Synthetic Powder-Free Vinyl Patient Examination Gloves

• • Terminated Z-1645-2009 FDA Unclassified (pre-2012) ·initiated 30 Apr 2009

  The product may contain defects/holes reducing the product's effectiveness as a barrier.

510(k) Number

K992821 ↗

FDA Product Code

LYZ

FDA applicant

Shijiazhuang Hongxiang Plastics Products Co., Ltd.

Device Class

Class I

Regulation

21 CFR Part 880.6250

Advisory Committee

General Hospital

FDA Decision

SESE Substantially Equivalent

• Synthetic Powdered (White) Vinyl Patient Examination Gloves

  Class I

  FDA 510(k) K001863 Active Cleared 11 Jul 2000

• Powder Free Sterile Vinyl Glove (Clear and Yellow)

  Class I

  FDA 510(k) K053523 Active Cleared 14 Feb 2006

• Synthetic Powdered Vinyl Patient Examination Gloves

  Class I

  FDA 510(k) K992797 Active Cleared 5 Nov 1999

• Synthetic (Blue) Vinyl Patient Examination Gloves - Powder Free

  Class I

  FDA 510(k) K042247 Active Cleared 2 Sep 2004

• Pre-Powdered Sterile Vinyl Glove, Clear

  Class I

  FDA 510(k) K053521 Active Cleared 29 Mar 2006

• Synthetic Powder Free (Yellow) Vinyl Patient Examination Gloves

  Class I

  FDA 510(k) K001834 Active Cleared 30 Jun 2000

See all devices from Shijiazhuang Hongxiang Plastics Products Co;, Ltd. →