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Profeel Powder Free

by WRP Asia Pacific Sdn. Bhd. 8 variants

Ref P3170-21

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 23 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K000971↗

FDA record

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, FDA 510(k), synced 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number9557795LTX-SG02RC Basic UDI-DI 09557795009851UDI-DIDate18 Nov 2024RegisteredStatusActive
United StatesFDA 510(k) 510(k) NumberK000971 Date14 Apr 2000IssuedStatusActive

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 23 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  • Withdrawn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
Natural Rubber Latex Surgical Gloves, Powder Free, Sterile
Model / Reference
P3170-21
Primary DI / UDI-DI
09557795009851
Basic UDI-DI
9557795LTX-SG02RC
EMDN Code
T01010102 Non-powdered latex surgical gloves
Device Class
Class IIa
EU market of registration
Austria

Manufacturer details

EUDAMED SRN
MY-MF-000004690
Authorised representative
REMESCO HANDELSGESMBH AT-AR-000002669

Other devices from WRP Asia Pacific Sdn. Bhd.

See all devices from WRP Asia Pacific Sdn. Bhd. →

Properties

  • Sterile
  • Contains Latex

Other properties (11)

  • Implantable: No
  • Reusable: 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