Skip to content

Gcare Disposable Vinyl Glove, Clear Colour, Powder Free, M 4.5g, Size XL

by Zibo Blue Sail Innovation Co., Ltd.

Ref 479.801Model VEM0101

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 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing GUDID Number06975219206540 UDI-DI Date26 May 2026ListedStatusListed GUDID: in commercial distribution
European UnionCE/MDR EUDAMED Number697521920EM0101147176BL Basic UDI-DI 06975219206540UDI-DIDate1 Sep 2022RegisteredStatusActive

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  • Withdrawn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
Gcare Disposable Vinyl Glove,Clear Colour,Powder Free,M 4.5g,Size XL EUDAMED
Gcare GUDID
Generic Name
Vinyl examination/treatment glove, non-powdered
Device Name
Disposable Vinyl Examination Gloves, Powder Free
Model / Reference
VEM0101, 479.801
Primary DI / UDI-DI
06975219206540
Basic UDI-DI
697521920EM0101147176BL
Direct Marketing DI
06975219206540
FDA Product Code
LYZ
EMDN Code
T01020201 Vinyl examination / treatment gloves
GMDN Term
Vinyl examination/treatment glove, non-powdered
Device Class
Class I
Regulation Number
880.6250
EU market of registration
Belgium
GUDID distribution status
In Commercial Distribution
MRI Safety
MR Safe

Manufacturer details

EUDAMED SRN
CN-MF-000023103
Authorised representative
Lotus NL B.V. NL-AR-000000121

Other devices from Zibo Blue Sail Innovation Co., Ltd.

See all devices from Zibo Blue Sail Innovation Co., Ltd. →

Properties

  • Single Use
  • Over-the-Counter
  • Lot / Batch Number
  • Serial Number
  • 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
  • Expiration Date: No