Surgical Face Mask-Ear Loop

No FDA recalls on record, checked 22 Oct 2026.

510(k) Number

K891051 ↗

FDA Product Code

FXX

Device Class

Class II

Regulation

21 CFR Part 878.4040

Advisory Committee

General, Plastic Surgery

FDA Decision

SESE Substantially Equivalent

• Non-Sterile Gauze Sponge

  Class I

  FDA 510(k) K891054 Active Cleared 1 May 1989

• Surgical Cone Mask

  Class II

  FDA 510(k) K891056 Active Cleared 12 Apr 1989

• Dental Bib

  Class II

  FDA 510(k) K891053 Active Cleared 12 Apr 1989

• Splash Guard Goggle

  Class II

  FDA 510(k) K891052 Active Cleared 12 Apr 1989

• Dental Gown

  Class II

  FDA 510(k) K891058 Active Cleared 12 Apr 1989

• Patient Exam Gloves (Mfg. Ammatex)

  Class I

  FDA 510(k) K892748 Active Cleared 10 Aug 1989