Safety + Comfort

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

Device Name

Latex Examination Powder Free Gloves

Model / Reference

ABO-971982023

Primary DI / UDI-DI

08859719820230

Basic UDI-DI

885971980880TF

EMDN Code

T010201 Latex examination / treatment gloves

Device Class

Class I

EU market of registration

Poland

EUDAMED SRN

TH-MF-000018387

Authorised representative

Ulma International GmbH DE-AR-000010015

• Safety + Comfort

  Class I

  CE/MDR

• Polymer Coated Powderfree Latex Examination Glove

  Class I

  FDA 510(k) K022016 Active Cleared 15 Oct 2002

• Top Glove Medical (Thailand) Powdered Latex Examination Gloves

  Class I

  FDA 510(k) K021950 Active Cleared 1 Aug 2002

• Nitrile Examination Powder Free Glove, Blue Tested For Use With 32 Chemotherapy Drugs and Fentanyl Permeation Resistance Claim, Nitrile Examination Powder Free Glove, Black Tested For Use With 32 Chemotherapy Drugs and Fentanyl Permeation Resistance Claim

  Class I

  FDA 510(k) K222129 Active Cleared 10 Feb 2023

• Safety + Comfort

  Class I

  CE/MDR

• Safety + Comfort

  Class I

  CE/MDR

See all devices from Top Glove Medical (Thailand) Co., Ltd. →