Disposable Surgeon Gown - ETO Sterile

Advance Information*

Introduction

The Curesafe Disposable Surgeon Gown with ETO Sterile Face Mask, Surgeon Cap, and Hand Towel is a carefully designed and meticulously crafted product aimed at ensuring the utmost protection, comfort, and efficiency for healthcare professionals in a surgical setting. Manufactured under stringent quality control and adhering to global health standards, these gowns are an integral part of maintaining a sterile environment during surgical operations.

Key Features

Comprehensive Protective Kit

• Package Components: Each set includes a Curesafe Disposable Surgeon Gown, an ETO Sterile Face Mask, a Surgeon Cap, and a Hand Towel. This ensures all necessary protective gear is available, promoting a seamless and efficient surgical process.

High Standards of Certification

• Certifications and Approvals: The gown and accompanying accessories are manufactured following the cGMP guidelines and are ISO 13485:2016, CE, FDA approved, as well as IAF and IAS certified. This guarantees that the product meets the highest standards of safety and quality.

Superior Fabric and Design

• Material: The gown is made from SMMS fabric, which is known for its excellent filtration, strength, and comfort properties.
• Knit Cuff and Full Back Design: The gown features a knit cuff and full back design that ensures dependable coverage against contaminants while also providing comfort and ease of movement for the wearer.

Sterility and Hygiene

• ETO Sterilization: Sterility is guaranteed as long as the package remains undamaged. ETO (Ethylene Oxide) sterilization is highly effective at eliminating microbes, ensuring that the gown and other included items are safe for surgical use.
• Sterility Assurance: The gown's sterility is validated through rigorous testing and quality control measures, providing confidence in its ability to maintain a sterile field.

Detailed Breakdown of Components

Surgeon Gown

• SMMS Fabric: SMMS (Spunbond-Meltblown-Meltblown-Spunbond) fabric is a medical-grade material known for its breathability, strength, and protective qualities. It offers superior protection against fluids, making it an ideal choice for environments with a high potential for fluid exposure.
• Knit Cuff: The knit cuffs are designed to be gentle on the skin while providing a snug fit that prevents the sleeves from riding up, maintaining coverage and protection.
• Full Back Coverage: The design includes full back coverage, which helps to ensure that the entire torso is protected from contaminants.

ETO Sterile Face Mask

• High Filtration Efficiency: The face mask included in the kit is ETO sterile and provides high filtration efficiency, offering effective protection against airborne particles and fluid splashes.
• Comfort and Fit: Designed for comfort, the mask ensures a secure fit around the nose and mouth, reducing the risk of contamination.

Surgeon Cap

• Secure Fit: The surgeon cap provides a secure and comfortable fit, ensuring that hair and other particles are properly contained.
• Breathable Material: Made from breathable materials, the cap ensures comfort even during long surgical procedures.

Hand Towel

• Absorbent Material: The included hand towel is made from highly absorbent material, making it ideal for use in surgical settings.
• ETO Sterilized: Like the other components, the hand towel is ETO sterilized, ensuring it is free from contaminants.

Certifications and Compliance

The Curesafe Disposable Surgeon Gown kit meets and exceeds multiple global health and safety standards: - cGMP Compliance: The manufacturing process adheres to current Good Manufacturing Practices (cGMP), ensuring products are consistently produced and controlled according to quality standards. - ISO 13485:2016 Certification: This certification ensures that the product meets international standards specific to medical devices, indicating robust quality management systems are in place. - CE Marking: The product complies with European health, safety, and environmental protection standards. - FDA Approval: The gowns are approved by the U.S. Food and Drug Administration (FDA), signifying their safety and efficacy. - IAF and IAS Certification: The products are certified by the International Accreditation Forum (IAF) and the International Accreditation Service (IAS), reinforcing the product’s high quality and global compliance.

Use Case Scenarios

Curesafe Disposable Surgeon Gowns are ideal for various medical settings, including: - Operating Rooms: Essential for maintaining sterility during surgical procedures. - Emergency Rooms: Useful in situations where there is a high potential for exposure to blood and other body fluids. - Infection Control Areas: Ideal for use in isolation units to prevent the spread of infectious diseases. - Outpatient Clinics: Suitable for minor surgical procedures and other medical interventions that require sterile conditions.

Advantages Over Regular Medical Gowns

Enhanced Protection

• Fluid Resistance: The SMMS fabric provides superior protection against fluids, a significant advantage in environments