Surgical Gowns Explained: Types, Standards & How to Choose the Right One

The Ultimate Guide to Surgical Gowns: Features, Standards & Selection Criteria

In the ever-evolving world of healthcare, maintaining sterility and minimizing infection risk is of paramount importance. Among the essential personal protective equipment (PPE) used by healthcare professionals, surgical gowns stand out as one of the most vital. These gowns act as barriers, shielding both medical personnel and patients from contamination, infections, and bodily fluids during surgical and procedural interventions. With advancements in technology and stricter safety standards, understanding surgical gown classifications and usage is crucial for every healthcare facility.

What is a Surgical Gown?
A surgical gown is a protective garment worn by medical personnel during surgeries and medical procedures. Designed to maintain a sterile environment, it protects both the wearer and the patient from microbial transfer, bodily fluids, and other potentially infectious materials. Unlike general-purpose isolation gowns, surgical gowns are used in operating rooms and are subject to stringent regulatory oversight to ensure they meet critical safety and performance standards. These gowns are engineered to serve two main roles: preventing contamination of the surgical site and protecting medical staff from exposure.

Regulatory Standards for Surgical Gowns
Surgical gowns must meet strict international standards to ensure safety and reliability:

• FDA (U.S.) – Classifies gowns as Class II medical devices and requires premarket 510(k) approval.
• AAMI PB70 – Defines four protection levels based on fluid barrier performance.
• CE Marking (Europe) – Requires compliance with MDR and EN 13795 for microbial cleanliness and protection.
• ISO Standards – Especially ISO 13485, ensures quality control in medical device manufacturing.
• CDC Guidelines – Provide PPE usage protocols, including gown selection and disposal.

Types of Surgical Gowns

Sterile Surgical Gowns
Used in operating rooms and high-risk environments, these gowns are sterilized with EO or radiation and individually packaged to ensure asepsis. Ideal for cardiovascular, transplant, orthopedic, and trauma procedures.

Non-Sterile Surgical Gowns
These are used in general medical settings where sterility is not required. While not sterile, they are manufactured under hygienic conditions and provide basic protection against splashes and contamination.

Disposable vs. Reusable Surgical Gowns

• Infection Control: Disposable gowns reduce SSI risk by up to 40%. They are single-use, minimizing reprocessing errors.
• Convenience: Always ready-to-use, disposables offer consistent quality and eliminate the need for laundering.
• Clinical Studies: One study showed a 26% reduction in wound infections when disposable drapes and gowns were used compared to reusable ones.

Key Factors in Selecting a Surgical Gown

• Barrier Protection: Choose based on AAMI levels (1 to 4), depending on fluid exposure risk.
• Comfort & Fit: Look for ergonomic designs and sizing options that allow mobility.
• Material & Breathability: Non-woven breathable fabrics provide a balance between protection and comfort.
• Sterilization Compatibility: Ensure the gown supports EO or steam sterilization if sterility is needed.
• Standard Compliance: Confirm certifications like AAMI PB70, EN 13795, ISO 11135.
• Critical Zones: Front (chest to knees) and sleeves (cuff to elbow) should have the highest level of protection.

AAMI Levels of Protection

• Level 1 – Minimal Risk: For basic care and minimal fluid exposure.
• Level 2 – Low Risk: Suitable for blood draws and sutures with low fluid spray.
• Level 3 – Moderate Risk: Used in ER or ICU, for arterial blood draws and moderate exposure.
• Level 4 – High Risk: Required for trauma, long-duration or high-fluid surgeries; resists viral and blood penetration (ASTM F1670/F1671).

CDC Guidelines for Gown Use in Healthcare Settings

• Match gown level to procedure risk.
• Use proper donning and doffing technique to avoid contamination.
• Dispose of used gowns in accordance with biohazard regulations.

Request a Quote for Reusable Surgical Gowns & Coveralls
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