Isolation Masks

No FDA recalls on record, checked 22 Oct 2026.

510(k) Number

K893939 ↗

FDA Product Code

FXX

Device Class

Class II

Regulation

21 CFR Part 878.4040

Advisory Committee

General, Plastic Surgery

FDA Decision

SESE Substantially Equivalent

• Caretex or Towel

  Class II

  FDA 510(k) K884112 Active Cleared 13 Oct 1988

• Central Supply Room Wrap

  Class II

  FDA 510(k) K823513 Active Cleared 7 Jan 1983

• Visulin Transparent Adhesive Dressing

  Class I

  FDA 510(k) K894147 Active Cleared 9 Aug 1989

• Caretex Surgeon's Caps

  Class I

  FDA 510(k) K880481 Active Cleared 24 Feb 1988

• Caretex Central Supply Wrap

  Class II

  FDA 510(k) K883802 Active Cleared 21 Oct 1988

• Caretex Skid Resistant Shoe Covers

  Class I

  FDA 510(k) K880093 Active Cleared 29 Jan 1988

See all devices from James River Corp. →