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Gammex PI Plus Glove-in-Glove System

by Ansell Healthcare Europe NV 8 variants

Ref 340082075 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
United StatesGUDID listing GUDID Number15414566822754 UDI-DI Date15 Jul 2024ListedStatusListed GUDID: in commercial distribution
European UnionCE/MDR EUDAMED Number5414566GPIPLGIG340088V Basic UDI-DI 15414566822754UDI-DIDate6 Mar 2023RegisteredStatusActive

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  • Withdrawn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 PI Plus Glove-in-Glove System EUDAMED
Gammex GUDID
Generic Name
Polyisoprene surgical glove, non-powdered, non-antimicrobial
Device Name
Polyisoprene Surgical Gloves
Model / Ref / Catalog
340082075 7.5 EUDAMED
340082075 GUDID
Primary DI / UDI-DI
15414566822754
Basic UDI-DI
5414566GPIPLGIG340088V
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
EU market of registration
Belgium
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / ReferenceEUDAMED
340082075 7.5
GUDID
340082075
Device ClassEUDAMED
Class IIa
GUDID
Class I

Manufacturer details

EUDAMED SRN
BE-MF-000000691

Other devices from Ansell Healthcare Europe NV

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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