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Natural Powder Free Premium Latex Examination Gloves

by Oon Corp Resources (M) Sdn Bhd 5 variants

Ref www.ooncorp.comModel DCH2200, DCH1200, PCT2300, PCT3200, SCH2200, PCT2200, PCT2400

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) K970770↗

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 Number955591900DCH2200-1N2 Basic UDI-DI Date17 Mar 2026RegisteredStatusActive
United StatesFDA 510(k) 510(k) NumberK970770 Date14 Jul 1997IssuedStatusActive

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  • Withdrawn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
Latex Examination Gloves, Powder Free Non-sterile
Model / Reference
DCH2200, www.ooncorp.com, DCH1200, PCT2300, PCT3200, SCH2200, PCT2200, PCT2400
Primary DI / UDI-DI
09555919001415, 09555919001330, 09555919001316, 09555919000104, 09555919001224, 09555919000142, 09555919001422, 09555919001309, 09555919001200, 09555919000203, 09555919001606, 09555919000241, 09555919000050, 09555919001248, 09555919000227, 09555919000081, 09555919001439, 09555919001446, 09555919001613, 09555919001620
Basic UDI-DI
955591900DCH2200-1N2, 955591900DCH1200-1MM, 955591900PCT2300-15G, 955591900PCT3200-15J, 955591900SCH2200-1YT, 955591900PCT2200-155, 955591900PCT2400-15T
EMDN Code
T010201 Latex examination / treatment gloves
Device Class
Class I
EU market of registration
Germany

Manufacturer details

EUDAMED SRN
MY-MF-000015791
Authorised representative
MDSS GmbH DE-AR-000005430

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Properties

  • Contains Latex
  • Administering Medicine NoEUDAMEDYesEUDAMED

Other properties (11)

  • Sterile: No
  • Implantable: No
  • Reusable: No
  • Reprocessed: No
  • CMR Substance: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Endocrine Disruptor: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No