Latex Examination Gloves

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

Device Name

Latex Examination Gloves

Model / Reference

S, M, L, XL

Primary DI / UDI-DI

06976744930832, 06976744930825, 06976744930849

Basic UDI-DI

697674493LEG01QW

EMDN Code

T010201 Latex examination / treatment gloves

Device Class

Class I

Market of Registration

Austria

EUDAMED SRN

CN-MF-000008904

Authorised representative

SUNGO Europe B.V. NL-AR-000000247

• Latex Examination Gloves

  Class I

  CE/MDR

• Disposable Vinyl Examination Gloves

  Class I

  CE/MDR FDA 510(k) K223008 Active Cleared 8 Oct 2022

• Disposable Nitrile Examination Gloves

  Class I

  CE/MDR FDA 510(k) K223004 Active Cleared 4 Dec 2022

• Nitrile Examination Gloves

  Class I

  CE/MDR

• Vinyl Examination Gloves

  Class I

  CE/MDR

• Nitrile Examination Gloves

  Class I

  CE/MDR

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