Reusable Adult Incontinent Diaper

• • Terminated Z-0524-2012 FDA Unclassified (pre-2012) ·initiated 9 Jan 2011 ·on shared 510(k) K883787

  Kits contain recalled Triad alcohol pads

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

510(k) Number

K883787 ↗

FDA Product Code

EYQ

Device Class

Class I

Regulation

21 CFR Part 876.5920

Advisory Committee

Gastroenterology, Urology

FDA Decision

SESE Substantially Equivalent

• Lib System, Baby/Adult Diaper

  Class I

  FDA 510(k) K891686 Active Cleared 31 May 1989

• Surgical Gown/Scrub/Laparotomy/Mayo Stand/Back Tab

  Class II

  FDA 510(k) K883424 Active Cleared 6 Sep 1988

• Mattress Cover

  Class I

  FDA 510(k) K862380 Active Cleared 28 Jul 1986

• Intera Shield and Intera Undergarment

  Class I

  FDA 510(k) K885185 Active Cleared 8 Feb 1989

• Surgical Drape & Drape Accessories

  Class II

  FDA 510(k) K863732 Active Cleared 23 Oct 1986