Powder Free Vinyl Patient Examination Gloves (Light Yellow)

• 2 recalls, same reason

  • Terminated Z-1553-2011 FDA Unclassified (pre-2012) ·initiated 3 Feb 2011 ·on shared 510(k) K081655
  • Terminated Z-1554-2011 FDA Unclassified (pre-2012) ·initiated 3 Feb 2011 ·on shared 510(k) K081655

  The recall was initiated because the affected lot, lot number JCU004958569, of gloves did not meet the requirements for the water-leak test.

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

510(k) Number

K081655 ↗

FDA Product Code

LYZ

Device Class

Class I

Regulation

21 CFR Part 880.6250

Advisory Committee

General Hospital

FDA Decision

SESE Substantially Equivalent

• CureGuard

  Class I

  CE/MDR

• Rubber-Like Powder Free Vinyl Patient Examination Gloves, White Color

  Class I

  FDA 510(k) K093576 Active Cleared 4 Mar 2010

• Disposable Synthetic Vinyl Nitrile Examination Glove

  Class I

  CE/MDR FDA 510(k) K211354 Active Cleared 8 Aug 2021

• Powdered Vinyl Patient Examination Gloves, (Light Yellow)

  Class I

  FDA 510(k) K081657 Active Cleared 20 Aug 2008

• Powdered Vinyl Patient Examination Gloves, Clear (Non-Colored)

  Class I

  FDA 510(k) K070075 Active Cleared 9 Feb 2007

• Powder Free Vinyl Patinet Examination Gloves, Clear (Non-Colored)

  Class I

  FDA 510(k) K070076 Active Cleared 22 Feb 2007

See all devices from Jiangsu Cureguard Glove Co., Ltd. →