Finessis | FAQ
Finessis | FAQ
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PART I: MATERIAL & TECHNOLOGY

What is Flexylon™?

Flexylon™ is a unique composition of high performance synthetic polymer, called “SBC”, that mimics natural rubber latex physical attributes without the drawbacks of latex proteins and chemical accelerators.

 

What is SBC?

SBC is the acronym of Styrenic-block-copolymer”, a broad range of synthetic high-performance elastomers capable to form elastic films without the need of chemical vulcanization.

 

What are the other commercial usages of SBC?

SBC are widely used in thousands of applications that require performance and flexibility, such as in aerospace, automotive, food and medical industries. Applications cover many usages such as pressure sensitive adhesives, stretch wrapping films, roofing felts, sealants, mastics, coatings to enumerate a few

 

What are the key benefits of Flexylon™ as compared to other materials?

Flexylon™ is an ultra-clean and ultra-soft alternative to both natural rubber and synthetic rubber latexes. It does not contain natural rubber latex proteins, nor any rubber processing chemicals such as accelerators or processing resins

 

What is “Molecular Layer Technology”?

Molecular Layer Technology (MLT), is a state-of-the-art technology derived from the concept of molecular layer deposition, in which molecules are deposited layer-by-layer forming very fined and uniform thin film. The MLT is capable to produce high-quality nanoscale thin films in molecular layer-by-layer manner. The molecular layers are deposited with controlled cycles to customize the film thickness. The film is not only pinhole free, dense and uniform but also conformal to complex 3-dimesional structures.

 

What is the difference between Molecular Layer Technology and “latex” conventional manufacturing process?

There is a significant difference in terms of barrier quality and integrity. Films made of latex material failed to reach a homogeneous structure and present intrinsic micro-porosity. This is because the initial raw material is a latex (which could be either natural rubber latex or synthetic latexes) which is a dispersion of polymer microparticles in water. Transforming a heterogeneous dispersion into a homogeneous film is not possible to perform with zero defects. Films made of latex have intrinsic micro-porosity. In presence of water, hydration of the glove leads to a sharp decrease of the barrier performance.

 

In contrary, Molecular Layer Technology offers the possibility to produce films with extremely high quality and.no porosity which are not sensitive to hydration.

 

Is Flexylon™ “cleaner” than other glove materials?

Flexylon™ does not contain any of the conventional chemicals used for other gloves such as natural rubber proteins, accelerators or processing resins, therefore definitely they can be considered as “cleaner”.

 

Is Flexylon™ resistant to bone cement?

Flexylon™ is made of SBC, a high-performance block copolymer capable of self-organize in form of elastic films without the use of vulcanization. Such mechanisms are governed by so- called “supramolecular chemistry” and are governed by the composition of the copolymer and the nature of the polystyrene segment that form rigid microdomains. The films may present potential weakness when exposed to low polarity organic solvents such as uncured bone cement.

 

For operation personnel involved in the preparation and use of harsh chemicals, bone cement or organic solvents, double gloving is recommended and are advised to choose the suitable type of glove as the contact glove, according to the chemical manufacturer’s Instruction for Use.

 

What is glove “blooming”?

A bloom is defined as a “thin layer on the surface of a rubber article from the chemicals either added before or produced during vulcanization, resulting in migration of the chemical from the bulk of the article to its surface”. Organic molecules such as accelerators and other curative agents have a limited but appreciable solubility in the elastomers. If these organic molecules are present at a concentration greater than their solubility at storage temperature, they will be rejected and slowly diffuse inside the glove polymer network towards the surface. This could be the case for accelerators. Increased concentrations of accelerators at the glove surface will pose greater risk for skin sensitization.

 

Is Finessis® glove compliant with REACH directive?

REACH (Regulation, Evaluation, Authorization of Chemicals) is a European Regulation entered into force from1 June 2007 with the aim to protect human health and the environment from harmful chemicals. REACH impose restrictions on most harmful chemicals. Finessis® is mostly composed of SBC, which is an” inert polymer” and does not contain any of so-called “substances of very high concern at a concentration greater than 0.1% “as defined by ECHA. In particular, Finessis® is compliant with REACH requirement regarding to Polycyclic Aromatic Hydrocarbons (PAH).

 

Is Finessis® glove compliant with Proposition 65?

Proposition 65, officially known as the Safe Drinking Water and Toxic Enforcement Act of 1986, was enacted as a ballot initiative in November 1986. The preposition protects the Californian state’s drinking water sources from being contaminated with chemicals known to cause cancer, birth defects or other reproductive harm and requires businesses to inform Californians about exposures to such chemicals. Proposition 65 requires the state to maintain and update a list of chemicals known to the state to cause cancer or reproductive toxicity. Finessis® glove does not contain any added substances listed in the Proposition 65.

PART II: PRODUCT & FUNCTIONS OF THE GLOVE

Which are the factors that can affect glove barrier properties?

Glove formulation, manufacturing processes, storage conditions and wearer’s care can all affect the barrier properties of gloves. Basically, all glove made of “latex” have some intrinsic micro-porosity that make them sensitive to hydration, a phenomenon that lead to a rapid decrease of their barrier performance. Glove degradation has been associated with heat, high humidity, oils, hand lotions, incompatible chemicals, UV light, sunlight, fluorescent lighting, X-ray machines and other ozone-generating sources such as electrical generators.

 

What are the most common hand issues related to the use of glove?

Glove associated reactions are frequent. There are 3 types of reactions: irritation, which is a non-allergic reaction, and two allergic reactions: a Type I hypersensitivity related to natural rubber latex proteins allergens, and a Type IV hypersensitivity related to chemicals.

