MEDICAL MASK, CLASS I, TYPE IIR with three layers

PRICES BY VOLUME

Payment in lei at the BNR exchange rate, plus VAT.

PRODUCT DESCRIPTION

Product name: FACIAL MASK FOR MEDICAL USE, CLASS I, TYPE IIR
Model Code: MFMT1-MM001
Manufacturer: S.C. MAREMOD S.A.
Raw material: Non-woven material, Polypropylene, 25g / m².
Dimensions (LxW): 17.5cm x 9.5cm
Bacteria filtration efficiency: BFE ≥ 98% (according to tests performed at an EU accredited laboratory in Italy, BFE = 99.8%)
Disposable product.

Certification:

Facial mask for medical use, class I, type IIR, for medical and non-medical personnel is used to reduce the risk of spreading infectious agents (viruses, bacteria or fungi) in epidemic and pandemic situations.

It is a good prevention medium in spreading viruses: SARS, COV 2, COVID 19, etc.

Surgical mask, facial for medical use, class I, type IIR, is a medical device made of 3 layers:

• Outer layer: non-woven synthetic material, polypropylene, 25gr / m², is waterproof with hydrophobic role, blue color.
• Middle layer: synthetic material, made of meltblown polypropylene, 25gr / m2, is an effective filtering barrier against infectious agents, which are transmitted by air, with Bacteria filtration efficiency: BFE = 99.8%, white color.
• The inner layer: non-woven synthetic material, polypropylene, 25gr / m², has the role of absorbing moisture from the wearer’s breath, white color.
• Other materials: flexible nose strap and elastic at the ears.
  The flexible nose flange is fixed to the top of the mask through a channel and has the quality of being shaped according to the shape of the wearer’s nasal bridge.
  The elastic grip behind the ear of the mask is fixed to the mask with the help of the ultrasound system of the automatic mask product machine.
• In the middle of the masks were projected three folds of depth 1 cm, which gives lightness to the mask and the possibility to be adapted to the different sizes of the faces of various wearers, not being necessary to create a range of sizes for this product.

Polypropylene fiber from which is made facial mask for medical use, class I, type IIR, does not present risks to the health of the wearer, does not cause skin irritation and in foreseeable conditions of normal use, does not release substances known as toxic, carcinogenic, allergenic human body. The non-woven polypropylene material, from which the facial mask for medical use is made, does not emit unpleasant odors and has a clean appearance, with a smooth, uniform surface.

Legislation

In accordance with:

• Directive 93/42 / EEC on medical devices
• Regulation (EU) 745/2017

STANDARDS AND CERTIFICATIONS

• SR EN 14683 + AC: 2019
• ISO 13485; ISO 9001; ISO 14001
• ANMDMR Medical Devices Registration Certificate

Technical and performance characteristics

Facial masks for medical use, class I, type IIR, are produced on an automatic product line facial masks for medical use, with a modern technology of the latest generation, which helps the intelligent operation of the equipment.

The automatic line for making facial masks for medical use, class I, type IIR, consists of: support for rollers, preforming line for facial masks for medical use and their ultrasonic gluing with automatic introduction of the nose flange, transfer table to the 2 lines to be applied and welded by automatic ultrasonic thermolipping of the elastic for the ears.

The level of effectiveness offered by this facial mask for medical use, class I, type IIR, is given by a series of factors that were taken into account during the design process of surgical masks:

• to have the correct size to cover the nose, mouth and chin and to ensure an adequate tightness towards the ambient atmosphere at the level of the wearer’s face.
• with the help of the fastening and fixing system, respectively of the nasal flange and of the two elastic loops, the facial mask for medical use, to be able to be correctly positioned on the user’s face and to ensure the maintenance in this position for the entire foreseeable use, taking into account the environmental conditions and the movements and positions of the user during his activity.
• not to present rough surfaces. Ultrasonic bonding of the three layers between them and the two elastic loops, fixing the nasal flange in a crease created at the top of the mask, not to create rough or hard areas, which will irritate or hurt the user.
• to have the adjustment system in the nose area, (nasal flange) designed so that the facial mask can be applied on the face and easily removed by the user. The nasal flange should be flexible, but also solid enough to allow the mask to remain firm on the figure throughout use and also to improve the fit of the flange, according to the contour of the nose.
• not to obscure the wearer’s field of vision
• to have the corresponding length of the two elastic loops, so as to ensure the correct fixing of the mask, as close as possible to the wearer’s face, but also the comfort during wearing, avoiding injury, irritation of the ear or face area.
• to offer the user a level of comfort in accordance with the level of protection against the existing danger, with the environmental conditions, with the level of activity of the user, as well as with the expected duration of use of the mask.
• the inspired air to enter the filter mask and to reach directly in the area of ​​the nose and mouth through all the layers that make up the mask, and the exhaled air to be evacuated directly into the atmosphere through the filter materials.

Also, the efficiency of filtering the facial mask for medical use is obtained due to the superior quality of the material, BFU ≥ 99, from which the middle layer is made, which represents the barrier to prevent the penetration of viruses.

PACKING

• 50 medical masks in cardboard boxes measuring 19x10x10 cm
• 60 small boxes (50 pieces of masks each), are placed in a larger cardboard box, resistant to transport, size: 58×40.5×50.5cm. Each large box will contain 3000 medical masks

ACCREDITATIONS

DATA SHEET