SHIELDSKIN XTREME™ NON STERILE WHITE NITRILE 400 DI+

Product Information

  • DI+: High contamination control
  • Non-sterile clean room glove
  • Category III PPE glove (PPE Directive 89/686/EEC)
  • Complex Design - For mortal & irreversible risks
  • Powder-free white nitrile glove
  • Ambidextrous
  • 400 mm / 0.15 mm (EN 420:2003 + A1:2009)
  • AQL 1.5 (EN 374-2:2014 Level 2)
  • Viral penetration test (ISO 16604:2004 Procedure B & ASTM F1671-97b)
  • Waterproof and for low chemical protection
  • Tested for chemical permeation (EN 16523-1:2015 supersedes EN 374-3:2003)
  • Typical particle levels: less than 950 per cm² ≥ 0.5µm
  • Tested according to EN 1149-1-2-3 & 5
  • Type I hypersensivity eliminated - Type IV hypersensivity reduced

Additional Data

  • Biocompatibility demonstrated by Modified Buehler and Primary Skin Irritation Tests.
  • Non detectable levels of chemical allergens using aqueous solution extraction (Phosphate buffered solution)• and High Performance Liquid Chromatography (HPLC) assay method for quantitative analysis.
  • Free of Thiurams and Thiazoles – these chemical accelerators are excluded from the manufacturing process.
  • Powder free to minimize the potential consequences of powder-borne dermatitis.
  • Residual powder content is 1.0 mg/glove (typical) with a limit of 2.0 mg/glove (ISO 21171:2006 “Medical gloves – Determination of removable surface powder”).
  • Micro-organism and virus resistant – passes highest level of micro-organism resistance per EN 374-2:2014• (Performance level 3, AQL < 0.65 and inspection level G1 according to 1000ml water test) and passes viral penetration test using Phi-X 174 bacteriophage (ISO 16604:2004 Procedure B & ASTM F1671-97b).
  • FTIR: Non detectable levels of silicone, amide and DOP (IEST-RP-CC005.4).
  • Surface Resistivity: 108 – 1010 Ω/sq. (ASTM D257-14)
  • NVR: maximum 30mg/g (IEST-RP-CC005.4).
  • Tested for electrostatic properties according to EN 1149-1/2/3 & 5
  • Extensively tested for chemical permeation according to EN 16523-1:2015

Technical Data

Characteristics Value Test Method
Freedom from holess <1.5 AQL1 EN374:2003
Tensile Properties Tensile Strength (min) Typical Elongation Ultimate EN 455-2:2015, ASTM D573-04(2015) and ASTM D412-15a
Before Aging 6.0N, min. 7.0N 500%, min.
After Accelerated Aging 6.0N, min. 8.0N 400%, min.
Dimensional Measured Point Mm mil ASTM D3767-03(2014)

EN 420: 2003 + A1: 2009
Nominal Thickness Middle Finger 0.2 7.9
Palm 0.15 6.0
Cuff 0.10 3.9
Length 385mm, min. 400mm, typical

Cleanliness Properties

Particles

Test Method

 

 

Specification

Typical value

 

Particles

Per cm²≥0.5µm

<1.200  particles

900 particles

IEST-RP-CC005.4

Ordering Information

SHIELDSKIN XTREME™ STERILE WHITE NITRILE 400 DI+

 

Size

Cat No

Qty

Extra Small (XS/6)

69 8671

Ten (10) poly bags per inner bag. Packed in a doublewalled shipping case. 1000 gloves per case

Small (S/7)

69 8672

Ten (10) poly bags per inner bag. Packed in a doublewalled shipping case. 1000 gloves per case

Medium (M/8)

69 8673

Ten (10) poly bags per inner bag. Packed in a doublewalled shipping case. 1000 gloves per case

Large (L/9)

69 8674

Ten (10) poly bags per inner bag. Packed in a doublewalled shipping case. 1000 gloves per case

Extra Large (XL/10)

69 8675

Ten (10) poly bags per inner bag. Packed in a doublewalled shipping case. 1000 gloves per case

Quality Certification

REGULATORY COMPLIANCE

Whilst process protection is typically the main concern, increasingly users are recognising that there is often an equal need for personal protection of employees from chemicals and biohazards. The responsibilities of the employer are outlined in the PPE at Work Directive 89/656/EEC which is the enshrined in local legislation throughout the European Union (EU). To address this need, all SHIELDskin / SHIELDskin XTREME™ gloves are registered according to the PPE Directive 89/686/EEC.

