The first 100% Italian surgical mask
Why 100 % ITALIAN?
Produce with Italian materials
All materials are made by Italian companies.
Made from Italian machinery
The entire production line was designed and built by Smac Srl, a company from Camisano Vicentino, specialized in industrial automation.
Made in Italy
Prima IIR Physical properties:
TYPE II R
TYPE II R masks are primarily intended for use by healthcare professionals in the operating room or other medical activities with similar requirements.
For greater safety and quality, in the production environment we sanitize the machinery and everything that comes into contact with the mask.
Warning: The “Prima” surgical mask is a disposable device and is therefore not washable and reusable.
Our mask was built and subsequently tested, respecting the following directives and technical standards:
– Dir. 93/42 / CEE, D.L. 24/02/97 n.46, D.L. 25/02/98 N.95 Council Directive concerning medical devices – Implementation of Directive 93/42 / EEC concerning medical devices. Amendments to the Legislative Decree 24 February 1997 n. 46
– UNI EN 14683: 2019, UNI EN ISO 10993-1: 2010, UNI EN 14971: 2012, UNI EN 1041: 2009,
UNI EN ISO 15223-1: 2012 And it is therefore compliant with the directives and regulations in force.
The Prima surgical mask is registered in the database of the Ministry of Health as a medical device with code:
RDM: 2068934 and CND: T020601
The ear bands are latex-free and thanks to their high elastic property, they give greater comfort when wearing the mask.
To maintain the integrity and hygiene of the single mask, we pack them individually or in flow packs of 10 pieces.
Date of production, traceability and genealogy of materials for greater product reliability.
Prima & Piuma
Prima is the mask that started the Sanintek project.
It guarantees a Bacterial filtration level (BFE)> 98%, offers a reduced resistance to breathing with a Pressure Drop (PD) <40% and a Microbial Cleanliness (ufc / g) <30.
For this reason it is classified as a TYPE II R device according to EN 14683: 2019
Color: Blue, White, Light Blue and Black
Piuma Comfort takes its name from the SMS fabric used, which makes it much more comfortable and delicate on the skin of the face.
It guarantees a Bacterial Filtration level (BFE)> 99%, offers a reduced resistance to breathing with a Pressure Drop (PD) <36% and a Microbial Cleanliness
UNI EN 14683 : 2019
Facial masks for medical use – Requirements and test methods.
UNI CEI EN ISO 15223-1 : 2017
Medical devices – Symbols for use on medical device labels, labeling and information to be provided.
UNI EN ISO 10993-1 : 2010
Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process.