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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.

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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

  • Single-use medical device class IIa as set out in EU MDR 2017/745
  • Single-use protective glove – PPE category III (protection against low chemical risks, microorganisms and ionizing radiation*) as set out in PPE Regulation EU 2016/425

 

*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.

 

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