Anti-for Surgical Face Mask

No FDA recalls found in the data synced 22 Oct 2026.

510(k) Number

K905865 ↗

FDA Product Code

FXX

Device Class

Class II

Regulation

21 CFR Part 878.4040

Advisory Committee

General, Plastic Surgery

FDA Decision

SESE Substantially Equivalent

• Disposable Surgical Instrument Tip

  Class II

  FDA 510(k) K782144 Active Cleared 5 Jan 1979

• Disposable Surgical Face Mask

  Class II

  FDA 510(k) K820893 Active Cleared 14 Apr 1982

• The Protector II, Laser Surgical Mask

  Class II

  FDA 510(k) K902547 Active Cleared 5 Sep 1990

• Reliable Cone Style Face Mask

  Class II

  FDA 510(k) K913558 Active Cleared 7 Nov 1991

• Disposable Patient Blanket

  Class I

  FDA 510(k) K843038 Active Cleared 24 Oct 1984

• U.C.E.Z. Lens Cleaner Kit

  Class II

  FDA 510(k) K925659 Active Cleared 17 Sep 1993

See all devices from Anago, Inc. →

• What is the Anti-for Surgical Face Mask designed to protect against in surgical settings?

  The Anti-for Surgical Face Mask is specifically designed to create a sterile barrier between the wearer and the surgical field, blocking airborne particles, splashes, sprays, and droplets. This helps minimize contamination risks from microbial sources, ensuring a cleaner environment for both the patient and healthcare providers during procedures.

• Is this mask reusable, or is it meant for single-use only?

  This mask is explicitly intended for single-use only, as stated in its design and regulatory classification. It is supplied in sterile packaging to ensure it remains uncontaminated for one-time use in operating rooms and surgical environments.

• How should I store the Anti-for Surgical Face Mask to maintain its sterility?

  Storage instructions are provided by the manufacturer to preserve sterility and integrity. Since it is a sterile, single-use device, it should be kept in its original packaging until use, following the manufacturer’s guidelines to avoid exposure to moisture, heat, or physical damage.

• What regulatory pathway was followed for FDA clearance of this device?

  The Anti-for Surgical Face Mask received FDA clearance through a 510(k) submission (K905865), classified under product code FXX for surgical face masks. The decision was made by the Surgical Devices Panel (SU), determining it to be Substantially Equivalent (SESE) to a predicate device under the Traditional 510(k) Review process.