Coated Sterile Latex Powdeer-Free Surgical Gloves with Protein Content Labeling Claim (50 Microgram or LESS0

• 8 recalls, same reason

  • Completed Z-2914-2020 FDA Class II ·initiated 29 Jul 2020
  • Completed Z-2913-2020 FDA Class II ·initiated 29 Jul 2020
  • Completed Z-2912-2020 FDA Class II ·initiated 29 Jul 2020
  • Completed Z-2917-2020 FDA Class II ·initiated 29 Jul 2020
  • Completed Z-2919-2020 FDA Class II ·initiated 29 Jul 2020
  • Completed Z-2916-2020 FDA Class II ·initiated 29 Jul 2020
  • Completed Z-2915-2020 FDA Class II ·initiated 29 Jul 2020
  • Completed Z-2918-2020 FDA Class II ·initiated 29 Jul 2020

  A degradation defect was found that could lead to holes and donning tears at the folding area around the cuffs.

510(k) Number

K001924 ↗

FDA Product Code

KGO

Device Class

Class I

Regulation

21 CFR Part 878.4460

Advisory Committee

General, Plastic Surgery

FDA Decision

SESE Substantially Equivalent

• Nitrile Powder-Free Examination Gloves

  Class I

  FDA 510(k) K022765 Active Cleared 11 Oct 2002

• Powder Free Sterile Latex Examination Gloves

  Class I

  FDA 510(k) K001141 Active Cleared 9 May 2000

• Sterile Nitrile Powder-Free Examination Gloves

  Class I

  FDA 510(k) K010211 Active Cleared 15 Feb 2001

• Ultraderm Sterile Latex Powdered Surgical Sloves with Protein Content Labeling Claim (50 Micrograms or Less)

  Class I

  FDA 510(k) K991205 Active Cleared 13 Oct 1999

• Convertors Drape Material

  Class II

  FDA 510(k) K964125 Active Cleared 23 Dec 1996

• Convertors Impervious Shoe Covers

  Class I

  FDA 510(k) K970815 Active Cleared 27 Mar 1997

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