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Bergamot Cobalt Blue Nitrile Powder Free Examination Glove

by Bergamot Sdn Bhd 5 variants

Ref X2230CB (M)Model X Series

Active European Union and United States

CE MDR 510(k)

Valid until

Not listed

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

None found

in data synced 24 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K223444↗

FDA record

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, FDA 510(k), synced 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k) 510(k) NumberK223444 Date6 Feb 2023IssuedStatusActive
European UnionCE/MDR EUDAMED Number9555904NPFMA Basic UDI-DI 09555904304521UDI-DIDate19 Nov 2021RegisteredStatusActive

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 24 Oct 2026.

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • United States FDA 510(k) Active
  • European Union CE/MDR Active

Specification

EUDAMED · 510(k)

Device Name
Nitrile Powder Free Examination Glove
Model / Reference
X Series, X2230CB (M)
Primary DI / UDI-DI
09555904304521
Basic UDI-DI
9555904NPFMA
EMDN Code
T01020204 Nitrile examination / treatment gloves
Device Class
Class I
EU market of registration
Germany

Manufacturer details

EUDAMED SRN
MY-MF-000004005
Authorised representative
ASAP Innovations Ltd. IE-AR-000002548

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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