Surgine Face Mask

No FDA recalls on record, checked 22 Oct 2026.

510(k) Number

K760991 ↗

FDA Product Code

FXX

Device Class

Class II

Regulation

21 CFR Part 878.4040

Advisory Committee

General, Plastic Surgery

FDA Decision

SESE Substantially Equivalent

• Edge Protector, Barrier

  Class II

  FDA 510(k) K790306 Active Cleared 22 Feb 1979

• Barrier Pediatric/Incise Drape 450

  Class II

  FDA 510(k) K780839 Active Cleared 14 Aug 1978

• Barrier General Surgery Pack

  Class II

  FDA 510(k) K760807 Active Cleared 3 Nov 1976

• Barrier Antimicrobial Incise Drape

  Class II

  FDA 510(k) K820543 Active Cleared 22 Jul 1982

• Purge Line Unit

  Class II

  FDA 510(k) K790804 Active Cleared 25 May 1979

• Sterile Surgical Scrub Brush

  Class I

  FDA 510(k) K874653 Active Cleared 30 Dec 1987

See all devices from Surgikos, Inc. →

• What is the Surgine Face Mask used for?

  The Surgine Face Mask is designed to provide a barrier during surgical procedures in general and plastic surgery settings, helping to protect both the patient and surgical team from particulate matter and fluids.

• Is the Surgine Face Mask intended for single use or reuse?

  The Surgine Face Mask is supplied as a single-use item and is not intended for reuse, as stated in its labeling and regulatory documentation to ensure patient safety and device integrity.

• When did the Surgine Face Mask receive FDA clearance?

  The Surgine Face Mask received FDA 510(k) clearance under number K760991 on November 16, 1976, following a traditional review process that determined it to be substantially equivalent to a predicate device.