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Nitrile Examination gloves

by Schneider Medical Industries EUDAMEDGUDID

Active European Union and United States

Ref NBFK6101, NBFK6121, EN35A, NBFK81, EN45F, NBFT6001, EN35Y, EN35U, EN45FC3, EN35V, EN45FC0, NBFK6102, HD45A, NBFT6024, HD45K, NBFT60, EN45FC4, HD22K, NBFT80, EN45FD3, EN35F, NBFK71, NBFK6103, NBFK6125, NBFT6020, NBFK6120, NBFK6105, EN35P

Regulatory status

as of 27 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing GUDID Number00810112477917 UDI-DIDate22 Dec 2025ListedStatusIn distribution
European UnionCE/MDR EUDAMED Number081011247NIR01U7 Basic UDI-DIDate12 Aug 2024RegisteredStatusActive

Coverage

2 jurisdictions

United States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaSwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered
  • European Union CE/MDR Active
  • United States GUDID listing Listed

Recalls: none on record (FDA, checked 22 Oct 2026)

Certificates: none listed in EUDAMED

Specification

EUDAMED · GUDID

Trade Name
Nitrile Examination gloves EUDAMED
Schneider GUDID
Generic Name
Nitrile examination/treatment glove, non-powdered, non-antimicrobial
Model / Reference
NBFK6101, NBFK6121, EN35A, NBFK81, EN45F, NBFT6001, EN35Y, EN35U, EN45FC3, EN35V, EN45FC0, NBFK6102, HD45A, NBFT6024, HD45K, NBFT60, EN45FC4, HD22K, NBFT80, EN45FD3, EN35F, NBFK71, NBFK6103, NBFK6125, NBFT6020, NBFK6120, NBFK6105, EN35P
Primary DI / UDI-DI
00810112477917, 00810112478037, 00810112475944, 00810112474268, 00810112477207, 00810112477672, 00810112475166, 00810112476323, 00810112477214, 00810112473445, 00810112477184, 00810112477924, 00810112470086, 00810112477825, 00810112472486, 00810112477801, 00810112477221, 00810112472844, 00810112474022, 00810112477337, 00810112473209, 00810112476446, 00810112477931, 00810112478075, 00810112477788, 00810112478020, 00810112477955, 00810112472004
Basic UDI-DI
081011247NIR01U7
Direct Marketing DI
00810112477917
00810112478037
00810112475944
00810112474268
00810112477207
00810112477672
00810112475166
00810112476323
00810112477214
00810112473445
00810112477184
00810112477924
00810112470086
00810112477825
00810112472486
00810112477801
00810112477221
00810112472844
00810112474022
00810112477337
00810112473209
00810112476446
00810112477931
00810112478075
00810112477788
00810112478020
00810112477955
00810112472004
FDA Product Code
LZA
EMDN Code
T01020204 Nitrile examination / treatment gloves
GMDN Term
Nitrile examination/treatment glove, non-powdered, non-antimicrobial
Device Class
Class I
Regulation Number
880.6250
Market of Registration
Germany
Commercial Distribution
In Commercial Distribution

Manufacturer details

EUDAMED SRN
US-MF-000043641
Authorised representative
SUNGO Europe B.V. NL-AR-000000247

Other devices from Schneider Medical Industries

See all devices from Schneider Medical Industries →

Properties

  • Single Use YesGUDIDNoGUDID
  • Over-the-Counter
  • Lot / Batch Number
  • Expiration Date
  • Manufacturing Date

Other properties (19)

  • 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
  • Prescription Use: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No