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Silky Soft Gloves

by GMT International SUPER GLOVES Pte. Ltd. 10 variants

Ref Silky Soft Nitrile Examination PF Black (S)

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 Number888501870NO003HN Basic UDI-DI 08885018702304UDI-DIDate8 Apr 2026RegisteredStatusActive

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  • Withdrawn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
Nitrile Examination Gloves Powder Free
Model / Reference
Silky Soft Nitrile Examination PF Black (S)
Primary DI / UDI-DI
08885018702304
Basic UDI-DI
888501870NO003HN
EMDN Code
T01020204 Nitrile examination / treatment gloves
Device Class
Class I
EU market of registration
Greece

Manufacturer details

EUDAMED SRN
SG-MF-000022815
Authorised representative
GMT Normaxis Single Member S.A. EL-AR-000053061

Other devices from GMT International SUPER GLOVES Pte. Ltd.

See all devices from GMT International SUPER GLOVES Pte. 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