CHIRURGICAL MASKS APPROVED BY THE ITALIAN “ISTITUTO SUPERIORE SANITA (Government High Institute of Healthcare) – LASERPIN “MASK-LASE 1”

Masks for wholesale distribution in compliance with the UNI EN ISO 14683:2019 laws&regulations

DISPOSABLE APPROVED SURGICAL MASKS

Through the experience gained with designing, assembling and manufacturing customised and industrial machines and units, Laserpin started a production of chirurgical face masks approved for the health sector including, but not limited to, public administration and government realities, such as hospitals, and companies using this type of mask.

Certified “Made in Italy” masks

LaserPin offers an Italian manufactured item, carefully produced and always in compliance with current regulations to guarantee high standards quality.

The staff is equipped with all the necessary safety devices, and the environment is periodically sanitized, just as the equipment used.

Thanks to company choice of high-quality materials, our 100% “Made in Italy” masks feel extremely soft and comfortable while wearing them.

Every material layer or final product is trackable, as a result of a diligent production management.

Our chirurgical masks are manufactured and packaged in our HQ, in the city of fashion Milan, sited in the north region of Italy, Lombardy.

All certifications can be downloaded from this website.

LABEL

Below you can find the specifications also reported on each mask package, as required by any given regulations:

  • Manufacturer: Laserpin s.r.l.;
  • Mask-lase1;
  • Non-sterile;
  • Compliant to UNI EN ISO 14683:2019;
  • Type: Type I;
  • Shelf life: 5 years;
  • Single-use;

Made pursuant to art. 15 paragraph 2 of the D.L. March 17, 2020, converted into law April 24, 2020 n.27

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Packaging Terms

Packages including 10 masks. Polypropylene envelope.

All tests made following European laws&regulations in addition to Italian strict requirements

Tests carried out standards UNI EN 14683:2019 and UNI EN ISO 10993-1:2010

Here the tests performed for each standard.

Technical Standard UNI EN 14683:2019 “Face masks for medical use – Requirements and test methods”:

  • Bacterial Filtration Efficiency (BFE) (in %);
  • Breathability (in Pa/cm2);
  • Microbial Cleaning (Bioburden).

Report of biocompatibility tests on tissue (tissue without any type of physical, chemical or any other kind of treatment) according to the technical standard UNI EN ISO 10993-1: 2010 “Biological evaluation of medical devices-Part 1: Evaluation and tests within a risk management process”:

  • Cytotoxicity;
  • Skin irritation – biological evaluation report drawn up on a bibliographic basis;
  • Allergic sensitization.

APPROVED CERTIFICATIONS FOR SURGICAL MASKS

https://www.laserpin.com/wp-admin/post.php?post=1479&action=edit&lang=it#

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