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HS Glove Powder Free Nitrile Examination Glove

by Aimax Healthcare Sdn. Bhd. 16 variants

Ref A035BLK240F (S)Model A035BLK240F

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, self-declared

Class I: no certifier involved

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
United StatesGUDID listing GUDID Number09551012690075 UDI-DI Date8 May 2023ListedStatusListed GUDID: in commercial distribution
European UnionCE/MDR EUDAMED Number955101269A035BLK240FSN Basic UDI-DI 09551012690075UDI-DIDate4 Apr 2023RegisteredStatusActive

Certificates

0 certificates · EUDAMED

No certifier certificate is listed. Devices of this class are self-declared by the manufacturer.

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  • Withdrawn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
HS Glove Powder Free Nitrile Examination Glove EUDAMED
HS Glove GUDID
Generic Name
Nitrile examination/treatment glove, non-powdered, non-antimicrobial
Model / Reference
A035BLK240F, A035BLK240F (S)
Primary DI / UDI-DI
09551012690075
Basic UDI-DI
955101269A035BLK240FSN
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
EU market of registration
Spain
GUDID distribution status
In Commercial Distribution

Manufacturer details

EUDAMED SRN
MY-MF-000028785
Authorised representative
Jumapanilo S.L. ES-AR-000004849

Other devices from Aimax Healthcare Sdn. Bhd.

See all devices from Aimax Healthcare Sdn. Bhd. →

Properties

  • Single Use
  • Lot / Batch Number
  • Expiration Date

Other properties (21)

  • 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
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No
  • Manufacturing Date: No