Nitrile Examination Gloves Powder-Free Black (100)
Référence |
127563 |
Features
- Powder-free nitrile examination gloves for single use, black in colour.
- Box of 100 gloves adapted for intensive professional use.
- Protection against cytotoxic agents tested according to ASTM D6978-05 standard.
- 45 chemotherapy molecules blocked for more than 240 minutes out of 47 cytotoxic agents evaluated.
- Results validated by ARDL laboratory accredited ISO 17025 (Akron, Ohio).
- Documented permeation with breakthrough of carmustine at 22.9 minutes and thiotepa at 38.4 minutes.
- Adapted for the preparation of anticancer drugs in hospital pharmacy according to internal protocols.
- Dual certification: Class I Medical Device (EU Regulation 2017/745) and Personal Protective Equipment Category III Type B (EU Regulation 2016/425).
- Compliant with EN 374-5 standard offering protection against bacteria and viruses.
- Compatible with food contact in accordance with Regulation (EU) No 10/2011.
- Compliant with French decree of 05/08/2020 relating to materials intended for food contact.
- Controlled overall migration with results below regulatory limits of 60 mg/kg.
- Low heavy metal content: arsenic, cadmium, lead, mercury and antimony below 1 mg/kg each.
- Black colour facilitating visual contrast during dental care, technical procedures or laboratory handling.
- Powder-free limiting risks of particulate contamination.
- Multi-purpose use in hospital pharmacy, dental surgeries, laboratories, healthcare facilities, food industry and collective catering.
When protection leaves no room for compromise, SENSISKIN® black glove is there with measured and documented performance.
| Technical characteristics | Details |
|---|---|
| Product | Powder-free nitrile examination glove |
| Brand | SENSISKIN® |
| Packaging | Box of 100 gloves |
| Colour | Black |
| Material | Nitrile |
| Powder | Powder-free |
| Use | Single use |
| Medical classification | Class I Medical Device – Regulation (EU) 2017/745 |
| PPE classification | Category III Type B – Regulation (EU) 2016/425 |
| Microbiological standard | EN 374-5 (protection against bacteria and viruses) |
| Cytotoxic permeation test | ASTM D6978-05 |
| Permeation results | 45 cytotoxic agents out of 47 with no detectable breakthrough after 240 minutes; Carmustine: 22.9 minutes; Thiotepa: 38.4 minutes |
| Food compatibility | Compliant with Regulation (EU) No 10/2011 and French decree of 05/08/2020 |
| Overall migration | Below the regulatory limit of 60 mg/kg |
| Heavy metals | Arsenic, cadmium, lead, mercury and antimony below 1 mg/kg each |
| Fields of use | Hospital pharmacy, oncology, laboratories, dental surgeries, healthcare facilities, food industry, collective catering |
Is this nitrile glove suitable for handling chemotherapy drugs?
Yes. It has been tested according to ASTM D6978-05 standard and resists 45 of the 47 cytotoxic agents evaluated for more than 240 minutes.
Which chemotherapy agents show breakthrough before 240 minutes?
According to the tests performed, only carmustine shows breakthrough at 22.9 minutes and thiotepa at 38.4 minutes.
Is the glove compliant with medical laboratory requirements?
Yes. It complies with EN 374-5 standard attesting protection against penetration of bacteria and viruses.
Can this glove be used for food contact?
Yes. It complies with Regulation (EU) No 10/2011 and French decree of 05/08/2020 relating to materials intended for food contact.
Why choose black examination gloves?
Black colour improves visual contrast and masks residues, particularly in dental surgeries, laboratories or during technical procedures.
Is this glove both a medical device and PPE?
Yes. It benefits from dual classification: Class I medical device and Personal Protective Equipment Category III Type B.
Does the glove contain powder?
No. It is entirely powder-free to limit particulate contamination and improve ease of use.
In which sectors can this nitrile glove be used?
It is suitable for healthcare facilities, hospital pharmacies, dental surgeries, laboratories, food industries and collective catering.