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Dastex Group GmbHDastex Group GmbH

BioClean Fusion™ Sterile

Polychloroprene glove

To this glove in our product portfolio

Facts


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Surface cleanliness
Grip
Elongation
Endotoxin pollution
Ion-free
Cytostatics compatible
Chemical protection
sterile
textured
hand specific

Neoprene/polychloroprene

BioClean™ Fusion S-BFAP, Art. No. 37303

Material: Neoprene/polychloroprene

Properties

  • 100% polychloroprene
  • sterile
  • packed in pairs in a peef-off pouch
  • ambidextrous

    Advantages

    • satisfactory surface cleanliness
    • very good form fit
    • very high ductility
    • high permeation time with disinfectants
    • tested with cytostatics
    • 2 times tightenable

    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

    123456789low dust

    Hygiene zones according to GMP
    microbiological monitored areas

    ABCDE

    PPE

    Personal protective equipment
    Regulation (EU) 2016/425

    Cat. ICat. IICat. IIInot aplicable

    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 measurementValueTest method
    Material     100%
    polychloroprene     		 
    Perforation-free   AQL
    Piping stage     		0.65
    3     		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 + ASTM D412-15a
    ASTM D573-04(2015)
    Dimensions
    nominal single wall thickness     		fingertips
    palm
    cuff     		  mm 0.12
    0.10
    0.07
    Length (+/- 10 mm)   mm typical 300 EN ISO 21420:2020
    Size/palm size
    nominal (+/- 5 mm)     		5 - 5.0
    6 - 6.5
    7 - 7.5
    8 - 8.5
    9
    10     		mm 76
    86
    95
    106
    115
    120
    		 EN ISO 21420:2020
    Size/Hand circumference
    nominal     		5 - 5.0
    6 - 6.5
    7 - 7.5
    8 - 8.5
    9
    10     		mm n.s.
    		 EN ISO 21420:2020
    Extractable particles ≥ 0.5 µm number/cm2
    typical     		< 850 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  
    Powder-free   µg/glove n.s.  
    Non-volatile residue (NVR)   µg/g n.s.  
    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, 003
    NN
    0.652
    0.194
    NT
    NN
    NT
    NN
    0.007
    0.884
    NN
    NN
    0.315
    0.099
    0.025
    NT
    		 IEST-RP-CC005. 4

    ESD properties
    surface resistance
    contact resistance
    charge decay
    electrostatic properties
    (design + 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
    chemotherapeutics     		    n.s. 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    		  
    Carton quantity     200 pairs
    20 big bags     		 

    The manufacturer's technical data listed above are typical values at the time of publication. They are not specifications. All data are without guarantee, changes are possible without prior notice.

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