Aero Chrome Breathable Performance Surgical Gown

No FDA recalls on record, checked 22 Oct 2026.

510(k) Number

K153255 ↗

FDA Product Code

FYA

Device Class

Class II

Regulation

21 CFR Part 878.4040

Advisory Committee

General, Plastic Surgery

FDA Decision

SESE Substantially Equivalent

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See all devices from Halyard Health →

• Is this gown suitable for reuse in a clinical setting, and if not, why is it designed for single-use?

  No, the Aero Chrome Breathable Performance Surgical Gown is explicitly designed for single-use only. This is because surgical gowns are intended to provide a sterile barrier during procedures, and reuse could compromise fluid resistance, sterility, or comfort—especially after exposure to bodily fluids or contaminants. Single-use also aligns with infection control best practices to prevent cross-contamination between patients.

• What level of fluid resistance does this gown provide, and how does that translate to real-world surgical use?

  The gown meets AAMI Level 4 protection, which means it offers the highest barrier performance against liquid penetration among standard surgical gowns. In practical terms, this ensures strong resistance to splashes, sprays, and even some low-pressure jets of fluids (like blood or surgical irrigants) during procedures, reducing the risk of contamination to the wearer. This level is ideal for high-risk surgeries where fluid exposure is likely.

• How should I store these gowns to ensure they remain effective when needed?

  Since the Aero Chrome gowns are non-sterile, storage should follow standard protocols for surgical attire to preserve their integrity. Keep them in a cool, dry environment away from direct sunlight or extreme temperatures, which could degrade the fabric or fluid-resistant properties. Store them in their original packaging to prevent contamination or damage, and ensure the packaging remains sealed until use. Avoid stacking heavy items on top of the gowns to prevent crushing or distortion.

• Why is this gown silver in color, and does the color affect its performance?

  The silvery color is a design feature for easy identification in operating rooms, helping clinicians quickly distinguish it from other gowns or drapes. The color does not impact its performance—fluid resistance, breathability, or barrier properties are determined by the material composition (not the dye or finish). The gown’s performance is validated through testing per AAMI Level 4 standards, regardless of its visual appearance.

• Are there different sizes or models available for this gown, and how do I determine the right fit for my facility?

  While the provided data does not specify exact sizes or models, most surgical gowns from Halyard Health (including this line) typically offer standard adult sizes (e.g., small, medium, large, extra-large) to accommodate varying patient and clinician body types. Facilities should refer to Halyard’s product documentation or consult their distributor to confirm available sizes and ensure the gown provides adequate coverage and mobility for their staff. A proper fit is critical for both comfort and fluid resistance.