EXCELLENCE IN ASEPTIC PROCESSING and BIO CONTAMINATION CONTROL

For users of sterile gloves, the SHIELDskin / SHIELDskin XTREME™ gloves offer the highest level of bio contamination control. SHIELD Scientific products provide superior process and personal protection from liquid penetration by micro-organisms (EN 374-2:2014) and viruses (ISO 16604:2004 Procedure B and ASTM F1671-97b). Acceptable Quality Level (AQL) is a crucial parameter for determining barrier properties. An AQL of 0.65 according to EN 374-2:2014 Level 3 represents over 50% less defects than comparable sterile gloves on the market.

Gloves certificates

As a guarantee of industry leading performance, we supply certificates on all our cleanroom gloves. The certificates of conformance (CoC) provide lot-specific data such as levels of particles and extractables, whilst for sterile gloves test data on endotoxin levels is also presented. The certificates of irradiation (CoI) are available for every lot of sterile cleanroom nitrile gloves and sterile cleanroom latex gloves.

Quality Analysis

Material

Synthetic soft nitrile polymer (Acrylonitrile Butadiene). Contains no natural rubber latex

Design

White, hand-specific, beaded cuff, with textured palm and fingers

AQL

AQL 0.65 ( EN 374-2:2014 Level 3)

Powder free

Minimize the potential consequences of powder-borne dermatitis. Residual powder content is 1.0 mg/glove (typical) with a limit of 2.0 mg/glove (ISO 21171:2006 “Medical gloves – Determination of removable surface powder”).

Micro-organism and virus resistant

passes highest level of micro-organism resistance per EN 374-2:2014 (Performance level 3, AQL<0.65  and inspection level G1 according to 1000ml water test) and passes viral penetration test using Phi-X 174 bacteriophage (ISO 16604:2004 Procedure B & ASTM F1671-97b

 PPE Category

PPE Category III (Complex Design) according to Council Directive 89/686/EEC.

Sterility

Terminally sterilized by gamma irradiation to Sterility Assurance Level (SAL) of 10-6 , in accordance with guidelines detailed in EN ISO 11137-2:2015 “Sterilization of Healthcare Products – Radiation”

 

Endotoxin content

Low End toxin content at <20 EU/pair (EN 455-3:2015) demonstrated by Limulus Amoebocyte Lysate (LAL) kinetic turbidimetric test.

Tested for electrostatic properties Tested for electrostatic  Properties according to EN 1149-1/2/3 & 5

 Certification

  Manufactured in accordance with ISO 9001:2015 and ISO 13485:2016

Packing

One hundred gloves (100) per inner poly bag. Packaging designed to comply with cleanroom environments processes. Gloves are flat-packed. Ten (10) poly bags per inner bag. Packed in a doublewalled shipping case. 1000 gloves per case.

Satisfaction Guarantee

For users of sterile gloves, the SHIELDskin / SHIELDskin XTREME™ gloves offer the highest level of bio contamination control. SHIELD Scientific products provide superior process and personal protection from liquid penetration by micro-organisms (EN 374-2:2014) and viruses (ISO 16604:2004 Procedure B and ASTM F1671-97b). Acceptable Quality Level (AQL) is a crucial parameter for determining barrier properties. An AQL of 0.65 according to EN 374-2:2014 Level 3 represents over 50% less defects than comparable sterile gloves on the market

Purchase Guarantee

BioStar offers a complete satisfaction guarantee so you can be confident of your purchasing decision. If, for any reason you are not satisfied with the product performance or service provided, we will either replace or issue a refund for the purchase price of your product.

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