Convertors Impervious Shoe Covers

No FDA recalls on record, checked 22 Oct 2026.

510(k) Number

K970815 ↗

FDA Product Code

FXP

Device Class

Class I

Regulation

21 CFR Part 878.4040

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

• Flexible Vascular Clamp, Version 2

  Class II

  FDA 510(k) K991589 Active Cleared 18 May 1999

See all devices from Allegiance Healthcare Corp. →