Microcool Surgical Gown, Breathable High Performance KC400

• 2 recalls, same reason

  • Terminated Z-2018-2012 FDA Class II ·initiated 17 Sep 2009
  • Terminated Z-2017-2012 FDA Class II ·initiated 17 Sep 2009

  Complaints were received of gowns pilling or balling, linting and abrades, blood strikethrough and fibers falling off the gowns.

510(k) Number

K091357 ↗

FDA Product Code

FYA

Device Class

Class II

Regulation

21 CFR Part 878.4040

Advisory Committee

General, Plastic Surgery

FDA Decision

SESE Substantially Equivalent

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See all devices from Kimberly-Clark Corporation →