Isolation Gown Level 2 Sewn – PP35+PE28

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Product Standard: EN13795-1:2019 and ANSA/AAMI PB70:2012
Factory ISO: 13485:2016 TGA / FDA
CE Certificate
Testing entity: Intertek (GZHT02282380) & SGS (SL52025257853301TX)

             

Category:

Description

Material: Non-woven sewn
Description: Single use, disposable, non-sterile intended for use in infection control practices to reduce the potential exposure to blood and body fluids.
Sterilisation: Non-sterile
Size: Small to 3XL
GW: 21.52Kg
Outer Box Dimensions: 66cm x 52cm x 34cm
Qty Per Carton: 130
Box Printing: Outer
MOQ: 10,000
Colour: Blue
Intertek EN13795-1:2019
Resistance to Dry Microbial Penetration (CFU) (EN ISO 22612:2005) Shell requirement ≤300 Result: 0
Cleanliness Microbial / Bioburden (CFU) (EN ISO 11737-1:2018) Requirement ≤300 Result: 159.6
Particles Release (EN ISO 9073-10) Requirement ≤4.0 Result:1.39
Bursting Strength Dry (kPa) (EN ISO 13938-11:1999) Requirement ≥40 Result: 146.8
Tensile Strength Dry N (EN 29073-3:1992) Requirement ≥20 Result: 49.6
SGS ANSA/AAMI PB70:2012
Water Resistance: Impact Penetration Test (AATCC 42-2017) Requirement: critical zone components shall have a blotter weight gain of no more than 1.0g Result:
Area A Critical zone front 0.0g
Area C Critical Zone back 0.0g
Water Resistance: Hydrostatic Pressure Test (AATCC 127-2018) critical zone components shall have a hydrostatic resistance of at least 20 cm H2O Result:
Area A Critical zone front:  >20 cm H2O
Area C Critical zone back: >20 cm H2O
Final Classification:
Area A Critical zone front:  Level 2
Area C Critical zone back: Level 2