Skip to content

Disposable Nitrile Gloves

by Huizhou Anboson Technology Co., Ltd. 4 variants

Ref ABC-DG01Model ABC-DG01、ABC-DG02、ABC-DG03、ABC-DG04、ABC-DG05、ABC-DG01-NI

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 25 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K230542↗

FDA record

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, FDA 510(k), synced 25 Oct 2026. What this means

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number697605518nitrileglovesSV Basic UDI-DIDate10 Feb 2025RegisteredStatusActive
United StatesFDA 510(k) 510(k) NumberK230542 Date31 May 2023IssuedStatusActive

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 25 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  • Withdrawn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
Disposable Nitrile Gloves
Disposable Latex Gloves
Model / Reference
ABC-DG01、ABC-DG02、ABC-DG03、ABC-DG04、ABC-DG05、ABC-DG01-NI, ABC-DG01
Primary DI / UDI-DI
06976055180001, 06976055180018, 16976055180022, 06976055180049, 16976055180039, 16976055180015, 06976055180032, 16976055180046
Basic UDI-DI
697605518nitrileglovesSV, 697605518LatexGlovesX8
EMDN Code
T01020204, T010201
Device Class
Class I
Market of Registration
Austria

Manufacturer details

EUDAMED SRN
CN-MF-000039003
Authorised representative
SUNGO Europe B.V. NL-AR-000000247

Other devices from Huizhou Anboson Technology Co., Ltd.

See all devices from Huizhou Anboson Technology 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