Skip to content

PARMADIS Disposable Vinyl Glove, Clear Color, Powder Free, Size XL

by Shandong Blue Sail Innovation Co., Ltd

Ref F29400T9Model EM 0101

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) K102161↗

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 Number697302228EM01002471765L Basic UDI-DI 06973022280467UDI-DIDate9 Feb 2022RegisteredStatusActive
United StatesFDA 510(k) 510(k) NumberK102161 Date8 Oct 2010IssuedStatusActive

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  • Withdrawn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)

Device Name
Disposable Vinyl Examination Gloves, Powder Free
Model / Reference
EM 0101, F29400T9
Primary DI / UDI-DI
06973022280467
Basic UDI-DI
697302228EM01002471765L
Direct Marketing DI
06973022280467
EMDN Code
T01020201 Vinyl examination / treatment gloves
Device Class
Class I
EU market of registration
France

Manufacturer details

EUDAMED SRN
CN-MF-000001291
Authorised representative
Lotus NL B.V. NL-AR-000000121

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

See all devices from Shandong 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