sempermed® syntegra X
THE ADVANCED SOLUTION: A glove, designed with a unique material composition offering enhanced flexibility, excellent tactile sensitivity, prolonged wearing comfort, and reduced hand fatigue. It is ideal for reducing hand exposure to harmful scattered ionizing rays during fluoroscopic procedures.
Description
Syntegra X represents a significant advancement in radiation attenuation glove technology, prioritizing both safety and comfort for healthcare professionals. Radiation attenuating surgical gloves to reduce the exposure from harmful scattered ionizing rays on the operator´s hand during fluoroscopic procedures. These gloves are not to be used in or next to primary X-Ray beam.
The glove comes in two different models, with different thickness and level of attenuation.
Our surgical glove artwork has changed recently. Please find all information on the changes here.
Benefits
- X-CELLENT WEARING COMFORT
Our synthetic polyisoprene radiation attenuation glove provides sublime wearing comfort compared to other radiation attenuation gloves. Its textured finger micro-surface enhances flexibility and comfort for instrument handling.
- X–TRA SAFE
The proprietary tungsten composition of syntegra X is 75% denser than lead, offering superior attenuation ability than leaded gloves at equivalent thickness. Additionally, the glove is latex- and lead-free.
- X–CELERATOR OPTIMIZED
Formulated without DPG and MBT, which has recently been classified as a cancer-causing agent in California Prop-65. Syntegra X undergoes an extensive washing process to reduce residues of other manufacturing related chemicals.
Specifications
Type
Radiation attenuating surgical glove for single use, with synthetic inner coating
Material
Soft synthetic polyisoprene containing lead-free radiation attenuating tungsten alloy. Formulated without DPG and without MBT.
Internal finish
Powder-free polymer coated
Glove surface
micro-rough
Colour
Dark grey
Glove Shape
| Fully anatomical with curved fingers and rolled rim |
Size
Overall length as per EN 455-2
5 ½, 6, 6 ½, 7, 7½, 8, 8 ½ and 9 min. 285 mm
Wall thickness
Measured in single layer in the palm area
Model 1 – min. 0.24mm
Model 2 – min. 0.32mm
Barrier performance
Tightness as per EN 455-1
AQL 0.65
Force at break
exceeding EN 455-2
≥ 9.0 Newton
Shelf Life
in original packaging if stored according to product specification
3 years
Sterilisation
Irradiation
Labeling & CONFORMITY TO STANDARDS
EN455-1:2020, EN455-2:2024, EN455-3:2023, EN455-4:2009; EN 61331-1:2014; EN ISO 10993-5:2009; EN ISO 10993-10:2021; EN ISO 13485:2016, EN ISO 14971:2019, EN ISO 15223-1:2021, EN ISO 11607-2 :2020, EN ISO 11137-1:2015, EN ISO 11137-2 :2015, EN388:2016+A1:2018, EN ISO 21420:2020, EN421:2010 and EN374-1:2016, EN16523-1:2015+A1:2018, EN374-2:2014, EN374-4:2013 and EN374-5:2016
Packaging
1 pair with folded cuffs in folded bag protected against microbiological contamination.
5 pairs per dispenser box: 60 x 157 x 290mm
4 boxes per transport carton: 135 x 293 x 330mm
INTENDED PURPOSE
*Please note that all Sempermed products must be used in accordance with the Sempermed chemical resistance and the respective declaration of conformity. Failure to observe this information, in particular with regard to (chemical) resistance, frequency of use and tolerability of the gloves, can result in personal injury and/or material damage. HARPS is not liable for incorrect use of the gloves nor will HARPS be liable for improper storage and handling. In case of damage or unusual signs of wear and tear, gloves shall not be used. The information and classification is up to date as of the date of publication. Technical details are average values from production and may vary in individual cases. This disclaimer is subject to mistakes, printing errors and amendments. This product contains accelerators of Dithiocarbamate types. These products should not be used if hypersensitivity of these substances exists. For further information, a list of substances contained in the glove is available upon request. CAUTION: The gloves do not protect against mechanical risks (abrasion, cuts, tears, piercing, etc..) and against heat and fire. These gloves are not to be used in or next to the primary X-Ray beam. The choice of a suitable glove must be made according to the activity being performed, the type of risk and the related environmental condition. Radiation attenuation gloves offer limited protection to clinicians exposed to scattered radiation from patients during fluoroscopically guided procedures. The hands of the clinician should only be placed in the Field of View when required by the goals of the procedure, whether a radiation attenuation glove is used or not. These gloves contain elements of high atomic number and shall not be used to protect against radioelement of high beta energy so as to avoid bremsstrahlung. |