 

How frequent are Type IV allergies?

Hundreds of substances have been identified as contact sensitizers or chemical allergens. Some can be found in gloves: Type IV allergic reaction can be due to chemicals added during glove manufacturing, mostly chemical accelerators (thiruams, thiazoles, carbamates, guanidine) but also processing agents such as processing resins (rosin resin). Delayed allergic reactions due to gloves remain frequent. Synthetic polyisoprene gloves have been associated with an increased risk of Type IV allergy.

 

What is “micro-porosity” and how it can affect glove barrier performance?

Current surgical gloves are all manufactured starting from dispersions of microparticles of polymer in water, called latex. Microporosity in the rubber film is attributed to failure of all latex particles making up a typical glove to completely coalesce with each other. Native proteins, surfactants and chemicals used in the manufacturing process are suspected of hindering coalescence. When in contact with water, a process called hydration happen, that lead to a rapid decrease of the barrier performance of the films.

 

Flexylon™ is manufactured starting from Molecular Layer Technology that is not affected to hydration.

 

What is “hydration” and how it affects glove properties?

Hydration can be defined as absorption of water into the latex film. All latex-based films have an intrinsic micro-porosity and contain significant amounts of chemicals residues, such as surfactants which tend to “capture” water when the film is exposed to blood, body fluids and from perspiration inside the glove. Waters diffuse through the channels and hydration significantly decreases the impedance (or electrical resistance) of gloves as well as its mechanical properties.

 

Flexylon™ is processed starting from Molecular Layer Technology, without the use of any chemicals and surfactants. Therefore, Flexylon™ is not impacted by hydration.

What is the mechanical performance of Flexylon™, as compared with other glove materials?

Flexylon™ gloves have been evaluated according to international standards for surgical gloves such as EN455 series, as well as standards for personal personal equipments (EN374 series). Test include mechanical resistance, tear resistance, chemical resistance, chemotherapy drugs, biocompatibility.

 

Flexylon™ offer the same level of properties as compared to polyisoprene gloves for example.

 

Flexylon™ is a synthetic rubber, is it the similar polymer material as polyisoprene?

Both materials exhibit very good feel-fit behaviors, but the “chemistry” and the transformation processes of these materials are different. The performance of Finessis® glove rely on the constitutive material itself, and on the transformation process of this material to make a glove.

 

Flexylon™ offers the following advantages as compared to Polyisoprene:

1. No accelerators, no processing resins

2. No micro-porosity and therefore no hydration.

 

Do you recommend double gloving with Finessis Zero®?

Yes. The Finessis® range has been designed for double gloving, which is a standard practice. Finessis Corium® is specifically designed to be used as an under-glove, but Finessis Zero® can also be used either as an under-glove or as standalone glove.

 

Flexylon™ is a synthetic material, will it cause more perspiration especially in long hours surgery?

Perspiration is a complex process and many parameters can influence it. So far, there is no specific complain regarding perspiration when Finessis gloves are used. Flexylon is softer than other gloves, it may contribute to minimize the force and the stress exerted on the skin.

 

Why do some gloves turn brown when put them on?

Glove discoloration is due to reaction between chemical residues and acidic perspiration. It is a way to “see” the chemicals on gloves. Flexylon™ gloves do not react as the material does not contain chemical residues.

 

How efficient is a conventional glove preventing infections in case of blood exposure accident with a sharp object?

Gloves are very thin membranes that cannot resist against penetration of sharps (needles, scalpel, bone fragments,…).

 

Donning two pairs of gloves allows a better protection of the internal glove and reduces its risk of being punctured by about two thirds. The use of a colored internal glove enables a better visualization of damage to the external glove. But increased awareness always prevails: a study showed that, in almost 50% of the cases, the two gloves could be micro punctured at the same location which would suggest that fluids are susceptible to go through.

 

Some puncturing objects can trigger a partial wiping effect by mechanical constriction process due to the glove elastic properties, which can help to reduce the volume of blood transferred. However, wiping is a complex process that depends on different parameters such as geometry, shape, porosity of the penetrating sharp as well as the glove material, thickness and tension. While wiping could work for suture needles, it cannot work on many other objects with a more complex geometry and shape than solid cylindrical tubes, such as scalpels, instruments, as well as all objects with cavity (hollow bore needles) or porosity (bone fragments). This allow the sharp to deliver its full load of contaminants posing therefore a much greater risk for transmission of infection.

 

Do you recommend a change of glove after 2 hours use if using Finessis Zero® or Finessis Corium®?

All surgical gloves are thin elastomer membranes (0,2mm only) prone to tears and perforations given its taxing physical usage such as twisting, pulling, stretching and exposure to body fluids and chemicals. Also, glove external surfaces can be contaminated by bacteria due to contact with infected surfaced or organs. Conventional gloves have intrinsic micro-porosity and are sensitive to hydration, which lead to a sharp decrease of the barrier performance.

 

For these reasons, surgical gloves must be changed regularly, at least every 60-120minutes. They also must be changed in case a visible damage is noticed, or at each time the operating procedure is requiring an aseptic barrier.

 

Flexylon™ based materials such as Finessis Zero®, Corium® or Aegis® are not sensitive to hydration and therefore it is anticipated that the glove would better behave during time-use. However, the Finessis® gloves will be damaged as any other gloves by abrasion or micro-puncture and therefore it is recommended to follow the same guidelines about frequency of changes than with any other surgical gloves.