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Gammex Latex Ortho

by Ansell Healthcare Europe NV

Ref 330065085 8.5, 20686575 Size 7.5

Active European Union. Also listed in GUDID (US).

CE MDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, GUDID, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number5414566ELOGLO330578TZ Basic UDI-DI Date4 Mar 2023RegisteredStatusActive
United StatesGUDID listing GUDID Number15414566651859 UDI-DI Date10 Feb 2022ListedStatusListed GUDID: in commercial distribution

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.

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States GUDID listing Listed

Specification

EUDAMED · GUDID

Trade Name
Gammex Latex Ortho EUDAMED
GAMMEX Non-Latex PI Ortho EUDAMED
Gammex GUDID
Generic Name
Polyisoprene surgical glove, non-powdered, non-antimicrobial
Device Name
Non-Powdered Latex Surgical Gloves
Polyisoprene Surgical Gloves
Model / Ref / Catalog
330065085 8.5 EUDAMED
20686575 Size 7.5 EUDAMED
20686575 GUDID
Primary DI / UDI-DI
15414566651859, 00884792386548
Basic UDI-DI
5414566ELOGLO330578TZ, 5414566GNLPIORT20686NG
FDA Product Code
KGO
EMDN Code
T01010102, T01010203
GMDN Term
Polyisoprene surgical glove, non-powdered, non-antimicrobial
Device Class
Class IIa EUDAMED
Class I GUDID
Regulation Number
878.4460
EU market of registration
Belgium
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 3 fields differ

FieldEUDAMEDGUDID
Model / ReferenceEUDAMED
330065085 8.5
20686575 Size 7.5
GUDID
20686575
Device ClassEUDAMED
Class IIa
GUDID
Class I
Contains LatexEUDAMED
Yes
No
GUDID
No

Manufacturer details

EUDAMED SRN
BE-MF-000000691

Other devices from Ansell Healthcare Europe NV

See all devices from Ansell Healthcare Europe NV →

Properties

  • Sterile
  • Single Use
  • Contains Latex YesEUDAMEDNoEUDAMEDGUDID
  • Over-the-Counter
  • Lot / Batch Number
  • Expiration Date
  • Manufacturing Date

Other properties (17)

  • Implantable: No
  • Reusable: 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