Kool-Gard Backless Gown

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

Full name

Barrier Gown, Kool-Gard Backless Gown

510(k) Number

K952115 ↗

FDA Product Code

FYC

Device Class

Class II

Regulation

21 CFR Part 878.4040

Advisory Committee

General, Plastic Surgery

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

• 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 clinical settings is the Kool-Gard Backless Gown intended for use in, and how does it protect healthcare personnel?

  The Kool-Gard Backless Gown is designed for use in hospital environments during surgical and isolation procedures, including general and plastic surgery. It acts as a protective barrier to shield healthcare personnel from contamination by blocking blood, bodily fluids, and microbial contaminants, thereby reducing the risk of cross-transmission.

• Is the Kool-Gard Backless Gown reusable or intended for single-use, and how should it be stored to maintain its integrity?

  The Kool-Gard Backless Gown is explicitly intended for single-use only. To maintain sterility and integrity, storage must follow the manufacturer’s guidelines, which are provided by American Threshold Industries to ensure the gown remains uncontaminated until use.

• What regulatory pathway was followed for FDA clearance of this gown, and what classification does it hold?

  The Kool-Gard Backless Gown received FDA clearance through a Traditional 510(k) pathway (K952115) under 21 CFR 878.4040, and it is classified as a Class II medical device. The clearance was determined to be *substantially equivalent* to a predicate device, as noted in the decision description.

• Are there different sizes or models available for the Kool-Gard Backless Gown, and if so, how would a buyer determine the correct fit?

  While the provided data does not specify exact sizes or models, the gown is categorized under OpenFDA product codes (e.g., FYC) and registration numbers tied to isolation/surgical gowns. Buyers should consult the manufacturer’s product documentation or catalog for detailed sizing options (e.g., small, medium, large) to ensure proper fit for clinical staff.