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Product data sheet
IsoCoat Zytex®
The manufacturing meets the requirements for regulatory purposes
according to the directive 93/42/EEC for medical devices and the quality
management systems ISO 13485 and ISO 9001.
Product data (V.7)
REF:
424
Product:
Protective gown with knitted cuffs
Trademark:
SAFE®
Manufacturer:
DACH Schutzbekleidung GmbH & Co. KG
Classification:
Cat I Personal Protective Equipment Directive 89/686/EEC
Class I Medical Device Directive 93/42/EEC; UMDNS Code: 11-901
Product description:
The front and the sleeves of this gown are made of innovative Zytex® material and prevent the
penetration of viruses, chemicals, body fluids, dry and wet infectious agents. The back is made of
breathable nonwoven to allow highest comfort even when performing physical work. The
IsoCoat Zytex® has its opening on the backside and fastening belts at neck and waist level. The
sleeves with knitted cuffs allow an optimal fit when wearing gloves and prohibit them from
slipping.
Material:
Front part and sleeves:
Back part:
Knitted cuff:
Sewing thread:
Performance:
Class 6: ISO 16603, ASTM F 1670 (resistance to penetration by synthetic blood)
Class 6: ISO 16604, ASTM 1671 ( resistance to penetration by bacteriophage virus)
Class 6: EN 14126, EN ISO 22610 (resistance to bacterial penetration - WET Penetration)
Class 3: EN ISO 22612 ( resistance to penetration microbial penetration - DRY Penetration)
Class 3: ISO 22611 ( resistance to penetration by liquid aerosol)
Cytostatic resistant: ISO 6529 (resistance to permeation by liquid chemicals)
Application:
Infection control, protection against MRSA and noroviruses, handling cytostatic drugs
Zytex®
Polypropylene nonwoven
100% polyester
100% polyester 17 – 18 tex
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DACH Schutzbekleidung GmbH & Co. KG | www.dach-germany.de | Email: [email protected] | 28/05/15
Dermatological
tolerance:
No intolerance reaction
Size / Length:
M / 110 cm
L / 130 cm
Colour:
Apricot
Variants:
REF
Size
Units
Packaging
GTIN
424A/M
M
10 pcs.
Polybag
4049825002420
424A/M
M
50 pcs.
Shipping carton
4049825502418
424A/L
L
10 pcs.
Polybag
4049825002437
424A/L
L
50 pcs.
Shipping carton
4049825502425
Storage:
The product has a maximum storage life of approximately 10 years when stored at room
temperature, in a dry environment, without direct sun exposure and in its original packaging.
Disposal:
The disposal of this product is environmentally friendly. It can be disposed thermally or by landfill
without releasing toxic substances.
The disposal of contaminated products must be determined by its contamination and prevailing
laws and regulations.
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DACH Schutzbekleidung GmbH & Co. KG | www.dach-germany.de | Email: [email protected] | 28/05/15