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Gloves (Nitrile gloves, Latex gloves, PE gloves, TPE gloves, Vinyl gloves/PVC gloves, Veterinary gloves)

by One Top Protective Products Co., Ltd.

Ref Nitrile gloves 8901- SModel Nitrile gloves 8901-S/M/L/XL/XXL Latex gloves 9901-S/M/L/XL/XXL PE gloves 2906-S/M/L/XL/XXL TPE gloves 2907-S/M/L/XL/XXL Vinyl gloves/PVC gloves 7901-S/M/L/XL/XXL Veterinary gloves 2903-S/M/L/XL/XXL

Active European Union

CE MDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

Not applicable

No FDA record for this device

Documents

None, self-declared

Class I: no certifier involved

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number697867649G01WN Basic UDI-DI 06978676491405UDI-DIDate11 Jun 2025RegisteredStatusActive

Certificates

0 certificates · EUDAMED

No certifier certificate is listed. Devices of this class are self-declared by the manufacturer.

Coverage

1 jurisdiction

SwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

European Union — CE/MDR Active

Specification

EUDAMED

Device Name
Gloves (Nitrile gloves, Latex gloves, PE gloves, TPE gloves, Vinyl gloves/PVC gloves, Veterinary gloves)
Model / Reference
Nitrile gloves 8901-S/M/L/XL/XXL Latex gloves 9901-S/M/L/XL/XXL PE gloves 2906-S/M/L/XL/XXL TPE gloves 2907-S/M/L/XL/XXL Vinyl gloves/PVC gloves 7901-S/M/L/XL/XXL Veterinary gloves 2903-S/M/L/XL/XXL, Nitrile gloves 8901- S
Primary DI / UDI-DI
06978676491405
Basic UDI-DI
697867649G01WN
EMDN Code
T0199 Gloves - other
Device Class
Class I
EU market of registration
Austria

Manufacturer details

EUDAMED SRN
CN-MF-000023063
Authorised representative
SUNGO Europe B.V. NL-AR-000000247

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Properties

Other properties (13)

  • Sterile: No
  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • CMR Substance: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Endocrine Disruptor: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No