Identifiers
- 510(k) Number
- K240910 FDA 510(k)
- FDA Product Code
- JOJ FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 880.2800 FDA 510(k)
- Regulation Number
- 880.2800 FDA 510(k)
- Advisory Committee
- General Hospital FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The EO Chex Indicator Tape is a Physical/Chemical Sterilization Process Indicator designed to verify exposure to ethylene oxide (EO) gas sterilization. It visually confirms whether medical packs have undergone the sterilization process by changing color from pink to orange-brown, ensuring only properly processed items are used in clinical settings.
This tape is supplied as a single-use, non-sterile indicator and is intended for use in general hospital settings. It is applied to wrapped packs by healthcare providers and must be stored in a dry environment before use. The device holds FDA 510(k) clearance (K240910) and is classified under Class II medical devices, adhering to regulatory standards for physical/chemical sterilization indicators.
Frequently asked questions
What is the EO Chex Indicator Tape used for?
The EO Chex Indicator Tape is designed to verify whether medical packs have been properly exposed to ethylene oxide (EO) gas sterilization. It changes color from pink to orange-brown after exposure, ensuring only correctly sterilized items are used in clinical settings. This visual confirmation helps prevent the use of improperly processed medical supplies, which could compromise patient safety.
Is the EO Chex Indicator Tape sterile or non-sterile?
The EO Chex Indicator Tape is supplied as a non-sterile device. It is intended to be applied externally to wrapped medical packs before sterilization, not as part of the sterile field itself. Its purpose is to confirm sterilization exposure, not to maintain sterility.
How should the EO Chex Indicator Tape be stored before use?
The tape must be stored in a dry environment before use. Moisture or humidity could affect its accuracy in detecting ethylene oxide exposure. Proper storage ensures the indicator remains reliable when applied to medical packs for sterilization verification.
Can the EO Chex Indicator Tape be reused?
No, the EO Chex Indicator Tape is single-use only. Once applied to a medical pack and exposed to ethylene oxide, it changes color permanently, indicating successful sterilization. Reusing it would provide inaccurate results, as the indicator cannot revert to its original state.
What regulatory clearance does the EO Chex Indicator Tape hold?
The EO Chex Indicator Tape holds FDA 510(k) clearance (K240910) and is classified as a Class II medical device. This clearance confirms it meets regulatory standards for physical/chemical sterilization process indicators, ensuring its reliability in verifying ethylene oxide sterilization cycles.
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: Propper Manufacturing Company Announces FDA Clearance of New EO Chex ..., Indicator Tape - Propper Manufacturing, PDF Propper Manufacturing Co., Inc. Andrew Sharavara Chief Technical Officer, Propper Manufacturing Company Announces FDA Clearance of New EO Chex ...
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K240910 | Class II | Active |
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Manufacturer
- Manufacturer
- Propper Manufacturing Co., Inc.
Sources (1)
- FDA 510(k) K240910 24 fields · synced Oct 1, 2026