Surgical Mask (K801036)

• • Terminated Z-0944-03 FDA Unclassified (pre-2012) ·initiated 3 Jun 2003

  The product labeling incorrectly lists the particle filtration efficiency as exceeding 99% at 0.1 micron when it should state 95% filtration.

Full name

Surgical Mask

510(k) Number

K801036 ↗

FDA Product Code

FXX

Device Class

Class II

Regulation

21 CFR Part 878.4040

Advisory Committee

General, Plastic Surgery

FDA Decision

SESE Substantially Equivalent

• Or/Cs Wrap

  Class II

  FDA 510(k) K810646 Active Cleared 20 Mar 1981

• Disposable Shoe Cover

  Class I

  FDA 510(k) K894383 Active Cleared 12 Sep 1989

• Kool-Gard Backless Gown

  Class II

  FDA 510(k) K952115 Active Cleared 25 Sep 1995

• Infection Control Towel

  Not classified

  FDA 510(k) K822484 Active Cleared 30 Sep 1982

• Kool Gard Singles Gown

  Class II

  FDA 510(k) K952114 Active Cleared 25 Sep 1995

• Surgeon's Cap

  Class I

  FDA 510(k) K953879 Active Cleared 5 Jan 1996

See all devices from American Threshold Industries, Inc. →

• What is the primary purpose of this surgical mask in a clinical setting?

  This surgical mask is designed to protect both surgical patients and healthcare personnel by blocking the transfer of microorganisms, body fluids, and particulate matter during surgical procedures. It is specifically intended for use in operating rooms and other controlled surgical environments where maintaining sterility is critical.

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

  The mask is explicitly labeled as a single-use item, meaning it should not be reused after a single procedure. This aligns with standard practices for disposable surgical apparel to ensure sterility and prevent contamination.

• How should I store this mask to maintain its integrity?

  Storage and handling must follow standard protocols for surgical apparel to preserve sterility. The mask should be kept in a clean, dry environment, away from direct sunlight or extreme temperatures, and protected from physical damage until use.

• What regulatory pathway was followed for this device’s approval?

  This surgical mask received FDA clearance through a 510(k) submission (K801036) filed in 1980 under the Traditional 510(k) Review pathway. It was determined to be Substantially Equivalent to a legally marketed predicate device and reviewed by the Orthopaedic and Rehabilitation Devices Advisory Committee (SU).