UNI EN ISO 14683 | UNI EN ISO 10993

Surgical Face Mask IIR Z-UNI-1803-ZM

Description
the surgical face mask Z-UNI-1803-ZM is a Class I medical device, made in Italy, with Italian materials.
This is a single-use filtration device made of three layers of TNT high efficiency non-woven fabric soft on the skin.
Two elastic bands are fixed on the edges of the mask to allow an easily worn around the ears.
On the upper side, there is a conformable clip to adjust the mask around the nose.
The chemical composition of the filtering part is as follows: non-woven spunbond melt blown + hydrophobic spunbond white polypropylene without adding any additives.

Dimensions
Adults
Size of the folded mask is 175 +/- 5 x 92 +/- 5 mm.
The size of the mask is 175 +/- 5 x 180 +/- 5 mm.

Junior
Size of the folded mask is 145 +/- 5 x 92 +/- 5 mm.
The size of the mask is 145 +/-5 x 92 +/- 5mm.

Sterility
The Z-UNI-1803-ZM mask is NOT a sterile product.
Warnings: not suitable for people with allergies to polypropylene, latex and polyester.

Use
The mask should be worn adjusting the elastic band around the ears and trimming the nose-clip ensuring to cover the nose and mouth.

Storage
Storage at room temperatures. Protect from moisture, light and dust and other external contaminants.
The product will expire 5 years after the date of production if correctly stored in the original sales package.

Method of disposal
Dispose according to local regulations.

Made in Italy

EN 149:2001 + A1009 CE 2008 | Reg. UE 2016/42

Surgical Face Mask FFP2-NR “Riviera”

Download FFP2 Certificates

Description
RIVIERA is a disposable FFP2 NR protective halfmask and is a PPE individual protection device, produced with PP non-woven fabric and melt-blown filter material: effectively protects against various biological agents such as fine particles and dust.

STORAGE AND PRESERVATION
The halfmask must be kept in its original packaging, sealed to keep its properties intact until the time of use. During storage, transport and stowage, the environmental conditions provided by the manufacturer for the correct storage must be respected. The production date and lot number are indicated on the envelope, the expiry date is 3 years from the production date if the product is properly stored.

HOW TO WEAR IT

1. With the device still folded, grasp the centre of the fold with one hand and both rubber bands with the other hand and stretch 2 or 3 times to check the tightness.
2. Open the device, placing the facepiece under the chin and with the underwire clip over the nose.
3. Adjust the rubber bands around the ears.
4. Model the underwire nose clip on shape of the face. Before entering the work area, check the facepiece with the leak test.

LEAKTEST
Make sure the device is properly worn and sealed on the face as follows:
Cover the halfmask with both hands and exhale vigorously. If you feel that air passes through the edges and around the nostrils, place the device back on the face and tighten the nose clip. Repeat until you get the best results.

Markings – NR = Not reusable (for one shift only)

Approvals – These products meet the safety requirements of Regulation (EU) 2016/425 of the European Parliament and of the Council of 09 March 2016 on personal protective equipment and therefore bear the 2008 marking
The products meet the requirements of the standard EN 149: 2001 + A1: 2009
The EU-type examination certificate was issued by:
DolomiticertScarl-ViaVillanova, 7 / A -32013Longarone (BL) -Italy.
Notified Body n. 2008
The conformity assessment procedure was performed in accordance with Article 19 in compliance with the requirements of Annex V (module B) and Annex VII (module C2) of Regulation (EU) 2016/425.

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info@zaolimed.com

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