Comfort Nitrile PF Exam Gloves 4.0g

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

• • Terminated Z-0051-2021 FDA Class II ·initiated 19 Aug 2020 ·on shared 510(k) K974424

  Examination gloves were shipped inadvertently, without to verify barrier integrity.

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

Model / Reference

Comfort Nitrile PF Exam Gloves 4.0

Primary DI / UDI-DI

09551003830329

Basic UDI-DI

955100383032BV

EMDN Code

T010299 Examination / treatment gloves - other

Device Class

Class I

EU market of registration

Sweden

EUDAMED SRN

MY-MF-000029060

Authorised representative

Emergo Europe B.V. NL-AR-000000116

• Nitrile Powder Free Examination Gloves (Blue)

  Class I

  FDA 510(k) K241528 Active Cleared 6 Aug 2024

• Powder Free Nitrile Examination Gloves (Orange)

  Class I

  FDA 510(k) K171541 Active Cleared 20 Sep 2017

• Power Free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs and Fentanyl

  Class I

  FDA 510(k) K192954 Active Cleared 19 Jun 2020

• Powder Free Natural Rubber Latex Examination Gloves – Blue, Non-Sterile and Protein Claim Of 50 Micrograms per dm2 Or Less Protein

  Class I

  FDA 510(k) K250069 Active Cleared 29 Apr 2025

• Powder Free Nitrile (Black) Examination Gloves

  Class I

  FDA 510(k) K110297 Active Cleared 15 Jun 2011

• Powder Free Nitrile Examination Gloves Tested For Use With Chemotherapy Drugs Labeling Claim (White); Powder Free Nitrile Examination Gloves Tested For Use With Chemotherapy Drugs Labeling Claim (Blue)

  Class I

  FDA 510(k) K162405 Active Cleared 28 Mar 2017

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