Sheathes (Non-Latex), Sterile
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K990175 FDA 510(k)
- FDA Product Code
- ITX FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 892.1570 FDA 510(k)
- Regulation Number
- 892.1570 FDA 510(k)
- Advisory Committee
- Radiology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Sheathes (Non-Latex), Sterile are sterile, non-latex protective covers designed for ultrasound probes. These devices serve as a barrier to prevent contamination and ensure patient and operator safety during imaging procedures, maintaining acoustic transparency to preserve image quality.
Intended for single-use in radiology settings, these covers are supplied sterile and are classified under product code ITX. They are manufactured by Sheathing Technologies, Inc., with FDA 510(k) clearance (K990175) for use with ultrasound systems, adhering to traditional review standards. The covers are available in various sizes and shapes to accommodate different probe types.
Frequently asked questions
Are these ultrasound probe covers designed for reuse, or are they meant to be used only once per patient?
These covers are explicitly intended for single-use only in radiology settings. The manufacturer, Sheathing Technologies, Inc., markets them as sterile, disposable barriers to prevent contamination and ensure patient and operator safety during ultrasound procedures. Reusing them would compromise sterility and increase infection risks, which is why they’re labeled for one-time use.
What types of ultrasound probes do these non-latex sheaths fit, and how do I know which size to order?
The sheaths come in multiple sizes and shapes to accommodate different ultrasound probe types. Since the exact dimensions aren’t specified in the data, you’d need to consult the manufacturer’s sizing guide or probe specifications to match the sheath to your probe’s diameter and shape. The key is ensuring a snug, secure fit without restricting the probe’s movement or distorting the ultrasound image.
How should I store these sterile sheaths before use to maintain their integrity?
Since these sheaths are sterile and single-use, they should be stored in their original, sealed packaging until ready for use. The packaging likely includes protective barriers (e.g., foil or plastic wraps) to preserve sterility. Avoid exposing them to moisture, extreme temperatures, or direct sunlight, and ensure the packaging remains intact until the moment of application to prevent contamination.
Why are these sheaths labeled as non-latex, and what does that mean for patients with latex allergies?
The sheaths are non-latex to eliminate the risk of allergic reactions in patients or operators who are sensitive to latex proteins. This is particularly important in medical settings where exposure to allergens could lead to adverse reactions like skin irritation, asthma, or anaphylaxis. Using non-latex materials ensures compatibility with latex-allergic individuals while still providing the necessary barrier protection.
How do I know if these sheaths are compatible with my ultrasound system, and what regulatory approval ensures their safety?
These sheaths have FDA 510(k) clearance (K990175) under the product code ITX, which means they’ve been reviewed by the FDA’s Radiology Advisory Committee (RA) and deemed substantially equivalent to a legally marketed device. The clearance confirms they meet safety and performance standards for use with ultrasound systems. However, always verify compatibility with your specific system’s probe type and manufacturer recommendations, as fit and functionality can vary.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Ultrasound Probe Covers | Sheathes, Ultrasound Probe Covers | Sheathes, Sheathing Sheathes (non-Latex), Sterile - allmed.wiki, Sheathing Technologies Nonsterile Probe Covers - Medline, Sheathes Latex-Free Sterile Probe Covers
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K990175 | Class II | Active |
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Manufacturer
- Manufacturer
- Sheathing Technologies, Inc.
Sources (1)
- FDA 510(k) K990175 24 fields · synced Sep 19, 2026