Ai Glove

Device Name

Latex Exam Polymer Powder Free Gloves

Model / Reference

A1G-100457664

Primary DI / UDI-DI

09551004576646

Market of Registration

Cyprus

EUDAMED SRN

MY-MF-000020464

Authorised representative

Ulma International GmbH DE-AR-000010015

• Ai Glove

  Class I

  CE/MDR

• Nitrile Blue Powder Free Examination Gloves with Low Dermatitis Potential Claim and Tested for Use with Chemotherapy Drugs

  Class I

  FDA 510(k) K163017 Active Cleared 22 Mar 2017

• Nitrile Powder Free Examination Glove, Blue Tested for Use with 32 Chemotherapy Drugs and Fentanyl Permeation Resistance Claim

  Class I

  FDA 510(k) K260312 Active Cleared 8 Sep 2026

• GMP Medicare XXL

  Class I

  GUDID on market

• GMP Medicare

  Class I

  GUDID on market

• GMP Medicare S

  Class I

  GUDID on market

See all devices from Gmp Medicare Sdn. Bhd. →