Microcool Breathable High Performance Surgical Gowns

• 2 recalls, same reason

  • Terminated Z-0258-2013 FDA Class II ·initiated 5 Jul 2012
  • Terminated Z-0257-2013 FDA Class II ·initiated 5 Jul 2012 ·via K103406, on the same 510(k)

  Package seam of some units may not remain properly sealed to ensure the contents might not be sterile as labeled.

Recalls marked "via" name another device cleared under the same FDA submission as this one.

510(k) Number

K103406 ↗

FDA Product Code

FYA

Device Class

Class II

Regulation

21 CFR Part 878.4040

Advisory Committee

General, Plastic Surgery

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 →