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Powdered Latex Examination Gloves

by Tan Sin Lian Industries Sdn. Bhd.

Ref LEGPPS

Active European Union. Also listed in GUDID (US).

CE MDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

None found

in data synced 22 Oct 2026

Documents

None, self-declared

Class I: no certifier involved

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, GUDID, synced 22 Oct 2026. What this means

Overview

Powdered Latex Examination Gloves are a highly specialized medical device designed for sterile handling and examination of human tissues. These gloves feature multiple layers of protection, including latex and endocrine disruptors, making them ideal for use in clinical settings.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing GUDID Number09555697505068 UDI-DI Date4 Jul 2023ListedStatusListed GUDID: in commercial distribution
European UnionCE/MDR EUDAMED Number955569750LEGW4 Basic UDI-DI Date19 Jan 2023RegisteredStatusActive

Certificates

0 certificates · EUDAMED

No certifier certificate is listed. Devices of this class are self-declared by the manufacturer.

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States GUDID listing Listed

Specification

EUDAMED · GUDID

Trade Name
Powdered Latex Examination Gloves EUDAMED
Qualatex GUDID
Generic Name
Hevea-latex examination/treatment glove, powdered
Model / Ref / Catalog
LEGPPS, LEGPPS XS, LEGPPS L, LEGPPS S
Primary DI / UDI-DI
09555697505068, 09555697505099, 09555697505075
Basic UDI-DI
955569750LEGW4
510(k) Number
FDA Product Code
LYY
EMDN Code
T010201 Latex examination / treatment gloves
GMDN Term
Hevea-latex examination/treatment glove, powdered
Device Class
Class I
Regulation Number
880.6250
EU market of registration
Belgium
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Model / ReferenceEUDAMED
LEGPPS
GUDID
LEGPPS XS
LEGPPS L
LEGPPS S

Manufacturer details

EUDAMED SRN
MY-MF-000024147
Authorised representative
Obelis s.a. BE-AR-000000106

Other devices from Tan Sin Lian Industries Sdn. Bhd.

See all devices from Tan Sin Lian Industries Sdn. Bhd. →

Properties

  • Single Use
  • Contains Latex
  • Expiration Date
  • Manufacturing Date

Other properties (20)

  • Sterile: No
  • 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
  • Prescription Use: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Lot / Batch Number: No
  • Serial Number: No