CHIRURGICAL MASKS
APPROVED BY THE SUPERIOR INSTITUTE OF HEALTH
Masks that comply with the UNI EN ISO 14683:2019 standard
CHIRURGICAL MASKS
LaserPin, using the experience gained in manufacturing and management of processing units, has also started production of approved surgical masks for public administrations, private companies, communities and alike.
MADE IN ITALY CERTIFIED MASKS
LaserPin offers an Italian-made product, carefully manufactured to comply with current regulations and guarantee high quality protection devices.
The entire production and enveloping process is mainly automated. Furthermore, it is designed to guarantee the necessary requirements to ensure a safe product with high quality standards.
The staff in charge of reel loading is equipped with all the devices required for the safe production of masks. In addition, the rooms in which work is carried out are sanitized on a regular basis, as the equipment is used.
Careful tracking of raw materials and production, packing and storage processes accurate in every step allows LaserPin to deliver a high-quality product, certified according to current regulations. The certification can be downloaded from this website.
Thanks to their special workmanship, these masks, entirely made in Italy, possess a cashmere touch feature, which ensures great comfort for the face.
The protective devices are manufactured and packaged at LaserPin factory in Lombardy, guaranteeing maximum control over production.
CERTIFICATIONS OF OUR APPROVED SURGICAL MASKS
LABELS
Below are the specifications also found on the labels of the masks we produce as required by current regulations.
- Manufacturer: LaserPin s.r.l.
- Mask-lase 1
- Non-sterile
- Conforms to UNI EN ISO 14683:2019
- Type: Type I
- Expiry date: 5 years
- Single-use
Made in accordance with Art. 15 paragraph 2 of Decree-Law 17 March 2020, converted into Law 24 April 2020 no. 27 (Italian regulations).
PACKAGING TERMS
The primary packaging includes 10 masks wrapped in polypropylene film.
TESTS CARRIED OUT IN ACCORDANCE WITH STANDARDS UNI EN 14683:2019 and UNI EN ISO 10993-1:2010
Tests performed for each regulation. 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 Cleanliness (Bioburden).
Report of biocompatibility tests on tissue (tissue without any 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 testing within a risk management process”:
- Cytotoxicity;
- Skin irritation – literature-based biological assessment report;
- Allergic susceptibility.
