EN 420:2003 + A1:2009 (Protective gloves – general requirements).
EN 374 (protection against chemicals and micro Organisms – specific parts as listed in product documentation).
EN 388 (limited mechanical risk performance – where stated in technical data).
EN 455 Parts 1–4 (Medical gloves for single use).
EN 420:2003 + A1:2009 (Protective gloves – general requirements).
EN 374 (protection against chemicals and micro Organisms – specific parts as listed in product documentation).
EN 388 (limited mechanical risk performance – where stated in technical data).
EN 1186 (Materials and articles in contact with food – food contact approved).
Description
Aurelia Transform Nitrile Gloves are high-quality ice blue, powder-free examination gloves supplied in an eco-packed box of 200. Made from thin yet durable nitrile, they provide higher tensile strength and barrier protection than typical latex or vinyl examination gloves while maintaining excellent comfort, flexibility and tactile sensitivity. The gloves are finger-textured for improved grip, feature a beaded cuff, are non-sterile, ambidextrous and completely latex-free, with an AQL of 1.5 and compliance with EN455 and relevant PPE standards.
Bnefits
High tensile strength and puncture resistance compared with latex and vinyl examination gloves.
Thin 3.2 mil nitrile construction designed to maximise comfort, flexibility and tactile sensitivity.
Powder-free and 100% latex-free formulation to minimise risk of powder-related complications and latex allergy.
Finger-textured surface to enhance grip and instrument control in wet or dry conditions.
Beaded cuff to improve donning and reduce risk of tearing or fluid roll-back.
Medical examination glove meeting EN 455 (parts 1–4) for single-use medical gloves.
Certified under relevant PPE regulations (Category III) for protection against chemical and biological hazards.
Approved for food contact (EN 1186), allowing safe use in food handling environments.
Chemo-rated / suitable for use with certain cytotoxic and chemotherapy drugs (splash resistance – refer to product sheet for tested agents).
Eco-packed 200-glove dispenser box to save storage space and reduce packaging waste.
Automated packing system intended to improve single-glove dispensing and reduce cuff tangling.
Available in a full size range (XS–XL) to optimise fit and reduce hand fatigue during prolonged wear.
EN 1186 (Materials and articles in contact with food – food contact approved).
PPE Directive 89/686/EEC / PPE Regulation (EU) 2016/425 – Category III (complex design PPE).
Medical Device Directive 93/42/EEC – Class I medical device (now under transition to MDR 2017/745 where applicable).
Manufactured in facilities certified to ISO 9001 and ISO 13485 quality management standards (Supermax Group).
Chemo Tested for use with selected cytotoxic and chemotherapy drugs (splash resistance – refer to manufacturer’s chemical resistance and ASTM D6978 testing where available).
PPE Directive 89/686/EEC / PPE Regulation (EU) 2016/425 – Category III (complex design PPE).
Medical Device Directive 93/42/EEC – Class I medical device (now under transition to MDR 2017/745 where applicable).
Manufactured in facilities certified to ISO 9001 and ISO 13485 quality management standards (Supermax Group).
Chemo Tested for use with selected cytotoxic and chemotherapy drugs (splash resistance – refer to manufacturer’s chemical resistance and ASTM D6978 testing where available).
Powder-Free Nitrile Examination Gloves
Laboratory work involving biological fluids and low-to-moderate risk chemicals as specified in the EN 374 test list.
Food handling and food preparation tasks where a food-safe, powder-free, disposable glove is required.
General hygiene, cleaning and infection-prevention tasks where chemical and microorganism protection to tested standards is needed.
Use by individuals with latex allergy who require a latex-free examination glove.
Handling of certain cytotoxic or chemotherapy agents where the glove’s chemo test profile is appropriate (refer to the manufacturer’s chemical resistance table and breakthrough times).
Composition
Nitrile butadiene rubber (synthetic nitrile).
Colorant / pigment to give the characteristic ice blue or TransBlue colour.
Processing additives and accelerators used in nitrile glove manufacture (no natural rubber latex proteins, no donning powder).
Formulation
Powder-free, synthetic nitrile examination glove.
Approximate thickness: 3.2 mil (single-wall, palm) with slightly greater thickness at the fingers for durability.
Non-sterile, ambidextrous design with finger-textured surface and beaded cuff.
100% latex-free formulation to reduce risk of Type I latex hypersensitivity.
Packaging
200 gloves per dispenser box (by weight, count approximate).
10 dispenser boxes per shipping case (approximately 2000 gloves per case).
Eco-packed compact carton design intended to reduce storage space and packaging waste.
Gloves packed for single-glove dispensing from the box.
Usage
Select the correct size (Small for this SKU) using the manufacturer’s sizing guidance to ensure a close but comfortable fit.
Inspect the dispenser box seal and individual gloves for damage or visible defects before use; do not use damaged gloves.
Ensure hands are clean and dry before donning; avoid hand creams or oils that may degrade the glove material.
Grasp the glove by the cuff and insert the fingers, then pull over the wrist using the beaded cuff, taking care not to tear the material.
Use the gloves for single-use procedures only; change gloves between patients, between different tasks on the same patient, and immediately if torn, punctured or visibly contaminated.
Avoid contact with chemicals or cytotoxic agents not listed as tested or compatible in the manufacturer’s chemical resistance information.
After use, remove gloves by peeling from the wrist and turning inside out, avoiding contact between the contaminated outer surface and skin.
Dispose of used gloves safely in accordance with local clinical waste, laboratory or infection-control protocols.
Wash or sanitise hands after glove removal.
Contraindications
Known or suspected hypersensitivity or allergy to nitrile butadiene rubber or any component chemicals (e.g., certain accelerators, additives or pigments) used in the glove formulation.
Situations requiring sterile surgical gloves or where a sterile barrier is mandated by protocol.
High-risk or extended chemical immersion scenarios that exceed the glove’s tested chemical resistance or breakthrough times.
Use with chemotherapy or cytotoxic drugs that have not been specifically tested or listed as compatible by the manufacturer.
Applications requiring cut-resistant or heat-resistant hand protection beyond the scope of disposable examination gloves.
Adverse Effects
Potential for skin irritation or contact dermatitis from prolonged occlusion, perspiration or sensitivity to glove additives.
Rare allergic or hypersensitivity reactions to nitrile or residual processing chemicals (e.g., redness, itching, rash).
Discomfort or hand fatigue if incorrect glove size is used or gloves are worn for prolonged periods without breaks.
Inadequate protection and increased risk of contamination or exposure if gloves are damaged, used beyond recommended indications or not changed between tasks.
Storage Conditions
Store in a cool, dry and clean environment.
Avoid excessive heat; do not store above approximately 40°C (104°F).
Keep away from direct sunlight and strong fluorescent lighting, especially for open boxes.
Protect from ozone-generating equipment, moisture, oils and solvents that may degrade the glove material.
Keep boxes in their original packaging until use and rotate stock using first-in, first-out (FIFO) principles, observing any printed expiry dates.
Duration
Single-use; intended to be worn only for the duration of a clinical, laboratory, hygiene or handling task and then discarded. Not designed for extended or repeated use.
Onset
Immediate barrier protection and grip enhancement are provided as soon as the gloves are correctly donned.
