Medical devices

Manufacturing of medical devices and cotton products
PRODUCTS

Surgical non-sterile mask - three-layered

Surgical masks are intended for use on the face (over the nose and mouth) and serve as a physical barrier to fluids and larger particles. They are used to prevent the transmission of infectious agents from healthcare personnel to patients during medical procedures, as well as the transmission of infectious agents from the mouths and noses of asymptomatic carriers of diseases or patients with clinical symptoms to the healthy population.

Primarily, they are used for medical purposes during surgical procedures to protect the wearer from splashes of potentially contaminated particles and fluids. Likewise, they may be designated for emergency situations such as epidemics and pandemics, aimed at reducing the risk of spreading infections. The masks are three-layered with elastic ear loops, single-colored, universal size, measuring 175 mm x 95 mm, for single use. We manufacture Type IIR masks. The product meets the requirements of the EN 14683 standard.

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Composition of a surgical mask

Non-woven spunbond polypropylene 20-25 g/m². It consists of a lower layer 200 mm wide and an upper layer 185 mm wide. Non-woven melt-blown spunbond polypropylene 20-25 g/m². It includes a middle layer that serves as a filter, 185 mm wide. The plasticized wire is made of aluminum wire encased in a plastic coating. It is 100 mm long and 2 mm wide. It is located between the layers at the top part above the nose. The ear strap is made of wrapped lycra (polyester fibers) with high elasticity. It is located at both ends of the mask and is 150 - 200 mm long in its unstretched state.

20-25 g/m2

20 g

filter width

0 mm

wire length

0 mm

earband

150 mm
PRODUCTS

Surgical non-sterile cap

of non-woven material

Surgical non-sterile caps are intended to prevent the transmission of infectious agents during invasive surgical procedures between patients and clinical staff. They contribute to the clinical condition and safety of patients as well as the safety and health of users. They are used to reduce the spread of infectious agents to surgical wounds and from patients, helping to prevent postoperative wound infections. The caps are for single use, universal size, with dimensions of 500 mm.
Colors – white, green, blue. 
Surgical, non-sterile caps are packaged 100/1 in PE bags and boxes of 100 pieces (Transport packaging: 10 bags of 100 pieces).

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Surgical non-sterile gown

of non-woven material

Surgical non-sterile gowns are intended to prevent the transmission of infectious agents during invasive surgical procedures between patients and clinical staff. They contribute to the clinical condition and safety of patients, as well as the safety and health of the users. They are used to reduce the spread of infectious agents to surgical wounds and from patients, helping to prevent postoperative wound infections. The gowns are for single use, universal size, measuring 110×116 cm.
Colors – white, green, blue. 
Surgical, non-sterile gowns are packaged 10/1 in PE bags or boxes of 10 pieces.
(Transport packaging: 10 bags of 10 pieces.)

PRODUCTS

Surgical non-sterile shoe covers

of non-woven material

Surgical non-sterile shoe covers are intended to prevent the transmission of infectious agents during invasive surgical procedures between patients and clinical staff. They contribute to the clinical condition and safety of patients, as well as to the safety and health of users. They are used to reduce the spread of infectious agents to surgical wounds and from patients, helping to prevent postoperative wound infections. The drapes are for single use, universal size, measuring 380×170 mm.
Colors – white, green, blue. 
Surgical, non-sterile drapes are packaged in PE bags or boxes of 100 pieces (Transport packaging: 10 bags or boxes of 100 pieces each).

Production according to modern global and European standards

ISO 9001:2015

Our company has aligned its operations with the essential requirements of European directives and regulations.

ISO 13485:2016

In this way, we have ensured that the product we bring to market is biocompatible and safe for the end user.

EC Certificate

Niva also holds MDD-010 and MDD-145 certificates.

IFS HPC V3

Certificate of compliance with international product safety and quality standards.

PRODUCTS

Medical cotton wool

Medical cotton wool has a wide range of applications in healthcare, for cosmetic purposes, and for intimate hygiene. It is made of bleached cotton and is soft, hydrophilic, clean, and chemically neutral. It is rolled with a layer of paper.

It is used as a non-sterile medical device for single-use, external application, Class I. It is packed in bags and then placed in cardboard boxes.

Medical cotton wool is available in the following variants: 50 g, 80 g, 100 g, 150 g, 160 g, 200 g, 250 g, 300 g, 350 g, 400 g, 450 g, 500 g, 550 g, 600 g, 650 g, 700 g, 750 g, 800 g, 850 g, 900 g, 950 g, and 1000 g.

