Isolation Mask I.C.S.

No FDA recalls found in the data synced 6 Oct 2026.

510(k) Number

K831062 ↗

FDA Product Code

LGM

Device Class

Class II

Regulation

21 CFR Part 880.5450

Advisory Committee

General Hospital

FDA Decision

SESE Substantially Equivalent

• Surgical Mask (K801036)

  Class II

  FDA 510(k) K801036 Active Cleared 4 Jun 1980

• 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

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  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

See all devices from American Threshold Industries, Inc. →

• What is the Isolation Mask I.C.S. designed to do in a clinical setting?

  The Isolation Mask I.C.S. is a Class II medical device designed to create a controlled barrier around patients in hospital settings. Its purpose is to prevent airborne transmission of infectious agents, ensuring a sterile environment while still allowing essential medical access to the patient.

• Is the Isolation Mask I.C.S. meant for reuse, or is it a single-use device?

  The Isolation Mask I.C.S. is explicitly labeled as a single-use item. It is not intended for reuse, and each unit is meant for one-time sterile application in patient isolation.

• What types of hospital environments is this device approved for, and how is it regulated?

  The Isolation Mask I.C.S. is approved for use in general hospital settings and is classified as a Class II device under FDA regulations. It follows a traditional review process and holds an FDA 510(k) clearance (K831062), ensuring compliance with standards outlined in 21 CFR 880.5450.

• Are there specific storage instructions provided for this device beyond standard medical device handling?

  The regulatory data does not include specialized storage instructions such as MRI safety or size-specific requirements. However, since it is a sterile, single-use device, it should be stored according to general medical device guidelines to maintain sterility until use.