Powder-free nitrile examination and protective gloves
Certifications
Medical Device: Class I medical device as set out in EU Medical Device Regulation (MDR) 2017/745.
Personal Protective Equipment: Single Use protective glove, PPE Category III as per PPE Regulation (EU) 2016/425 (limited Time protection against chemical substances).
Conforms to EN 455 1, EN 455 2, EN 455 3, EN 455 4 (medical gloves for single use).
Medical Device: Class I medical device as set out in EU Medical Device Regulation (MDR) 2017/745.
Personal Protective Equipment: Single Use protective glove, PPE Category III as per PPE Regulation (EU) 2016/425 (limited Time protection against chemical substances).
Conforms to EN 455 1, EN 455 2, EN 455 3, EN 455 4 (medical gloves for single use).
Conforms to EN ISO 21420 (general requirements and test methods for protective gloves).
Conforms to EN ISO 374 1 (Type B), EN ISO 374 2, EN 16523 1, EN ISO 374 4, EN ISO 374 5 (protective gloves against dangerous chemicals and micro Organisms).
Description
Sempercare® Velvet Nitrile Gloves (Medium, box of 100) are lightweight, extremely soft, powder-free examination and disposable protective gloves made from nitrile butadiene rubber (NBR). They provide a latex-free alternative that combines exceptional wearing comfort with the necessary force at break. The soft violet-blue nitrile formulation wears like a second skin and is especially suitable for people with sensitive skin. These non-sterile, ambidextrous gloves feature finger-textured surfaces, a flat shape with rolled rim, and are classified both as a Class I medical device and as PPE Category III for protection against chemicals and micro-organisms. They are suitable for a wide range of clinical, laboratory, dental, care and aesthetics applications, and are additionally approved for food contact. Each box contains 100 medium-size gloves.
Bnefits
Lightweight and extremely soft nitrile formulation for high wearing comfort and a comfortable fit.
Latex-free composition, suitable for users with latex allergy or sensitivity.
Soft nitrile material wears like a second skin and is especially suitable for people with sensitive skin.
Powder-free, reducing risk of powder-related irritation and contamination.
Finger-textured surface to enhance grip and tactile sensitivity, even in moist environments.
Non-sterile, ambidextrous design for efficient, flexible use in examination and general protection.
Meets EN 455 requirements for medical gloves for single use, providing medical-grade barrier protection.
Meets EN ISO 374 chemical protection standards, protecting against dangerous chemicals and micro-organisms.
Dual-status product: Class I medical device under EU MDR 2017/745 and PPE Category III under PPE Regulation (EU) 2016/425.
Suitable for food contact according to Regulation (EC) 1935/2004 on Food Contact Materials.
Barrier performance with AQL 1.0–1.5 for pinholes (depending on batch/pack type), ensuring a low defect rate.
5-year shelf life when stored in original packaging under recommended conditions, supporting long-term stockholding.
Indications
General medical and clinical examinations requiring disposable, non-sterile medical gloves.
Conforms to EN ISO 21420 (general requirements and test methods for protective gloves).
Conforms to EN ISO 374 1 (Type B), EN ISO 374 2, EN 16523 1, EN ISO 374 4, EN ISO 374 5 (protective gloves against dangerous chemicals and micro Organisms).
Tested according to ASTM D6319 and ASTM F1671/F1671M (resistance to penetration by blood Borne pathogens).
Suitable for food contact in accordance with Regulation (EC) 1935/2004 on Food Contact Materials.
Manufactured under Sempermed/Harps quality management and regulatory systems applicable to medical devices and PPE.
Tested according to ASTM D6319 and ASTM F1671/F1671M (resistance to penetration by blood Borne pathogens).
Suitable for food contact in accordance with Regulation (EC) 1935/2004 on Food Contact Materials.
Manufactured under Sempermed/Harps quality management and regulatory systems applicable to medical devices and PPE.
Powder-free nitrile examination and protective gloves
Use in hospitals, primary care, outpatient clinics and diagnostics laboratories.
