STERILE: Biocontamination controlSterile cleanroom gloveCategory III PPE glove (PPE Directive 89/686/EEC)Complex Design - For mortal & irreversible risksPowder-free white nitrile gloveHand-specific400 mm / 0.12 mm (EN 420:2003 + A1:2009)AQL 0.65 (EN 374-2:2014 Level 3)Viral penetration test (ISO 16604:2004 Procedure B & ASTM F1671-97b)Waterproof and for low chemical protectionTested for chemical permeation (EN 16523-1:2015 supersedes EN 374-3:2003)Typical particle levels: less than 900 per cm² ≥ 0.5µmTested according to EN 1149-1-2-3 & 5Type I hypersensivity eliminated - Type IV hypersensivity reduced
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).Compatible with sterile processing environments due to paperless packaging and multiple post leaching of glovesTerminally 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”.Low Endotoxin content at < 20EU/Pair (EN 455-3:2015) demonstrated by Limulus Amoebocyte Lysate (LAL) kinetic turbidimetric test.FTIR: Non detectable levels of silicone, amide and DOP (IEST-RP-CC005.4). NVR: maximum 30mg/g (IEST-RP-CC005.4). Extensively tested for chemical permeation according to EN 16523-1:2015
| Characteristics | Value | Test Method | ||
|---|---|---|---|---|
| Freedom from holes | <0.65 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 | 0.15 | 5.9 | |
| Palm | 0.12 | 4.7 | ||
| Cuff | 0.10 | 4.0 | ||
| Length | 400mm, min. | 405mm, typical |
Particles |
Test Method |
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|---|---|---|---|---|
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Specification |
Typical value |
|
Particles |
Per cm²≥0.5µm |
<1.200 particles |
900 particles |
IEST-RP-CC005.4 |
SHIELDSKIN XTREME™ STERILE WHITE NITRILE 400 DI+ |
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Size |
Cat No |
Qty |
|---|---|---|
Extra Small (XS/6) |
69 8772 |
20 pouches per sealed PE bag - 8 PE bags per case (160 pairs) |
Small (S/7) |
69 8774 |
20 pouches per sealed PE bag - 8 PE bags per case (160 pairs) |
Medium (M/8) |
69 8776 |
20 pouches per sealed PE bag - 8 PE bags per case (160 pairs) |
Large (L/9) |
69 8778 |
20 pouches per sealed PE bag - 8 PE bags per case (160 pairs) |
Extra Large (XL/10) |
69 8779 |
20 pouches per sealed PE bag - 8 PE bags per case (160 pairs) |
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.
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.
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.
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 |
Packaging designed to comply with sterile processing environments. Gloves pair packed in a sealed polyethylene pouch. Twenty (20) pouches per sealed (double) poly bag. Eight (8) poly bags per double walled shipping case. Total of 160 pairs per outer case.
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
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.
