Rs Safe Blue Nitrile Medical Examination Gloves (Powder Free)

• 24 recalls, same reason

  • Terminated Z-1212-2016 FDA Class II ·initiated 22 Jan 2016 ·on shared 510(k) K100603
  • Terminated Z-1219-2016 FDA Class II ·initiated 22 Jan 2016 ·on shared 510(k) K100603
  • Terminated Z-1223-2016 FDA Class II ·initiated 22 Jan 2016 ·on shared 510(k) K100603
  • Terminated Z-1218-2016 FDA Class II ·initiated 22 Jan 2016 ·on shared 510(k) K100603
  • Terminated Z-1227-2016 FDA Class II ·initiated 22 Jan 2016 ·on shared 510(k) K100603
  • Terminated Z-1209-2016 FDA Class II ·initiated 22 Jan 2016 ·on shared 510(k) K100603
  • Terminated Z-1224-2016 FDA Class II ·initiated 22 Jan 2016 ·on shared 510(k) K100603
  • Terminated Z-1210-2016 FDA Class II ·initiated 22 Jan 2016 ·on shared 510(k) K100603
  • Terminated Z-1206-2016 FDA Class II ·initiated 22 Jan 2016 ·on shared 510(k) K100603
  • Terminated Z-1214-2016 FDA Class II ·initiated 22 Jan 2016 ·on shared 510(k) K100603
  • Terminated Z-1226-2016 FDA Class II ·initiated 22 Jan 2016 ·on shared 510(k) K100603
  • Terminated Z-1229-2016 FDA Class II ·initiated 22 Jan 2016 ·on shared 510(k) K100603
  • Terminated Z-1220-2016 FDA Class II ·initiated 22 Jan 2016 ·on shared 510(k) K100603
  • Terminated Z-1228-2016 FDA Class II ·initiated 22 Jan 2016 ·on shared 510(k) K100603
  • Terminated Z-1221-2016 FDA Class II ·initiated 22 Jan 2016 ·on shared 510(k) K100603
  • Terminated Z-1211-2016 FDA Class II ·initiated 22 Jan 2016 ·on shared 510(k) K100603
  • Terminated Z-1215-2016 FDA Class II ·initiated 22 Jan 2016 ·on shared 510(k) K100603
  • Terminated Z-1208-2016 FDA Class II ·initiated 22 Jan 2016 ·on shared 510(k) K100603
  • Terminated Z-1222-2016 FDA Class II ·initiated 22 Jan 2016 ·on shared 510(k) K100603
  • Terminated Z-1203-2016 FDA Class II ·initiated 22 Jan 2016 ·on shared 510(k) K100603
  • Terminated Z-1213-2016 FDA Class II ·initiated 22 Jan 2016 ·on shared 510(k) K100603
  • Terminated Z-1225-2016 FDA Class II ·initiated 22 Jan 2016 ·on shared 510(k) K100603
  • Terminated Z-1216-2016 FDA Class II ·initiated 22 Jan 2016 ·on shared 510(k) K100603
  • Terminated Z-1217-2016 FDA Class II ·initiated 22 Jan 2016 ·on shared 510(k) K100603

  Aplicare Castile Soap towelettes included in the Foley Trays and Mid stream specimen kits are contaminated with bacteria

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

510(k) Number

K100603 ↗

FDA Product Code

LZA

Device Class

Class I

Regulation

21 CFR Part 880.6250

Advisory Committee

General Hospital

FDA Decision

SESE Substantially Equivalent

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