Made in Italy
The production line, the warehouse, the operational headquarters and the test laboratories are located in the province of Vicenza.
Made from Italian machinery
The entire production line was designed and built by Smac Srl, a company from Camisano Vicentino, specialized in industrial automation.
Produce with Italian materials
Composed of 3 layers of non-woven fabric, Latex Free round elastics and ergonomic nose pad to make the mask adhere firmly to the face.
All materials are made by Italian companies.
Why 100 %
ITALIAN?
To maintain the integrity and hygiene of the single mask, we pack them individually or in flow packs of 10 pieces.
Safer
Date of production, traceability and genealogy of materials for greater product reliability.
Traceable
DISPOSABLE SURGICAL MASK - TYPE II
TYPE II masks are primarily intended for use by healthcare professionals in the operating room or other medical activities with similar requirements.
DISPOSABLE
Warning: The "Prima" surgical mask is a disposable device and is therefore not washable and reusable.
SANITIZED PRODUCT
For greater safety and quality, in the production environment
we sanitize the machinery and everything that comes into contact with the mask.
CE CERTIFIED
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.
HEALTH MEDICAL DEVICE
The Prima surgical mask is registered in the database of the Ministry of Health as a medical device with code RDM: 1995775 and CND: T020699
LATEX FREE
The ear bands are latex-free and thanks to their high elastic property, they give greater comfort when wearing the mask.
Physical
properties
Physical
properties
Prima
&
Piuma
Prima
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 device according to EN 14683: 2019
You can find it in 3 different colors: White, Blue and Blue.
Piuma Comfort
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 (cfu / g) ≤ 30.
For this reason it is classified as a TYPE II device according to EN 14683: 2019
Color: White
ISO 9001 : 2015
Quality management system for the methods of managing purchasing processes, manufacturing, quality control, management of non-conformities.
UNI EN 14683 : 2019
Facial masks for medical use - Requirements and test methods.
UNI EN ISO 10993-1 : 2010
Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process.
UNI CEI EN ISO 15223-1 : 2017
Medical devices - Symbols for use on medical device labels, labeling and information to be provided.
