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Disposable Nitrile Examination Gloves

by Xinxiang City Rongjun Medical Apparatus Co, Ltd.

Ref Powder-Free Nitrile Examination Gloves XSModel XS/S/M/L/XL 、Powder-Free Nitrile Examination Gloves 、Powdered Nitrile Examination Gloves 、Textured Fingertips Nitrile Gloves

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 25 Oct 2026. What this means

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number697394987NitrileGloves5W Basic UDI-DIDate28 Jul 2026RegisteredStatusActive

Certificates

0 certificates · EUDAMED

No notified-body 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  • Withdrawn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
Disposable Nitrile Examination Gloves
Model / Reference
XS/S/M/L/XL 、Powder-Free Nitrile Examination Gloves 、Powdered Nitrile Examination Gloves 、Textured Fingertips Nitrile Gloves, Powder-Free Nitrile Examination Gloves XS
Primary DI / UDI-DI
06973949872806
Basic UDI-DI
697394987NitrileGloves5W
EMDN Code
T01020204 Nitrile examination / treatment gloves
Device Class
Class I
Market of Registration
Austria

Manufacturer details

EUDAMED SRN
CN-MF-000057262
Authorised representative
SUNGO Europe B.V. NL-AR-000000247

Other devices from Xinxiang City Rongjun Medical Apparatus Co.ltd

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