KIMTECH™ Polaris™ Nitrile Powder-Free Exam Gloves Tested for Use with Chemotherapy Drugs, Opioid Fentanyl Citrate, Simulated Gastric Acid and Fentanyl in Simulated Gastric Acid

No FDA recalls found in the data synced 25 Oct 2026.

510(k) Number

K231021 ↗

FDA Product Code

LZA

FDA applicant

Kimberly-Clark Corporation

Device Class

Class I

Regulation

21 CFR Part 880.6250

Advisory Committee

General Hospital

FDA Decision

SESE Substantially Equivalent

• Kimberly-Clark Child's Facemask

  Class II

  FDA 510(k) K113340 Active Cleared 4 May 2012

• Kotex Profile Shaped Maxi Pad

  Class I

  FDA 510(k) K871210 Active Cleared 10 Apr 1987

• Kimberly-Clark Self-Seal Pouch for Low Temperature Sterilization

  Class II

  FDA 510(k) K973827 Active Cleared 11 Feb 1998

• Kotex Security Tube Tampons

  Class II

  FDA 510(k) K885194 Active Cleared 1 Mar 1989

• Spunguard Face Mask Open recall

  Class II

  FDA 510(k) K823078 Active Cleared 7 Jan 1983

• Kotex Super Maxi Pads

  Class II

  FDA 510(k) K890013 Active Cleared 25 Apr 1989

See all devices from Kimberly-Clark Corporation →