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Sterile cotton gauze

Made from bleached cotton gauze. Folded in layers with dimensions: ·¼ m (25 cm x 80 cm) densities of 17 and 20 threads/cm2; ·½ m (50 cm x 80 cm) densities of 17 and 20 threads/cm2; ·1 m (100 cm x 80 cm) densities of 17 and 20 threads/cm2. Used in healthcare. As a sterile product, it can be applied directly to the wound. Individually packaged in paper and then grouped in sets of 10 in bags and placed in cardboard boxes. Catalog number: Sterile cotton gauze 1/4m; Sterile cotton gauze 1/2m; Sterile cotton gauze 1m. Sterile cotton gauze is used as a sterile medical device, Class Is, for single-use external application.
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Sterile gauze compress

It is made of bleached cotton gauze, with densities of 17 threads/cm2 and 20 threads/cm2. They are folded into 8, 12, or 16 layers, in dimensions of 5 cm × 5 cm, 7.5 cm × 7.5 cm, 10 cm × 10 cm, 8 cm × 5 cm, 8 cm × 15 cm, and 20 cm × 10 cm. Sterile gauze compresses are used in healthcare for wound covering. They are used as sterile medical devices for single use, Class Is.
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NIVA Baby sterile compresses

Niva Baby sterile compresses are made from high-quality bleached cotton gauze, layered in 16 layers, making them ideal for use in healthcare facilities and home care. They are available in the size of 5 cm × 5 cm, 10 pieces per box, with a density of 17 threads/cm2, perfectly suited for wound treatment. As a sterile product, they can be placed directly on the wound, providing safety and hygiene. Each compress is individually wrapped in a sachet to preserve sterility. Niva Baby sterile compresses guarantee quality and reliability for the most sensitive care.
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Your safety, our mission

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Calico bend

Kaliko gauze with woven edges is made by weaving 100% raw cotton yarn, with a weaving density of 17 and 24 threads/cm2. It is woven in widths of 5 cm, 6 cm, 8 cm, 10 cm, 12 cm, and 15 cm, rolled in 5 and 10 m lengths. It is intended for external use during bandaging. As a non-sterile product, it should not be placed directly on a wound. It is individually packaged in cellophane, with 10 pieces bulk-packed in foil, and then placed in cardboard boxes.
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Pamučna gaza

Cotton gauze is made of bleached cotton woven in plain weave, with densities of 13, 17, and 20 threads/cm2. It has a wide range of applications in healthcare, industry, and household use. It is intended for wound compression over sterile gauze, compresses, or the first bandage, to enhance compression in case of bleeding. It must not be applied directly to the wound because it is a non-sterile product, but only over sterile gauze. It is used as a medical device for single-use. It is packed in PE bags and then placed in transport boxes. Dimensions: 80 cm × 10 m, 80 cm × 100 m, 90 cm × 100 m, 90 cm × 10 m, 100 cm × 90 m, 100 cm × 10 m.
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Non-sterile gauze compresses

Non-sterile gauze compresses are made of bleached cotton gauze woven in plain weave, with densities of 17 and 20 threads/cm2, in 8, 12, and 16 layers. Non-sterile gauze compresses are intended, after sterilization, for covering wounds following surgical procedures, burns, and wounds with significant bleeding. Additionally, they can be used as a padding for immobilization when there is no skin injury, and for covering larger wounds over sterile gauze to absorb exudate. They are used in healthcare as a medical device for single-use external application. They are packed in boxes and then placed in transport cartons. Dimensions: 5 cm × 5 cm, 7.5 cm × 7.5 cm, 10 cm × 10 cm, 15 cm × 7 cm, 20 cm × 10 cm.
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Your safety, our mission

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Elastic bandage

Elastic bandage is a woven product made of raw cotton yarn and bare rubber threads. It is used in healthcare and household settings for joint fixation and compression of superficial veins. The elastic bandage is a medical device intended for multiple-use applications. Dimensions: 8 cm × 5 m, 10 cm × 5 m, 12 cm × 5 m, 15 cm × 5 m; 5 cm × 10 m, 10 cm × 10 m, 12 cm × 10 m, 15 cm × 10 m.
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Quality in tradition

PRODUCTS

Medical compression stockings

Medical compression stockings are made of elastomer, polyester, and polyamide. As a strong support, they are used for the treatment and prevention of complications associated with varicose veins. The level of compression helps to prevent swelling and feelings of heaviness, and slows down the progression of varicose syndrome. The extra knee-high is used for stabilizing the knee after injuries to the knee region or in cases of chronic ligament strain. They are packaged in individual boxes and then in bulk. They are available in six sizes. Types of medical socks: MG medical rubber ankle sock, MG medical rubber calf sock, MG medical rubber knee sock, MG medical rubber thigh sock, MG medical rubber full-length sock.
They are used as medical devices for multiple-use applications.

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Paper wool

Paper cotton wool is made of 100% bleached cellulose, white in color, and has good absorbent properties.
It has a wide range of applications in healthcare, as well as for cosmetic purposes to enhance hygiene. It is suitable for cleaning all surfaces in medicine and other areas.

It is used as a non-sterile medical device for single-use applications. It must not be applied directly to a wound. It is used over sterile gauze (for absorbing wound exudate), for padding splints before application to immobilized areas, and for wiping larger areas of the body where there is no skin injury.

It is packed in PE bags and then placed in transport cartons.

Paper cotton wool is available in the following dimensions:
Paper width: 30 cm and 40 cm
Weights: 1000 g, 5 kg

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Paper container (kidney-shaped)

Usage: in medicine, home care, nursing homes, veterinary medicine, cosmetics, etc.
• Dimensions: 252 x 150 x 46 mm

Technical specifications:
• Material: molded paper pulp
• Resistance: 36 hours to water, 4 hours to organic liquids
• Maximum capacity: approximately 750 ml
• Recycling: biodegradable and compostable