Deroyal AM3611 - Saf-T-Glove, Light Handle Covers, Flexible (Friction Fit), Green, 1/Pk, 50 Pks/Bx, 2 Bxs/Cs
Product Overview
The Deroyal AM3611 Light Handle Cover is a premium, single-use accessory designed to maintain sterility in medical environments. These covers provide a protective barrier for surgical light handles, ensuring contamination control during procedures. Ideal for use in operating rooms, the flexible and easy-to-apply design enhances efficiency while adhering to stringent healthcare standards.
Key Benefits
- Enhanced Sterility: Protects light handles from contamination, promoting a sterile surgical environment.
- User-Friendly Design: Flexible, easy-to-apply covers ensure a snug fit on various light handle designs.
- Single-Use Convenience: Disposable covers reduce the risk of cross-contamination and simplify cleanup.
- Durable Material: High-quality material withstands rigorous surgical environments while maintaining functionality.
Deroyal AM3611 Light Handle Covers Device Characteristics
| What MRI safety information does the labeling contain? | Labeling does not contain MRI Safety Information |
| Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437) | No |
| Device labeled as "Not made with natural rubber latex" | Yes |
| For Single-Use | Yes |
| Prescription Use (Rx) | No |
| Over the Counter (OTC) | No |
| Kit | No |
| Combination Product | No |
| Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P) | No |
Compatibility and Applications
- Compatible With:
- Standard surgical light handles commonly used in operating rooms.
- Applications:
- Operating rooms, surgical suites, and other sterile environments.
- Procedures requiring contamination control for surgical lighting equipment.
Typical User Profile and Application Scenarios
- Users:
- Surgeons, nurses, and operating room technicians.
- Scenarios:
- Use during general surgeries, specialty procedures, or any application requiring sterile light handles.
Usage Guidelines
- Before use, confirm that the surgical light handle is clean and dry.
- Place the cover over the handle, ensuring a snug fit to prevent slippage.
- Dispose of the cover immediately after the procedure according to hospital protocols.
Certifications, Safety Standards, and Regulatory Approvals
- Compliance: Meets industry standards for sterility and single-use medical products.
- Latex-Free Material: Safe for use in latex-sensitive environments.
- Regulatory Approvals: Adheres to FDA and CE guidelines for medical devices.
Comparison with Competitor Products
The Deroyal AM3611 Light Handle Cover excels in flexibility, durability, and ease of application compared to competing products. Its superior material ensures reliable performance, making it a preferred choice in high-pressure surgical environments.
Best Practices for Use and Maintenance
- Store in a cool, dry place to maintain sterility until use.
- Avoid contact with sharp objects to prevent tears.
- Ensure proper disposal to maintain a sterile environment.
Regulatory and Safety Information
The product complies with all applicable regulatory standards, ensuring safety and reliability in clinical use. Latex-free composition supports use in sensitive environments, minimizing the risk of allergic reactions.
How to Order
To purchase the Deroyal AM3611 Light Handle Cover, visit the CIA Medical website or contact their customer service at (312) 275-5850. For bulk orders or inquiries, use the online contact form for prompt assistance.
