Skip to content

Mediskin Disposable Nitrile Examination Gloves, Blue Colour, Powder-free, Finger Textured, M size

by Zibo Blue Sail Innovation Co., Ltd.

Ref TG61Model NEM0102

Active European Union and United States

CE MDR 510(k)

Valid until

Not listed

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

None found

in data synced 25 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K021668↗

FDA record

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, FDA 510(k), synced 25 Oct 2026. What this means

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number697521920EM0102156286CH Basic UDI-DI 06975219205871UDI-DIDate1 Sep 2022RegisteredStatusActive
United StatesFDA 510(k) 510(k) NumberK021668 Date12 Aug 2002IssuedStatusActive

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.

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 25 Oct 2026.

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • United States FDA 510(k) Active
  • European Union CE/MDR Active

Specification

EUDAMED · 510(k)

Device Name
Disposable Nitrile Examination Gloves, Powder Free
Model / Reference
NEM0102, TG61
Primary DI / UDI-DI
06975219205871
Basic UDI-DI
697521920EM0102156286CH
Direct Marketing DI
06975219205871
EMDN Code
T01020204 Nitrile examination / treatment gloves
Device Class
Class I
EU market of registration
Ireland

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

Other properties (13)

  • 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