Vasco Guard Long

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

Device Name

Nitrile Examination Gloves

Model / Reference

Nitrile Powder Free Examination Gloves, 9205526

Primary DI / UDI-DI

04046955140640

Basic UDI-DI

955524480HSBTFMD002A5A

Unit of Use DI

04046955140633

EMDN Code

T01020204 Nitrile examination / treatment gloves

Device Class

Class I

Market of Registration

Germany

EUDAMED SRN

MY-MF-000010461

Authorised representative

MDSS GmbH DE-AR-000005430

• Nitrile Powder Free Examination Glove with Colloidal Oatmeal USP Skin Protectant and Tested for Use With Chemotherapy Drugs (Dawn Blue)

  Class I

  FDA 510(k) K171874 Active Cleared 12 Oct 2017

• Nitrile Powder Free Examination Gloves with Colloidal Oatmeal - Lemon Green

  Class I

  FDA 510(k) K180644 Active Cleared 10 Aug 2018

• Nitrile Powder Free Examination Glove with Colloidal Oatmeal USP Tested for Use with Chemotherapy Drugs

  Class I

  FDA 510(k) K162819 Active Cleared 9 Jan 2017

• Latex Powder Free Examination Gloves with Colloidal Oatmeal Usp Skin Protectant Drug with Protein Labeling Claim of 50 M

  Class I

  FDA 510(k) K133953 Active Cleared 28 May 2014

• Nitrile Powder Free Examination Glove with Colloidal Oatmeal USP with Low-Dermatitis Potential Claim and Tested For Use with Chemotherapy Drugs (White)

  Class I

  FDA 510(k) K180505 Active Cleared 14 Jun 2018

• Powder Free Examination Gloves with Colloidal Oatmeal USP and Tested for Use with Chemotherapy Drugs - (Lemon Green)

  Class I

  FDA 510(k) K180645 Active Cleared 16 Nov 2018

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