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GAMMEX Non-Latex PI Ortho

by Ansell Healthcare Europe NV 6 variants

Ref 20686590 Size 9

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 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number5414566GNLPIORT20686NG Basic UDI-DI 00884792386579UDI-DIDate14 Feb 2024RegisteredStatusActive EUDAMED: not on the EU market
United StatesGUDID listing GUDID Number00884792386579 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  • Withdrawn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 Non-Latex PI Ortho EUDAMED
Gammex GUDID
Generic Name
Polyisoprene surgical glove, non-powdered, non-antimicrobial
Device Name
Polyisoprene Surgical Gloves
Model / Ref / Catalog
20686590 Size 9 EUDAMED
20686590 GUDID
Primary DI / UDI-DI
00884792386579
Basic UDI-DI
5414566GNLPIORT20686NG
FDA Product Code
KGO
EMDN Code
T01010203 Polyisopren surgical gloves
GMDN Term
Polyisoprene surgical glove, non-powdered, non-antimicrobial
Device Class
Class IIa EUDAMED
Class I GUDID
Regulation Number
878.4460
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / ReferenceEUDAMED
20686590 Size 9
GUDID
20686590
Device ClassEUDAMED
Class IIa
GUDID
Class I

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

Other properties (18)

  • 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