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Organization name
UDI-DI code
Reference / catalog number

Latex examination gloves, DONA… — Class I MDR

MD Atlas
VULKAN - Medical, a.s.

EUDAMED last updated this device on May 6, 2026

Latex examination gloves, DONA Sensitive, powdered

859420032LAT3EP

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: VULKAN - Medical, a.s.
UDI-DI code: 08594200320713
Reference / catalog number: 9015-XS

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Manufacturer information

Organization name: VULKAN - Medical, a.s.
SRN: CZ-MF-000016349
Manufacturer status: Active

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Certificates

No certificates registered for this manufacturer.

No certificate references this Basic UDI-DI, because: • It does not require a certificate, or • It only requires a certificate without a Basic UDI-DI reference (e.g. a QMS certificate), or • The required certificate(s) referencing this Basic UDI-DI have not been registered yet.

Critical warnings

2 warnings recorded — scroll inside the panel to see all entries.

CW009
EUDAMED did not publish a description for this code.
CW999
Any serious incident that has occurred in relation to the device should be reported to the manufacturer and the competent authority of the Member State. This product contains natural rubber latex which may cause allergic reactions. Don the gloves only on clean, dry hands. For prolonged or demanding procedures, replace them more frequently. Certain components or auxiliary materials used in the manufacturing process may elicit allergic reactions in sensitive individuals. Should any irritation occur, discontinue use and seek medical advice.

Market distribution

Primary placement in Czechia; available across 2 countries total.

Country	On market since	Until
CzechiaPrimary placement		Still on market
Slovakia		Still on market

Device identification

Trade name: Latex examination gloves, DONA Sensitive, powdered
UDI-DI code: 08594200320713
Basic UDI-DI: 859420032LAT3EP
Reference / catalog number: 9015-XS
Issuing entity: GS1

Classification

Risk category: Class I
Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Status: On the market

Device details

Quantity: 100
Additional product description: —
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: XS / EXTRA MALÉ / EXTRA SMALL

EMDN nomenclature code(s)

T010201LATEX EXAMINATION / TREATMENT GLOVES

Compliance flags

Safety

Sterile

Single use

Contains latex

Reprocessed single-use

Direct marking

Substances

CMR substance

Endocrine disruptor

Regulatory

Annex XVI applicable

Sterilization

Lifecycle

New device

UDI-PI traceability

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