Chemo Plus Powder Free Blue Latex Examination Gloves (Protein Content Labeling)

• 3 recalls, same reason

  • Terminated Z-1083-2021 FDA Class II ·initiated 7 Jan 2021 ·on shared 510(k) K972615
  • Terminated Z-1082-2021 FDA Class II ·initiated 7 Jan 2021 ·on shared 510(k) K972615
  • Terminated Z-1080-2021 FDA Class II ·initiated 7 Jan 2021 ·on shared 510(k) K972615

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

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

510(k) Number

K972615 ↗

FDA Product Code

LYY

Device Class

Class I

Regulation

21 CFR Part 880.6250

Advisory Committee

General Hospital

FDA Decision

SESE Substantially Equivalent

• Scinitrex (Powder Free Nitrile Examination Gloves)

  Class I

  FDA 510(k) K952051 Active Cleared 15 Dec 1995

• Scipotex

  Class I

  FDA 510(k) K945785 Active Cleared 28 Apr 1995

• Comfit Powered Examination Gloves(Beaded, Hypoallerg)

  Class I

  FDA 510(k) K935866 Active Cleared 18 May 1994

• Comfit Blue Powder Free Examination Gloves

  Class I

  FDA 510(k) K943563 Active Cleared 7 Mar 1995

• Comfit, Patient Examination Gloves

  Class I

  FDA 510(k) K903746 Active Cleared 5 Sep 1990

• Scinitrex (Green Powdered Nitrile Examination Gloves)

  Class I

  FDA 510(k) K951921 Active Cleared 30 Oct 1995

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