Nitrile Gloves Sempercare Velvet Medium x 100
sempercare® velvet (Sempermed)
Nitrile GlovesPowder-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).
- 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.
- 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).
- 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
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.
- 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.
Composition
- Material: Nitrile Butadiene Rubber (NBR), 100% nitrile, latex-free.
- Colour: Violet blue.
- Internal finish: Powder-free.
- Glove surface: Finger textured.
- Glove shape: Flat with rolled rim, ambidextrous.
- 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).
