iNtouch Latex Comfort-care

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

Device Name

Powder Free Latex Examination Gloves, Non-Sterile

Model / Reference

Powder Free Latex Examination Gloves, Non-Sterile, IMPS54YNA-XL

Primary DI / UDI-DI

09555256614705

Basic UDI-DI

955525660NEPFLLS

EMDN Code

T010201 Latex examination / treatment gloves

Device Class

Class I

EUDAMED SRN

MY-MF-000022331

Authorised representative

Advena Limited MT-AR-000000234

• iNtouch Powder Free

  Class IIa

  CE/MDR

• soft-hand NITRIL

  Class I

  CE/MDR

• soft-hand HI-RISK

  Class I

  CE/MDR

• iNtouch Nitrile LD Derma-care

  Class I

  CE/MDR

• soft-hand LATEX

  Class I

  CE/MDR

• Non-sterile Powder Free Nitrile Examination Glove, Dual Color (White-Green), Tested for Use with Chemotherapy Drugs, Fentanyl Citrate, Xylazine HCl, and Simulated Gastric Acid

  Class I

  FDA 510(k) K252549 Active Cleared 13 Jan 2026

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