 EN 1149-2:1997 EN 1149-3:2004 EN 1149-5 | ||
| Food contact |
suitable |
Regulation (EC) 1935/2004 + Regulation (EC) 2023/2006 | ||
|
Permeation resistance of medical gloves for chemotherapeutic agents | compliant | ASTM D6978 | ||
| PU |
100 pairs 1 pair per PE flat bag in a sealed PE bag, 10 pair/10 PE bags per sealed large bag | |||
| Cardboard quantity |
200 pairs 20 big bags |