Dental procedures and hygiene tasks needing good tactile sensitivity and chemical splash protection.
Nursing and long-term care environments where frequent glove changes and comfort are important.
Aesthetic medicine, dermatology and cosmetic procedures requiring latex-free examination gloves.
Food handling and preparation where gloves compliant with food contact regulations are required.
Professional cleaning and hygiene tasks where protection from micro-organisms and certain chemicals is necessary.
Known accelerators: contains dithiocarbamate-type accelerators (should not be used by individuals hypersensitive to these substances).
Formulation
Non-sterile, powder-free nitrile examination and disposable protective glove for single use.
Material: Nitrile Butadiene Rubber (NBR), latex-free, with reduced wall thickness for improved comfort.
Overall length (size M): median 240 mm as per EN 455-2.
Wall thickness (single layer, palm area): minimum approximately 0.05–0.06 mm (typical 0.06 mm).
Tightness: AQL 1.0 for pinholes as per EN 455-1 (some marketed packs may still reference AQL 1.5).
Force at break: median ≥ 6 N as per EN 455-2.
Shelf life: 5 years in original packaging if stored according to product specification.
Conformity to standards: EN ISO 21420, EN ISO 374-1 (Type B), EN ISO 374-2, EN 16523-1, EN ISO 374-4, EN ISO 374-5, EN 455-1, EN 455-2, EN 455-3, EN 455-4, ISO 2859-1, ASTM D6319, ASTM F1671/F1671M.
Packaging
Box (dispenser) containing 100 medium-size gloves (by count, not pairs).
Available sizes: XS, S, M, L (typically 100 pieces per box), XL (typically 90 pieces per box) depending on configuration.
Dispenser boxes typically supplied 10 per shipping carton (1,000 gloves per carton for sizes XS–L).
Medisave product configuration: Nitrile Gloves Sempercare Velvet - Medium x 100, violet blue.
Usage
Select the correct size (Medium) based on hand measurements and manufacturer size guide; ensure a snug but comfortable fit.
Inspect gloves before use; do not use if the glove is torn, discoloured, or shows signs of damage.
Don gloves onto clean, dry hands, avoiding sharp objects or long nails that could puncture the glove.
Use as a single-use examination and protective glove; change gloves between patients, procedures, and whenever contaminated.
Avoid contact with aggressive chemicals beyond those covered by the manufacturer’s chemical resistance information, and respect any recommended maximum use times.
After use, carefully remove gloves to avoid skin contact with the outer (contaminated) surface, and dispose of according to local clinical or hazardous waste regulations.
Do not re-use, wash, or disinfect disposable gloves; they are designed strictly for single use.
Users with known hypersensitivity to nitrile or dithiocarbamate accelerators should avoid use; monitor skin for irritation during repeated wear.
Contraindications
Do not use in individuals with known hypersensitivity or allergy to nitrile butadiene rubber (NBR) or to dithiocarbamate-type accelerators.
Not suitable as a sterile surgical glove; for sterile procedures use appropriate sterile gloves.
Not intended for protection against all types of highly aggressive chemicals or prolonged chemical immersion; always consult the manufacturer’s chemical resistance list for compatibility.
Do not use damaged, expired, or improperly stored gloves, as barrier protection may be compromised.
Adverse Effects
Possible local irritation or contact dermatitis, particularly in individuals with sensitive skin or allergy to glove components.
Rarely, allergic reactions (including delayed-type hypersensitivity) may occur due to chemical accelerators or other additives.
Excessive sweating, maceration, or discomfort may occur during prolonged wear, especially in warm environments.
Storage Conditions
Store in original packaging in a cool, dry place away from direct sunlight and sources of ozone or intense artificial light.
Recommended storage temperature: generally below 40°C, away from excessive heat or frost.
Keep away from solvents, oils, and other chemicals that might degrade the glove material.
Do not store in very humid conditions or where the carton may become wet or physically damaged.
Observe the expiry date on the box; do not use gloves beyond their marked shelf life (typically 5 years from manufacture).
