Reference. 94145FREE1XX
Sterile surgical gloves made of radiation attenuating polyisoprene, 1 pair. Various sizes.
Surgical gloves made of polyisoprene and heavy metals designed to attenuate scattered radiation in fluoroscopic processes. Available in various sizes.
Description
These surgical gloves have been made with a unique blend of polyisoprene and heavy metals to ensure exceptional radiation attenuation. They do not contain lead or latex in their composition and have been designed with an ergonomic shape to ensure stable, comfortable, and safe use, both for the patient and the health professional. On the fingertips, they have a micro-textured surface designed to ensure a firm and controlled grip, making them suitable for use in procedures requiring high precision and sensitivity. All of this is accompanied by multiple ISO certifications that not only prove their effectiveness, but also guarantee that they are compatible with all types of interventions involving scattered radiation.
General features
- Polyisoprene and heavy metal gloves designed to protect hands
- Effective against scattered radiation during fluoroscopic procedures
- Suitable for protecting surgical wounds from contamination
- Ensure exceptional tactile sensitivity and unparalleled stability thanks to their anatomical shape
- Corresponding hand indicator printed for quick placement
- Provided with a micro-textured surface on the fingertips for optimal grip
- Lead and latex free
- Efficiency tested according to EN 61331-1:2015 and ASTM F2547-06 °1°
- Efficacy proven in 3 areas of the glove (fingers, palm and wrist)
- Biocompatibility according to ISO 10993 regulations
- Acute systemic cytotoxicity tests performed according to ISO 10993-5 and ISO 10993-12
- Viral penetration proven according to EN374-5 following the ISO 16604 method
- Tensile strength tested EN 455-2:2015 and elongation at break point according to ASTM D3577-19
- Sterilized and sterilizable only by ethylene oxide
- Classified as a class IIa medical device according to regulation (EU) 2017/745
- Certified as personal protective equipment category IIIB according to regulation (EU) 2016/425
- Manufacturer recognized according to ISO 13485 regulations
Technical specifications
- Glove thickness: 0.22 mm
- AQL: 0.65
- Sterility shelf life: 3 years (from the date of sterilization)
Regulations and certifications
- IEC 61331-1:2014
- EN 21420:2020
- ASTM F2547-18
- ASTM D3577-19
- EN 16523-1:2015
- ASTM F1671-22
- ASTM D7866-23
- EN 374 part 1, 2, 4 & 5
- ISO 16604:2004
- EN 455 part 1, 2, 3 & 4
- EN 421:2010
- ISO 10993-1:2018
- EN 388:2016
- CE marking 02777
- CE marking 0123
Attenuation properties (according to EN 61331-1:2014)
Size guide
General features
- Polyisoprene and heavy metal gloves designed to protect hands
- Effective against scattered radiation during fluoroscopic procedures
- Suitable for protecting surgical wounds from contamination
- Ensure exceptional tactile sensitivity and unparalleled stability thanks to their anatomical shape
- Corresponding hand indicator printed for quick placement
- Provided with a micro-textured surface on the fingertips for optimal grip
- Lead and latex free
- Efficiency tested according to EN 61331-1:2015 and ASTM F2547-06 °1°
- Efficacy proven in 3 areas of the glove (fingers, palm and wrist)
- Biocompatibility according to ISO 10993 regulations
- Acute systemic cytotoxicity tests performed according to ISO 10993-5 and ISO 10993-12
- Viral penetration proven according to EN374-5 following the ISO 16604 method
- Tensile strength tested EN 455-2:2015 and elongation at break point according to ASTM D3577-19
- Sterilized and sterilizable only by ethylene oxide
- Classified as a class IIa medical device according to regulation (EU) 2017/745
- Certified as personal protective equipment category IIIB according to regulation (EU) 2016/425
- Manufacturer recognized according to ISO 13485 regulations
Technical specifications
- Glove thickness: 0.22 mm
- AQL: 0.65
- Sterility shelf life: 3 years (from the date of sterilization)
Regulations and certifications
- IEC 61331-1:2014
- EN 21420:2020
- ASTM F2547-18
- ASTM D3577-19
- EN 16523-1:2015
- ASTM F1671-22
- ASTM D7866-23
- EN 374 part 1, 2, 4 & 5
- ISO 16604:2004
- EN 455 part 1, 2, 3 & 4
- EN 421:2010
- ISO 10993-1:2018
- EN 388:2016
- CE marking 02777
- CE marking 0123
Attenuation properties (according to EN 61331-1:2014)
| 60kV | 80kV | 90kV | 100kV | 120kV | |
| Wrist | 51% | 48% | 40% | 43% | 34% |
| Palm | 55% | 49% | 44% | 44% | 37% |
| Finger | 55% | 55% | 44% | 44% | 37% |
Size guide
| Size | Length (mm) | Width (mm) | Weight (g) | Surface (dm2) |
| 6½ | 295-305 | 83±5 | 31.5 | 10.2 |
| 7 | 295-305 | 89±5 | 32.5 | 10.7 |
| 7½ | 295-305 | 95±5 | 35.3 | 11.4 |
| 8 | 295-305 | 103±5 | 38.9 | 12.4 |

