Skip to content

JR Medic Extra Thick Nitrile Exam Powder-free Gloves LGE

by JR Engineering & Medical Technologies (M) Sdn Bhd

Ref JRETNIEXAMLGEModel JRETNIEXAMXSML

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 23 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K222348↗

+1 more

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, FDA 510(k), synced 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number506101679JR300NEETF7 Basic UDI-DI 45061016790203UDI-DIDate17 Jul 2023RegisteredStatusActive
United StatesFDA 510(k) 510(k) NumberK222348 Date27 Oct 2022IssuedStatusActive

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 23 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  • Withdrawn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
JR Medic Extra Thick Nitrile Exam Powder-free Gloves X-SML
Model / Reference
JRETNIEXAMXSML, JRETNIEXAMLGE
Primary DI / UDI-DI
45061016790203
Basic UDI-DI
506101679JR300NEETF7
EMDN Code
T01020204 Nitrile examination / treatment gloves
Device Class
Class I
EU market of registration
Ireland

Manufacturer details

EUDAMED SRN
MY-MF-000035051
Authorised representative
Vega Product Solutions BV NL-AR-000035612

Other devices from JR Engineering & Medical Technologies (M) Sdn Bhd

See all devices from JR Engineering & Medical Technologies (M) Sdn Bhd →

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