Comfit Chemo Plus Powder Free Blue Nitrile Examination Gloves, Non Sterile (Tested for Use with Chemotherapy Drug) Label

• 3 recalls, same reason

  • Terminated Z-1081-2021 FDA Class II ·initiated 7 Jan 2021 ·on shared 510(k) K002064
  • Terminated Z-1079-2021 FDA Class II ·initiated 7 Jan 2021 ·on shared 510(k) K002064
  • Terminated Z-1078-2021 FDA Class II ·initiated 7 Jan 2021 ·on shared 510(k) K002064

  Gowns included in the kits potentially have rips, holes, tears, incomplete and/or open seams, staining, foreign material or debris on the gowns.

• 4 recalls, same reason

  • Terminated Z-1284-2019 FDA Class II ·initiated 22 Mar 2019
  • Terminated Z-1286-2019 FDA Class II ·initiated 22 Mar 2019
  • Terminated Z-1285-2019 FDA Class II ·initiated 22 Mar 2019
  • Terminated Z-1283-2019 FDA Class II ·initiated 22 Mar 2019

  Kit label states not made with natural rubber latex,however safety goggles within the kits contain natural rubber latex in the goggle strap

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

510(k) Number

K002064 ↗

FDA Product Code

LZA

Device Class

Class I

Regulation

21 CFR Part 880.6250

Advisory Committee

General Hospital

FDA Decision

SESE Substantially Equivalent

• Profeel Powder Free

  Class IIa

  CE/MDR

• Dermagrip Black Nitrile

  Class I

  CE/MDR

• Comfit Powder Free

  Class IIa

  CE/MDR

• Powder Free Latex Examination Glove, Non-Sterile

  Class I

  FDA 510(k) K211601 Active Cleared 22 Aug 2022

• Powder Free Black Nitrile Examination Gloves, Non-Sterile, Tested for Use with Chemotherapy Drugs and Fentanyl Resistant

  Class I

  FDA 510(k) K210330 Active Cleared 4 Mar 2022

• Dermagrip Sterile

  Class I

  CE/MDR

See all devices from WRP Asia Pacific Sdn. Bhd. →