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Disposable Nitrile Examination Gloves, 4.0g Series, Powder-free, Blue, XS

by Zibo Blue Sail Health Technology Co., Ltd.

Ref Nitrile 4.0g EM series_XS, Nitrile 4.0g EM series_L, Nitrile 4.0g EM series_MModel EM0102

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 24 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K221229↗

FDA record

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, FDA 510(k), synced 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number697521922EM0102156286F3 Basic UDI-DI Date17 Nov 2022RegisteredStatusActive
United StatesFDA 510(k) 510(k) NumberK221229 Date16 Jul 2022IssuedStatusActive

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 24 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  • Withdrawn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)

Trade Name
Disposable Nitrile Examination Gloves, 4.0g Series, Powder-free, Blue, XS
Disposable Nitrile Examination Gloves, 4.0g Series, Powder-free, Blue, L
Disposable Nitrile Examination Gloves, 4.0g Series, Powder-free, Blue, M
Device Name
Disposable Nitrile Examination Gloves, Powder Free
Model / Reference
EM0102, Nitrile 4.0g EM series_XS, Nitrile 4.0g EM series_L, Nitrile 4.0g EM series_M
Primary DI / UDI-DI
06975219221284, 06975219221314, 06975219221307
Basic UDI-DI
697521922EM0102156286F3
Direct Marketing DI
06975219221284
06975219221314
06975219221307
EMDN Code
T01020204 Nitrile examination / treatment gloves
Device Class
Class I
EU market of registration
Denmark

Manufacturer details

EUDAMED SRN
CN-MF-000023102
Authorised representative
Lotus NL B.V. NL-AR-000000121

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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