Sealsure Chemical Indicator Tape Model 14202
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K111519 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)
This device is a chemical indicator tape designed to verify exposure to physical or chemical sterilization processes. It visually confirms whether a sterilization pack or wrap has undergone a valid sterilization cycle, ensuring process assurance in both steam and low-temperature sterilization systems.
The tape is supplied as a roll, with Model 14202 available in 60-yard lengths, packaged in cases of six rolls. It is intended for single-use and must be applied to sterilization packs or wraps to seal them. The indicator changes color upon exposure to sterilization, providing a clear distinction between processed and unprocessed loads. It is approved for use with specific sterilization systems and has received FDA 510(k) clearance under the General Hospital advisory committee classification.
Frequently asked questions
What is the STERRAD SEALSURE Chemical Indicator Tape Model 14202 used for?
The STERRAD SEALSURE Chemical Indicator Tape Model 14202 is designed to verify whether sterilization packs or wraps have undergone a valid sterilization cycle. It visually confirms exposure to physical or chemical sterilization processes, ensuring process assurance in both steam and low-temperature sterilization systems. This helps healthcare providers confirm that their loads have been properly sterilized.
How is the STERRAD SEALSURE Chemical Indicator Tape Model 14202 supplied?
The tape is supplied as a roll, with each roll measuring 60 yards in length. It comes packaged in cases containing six rolls, providing a convenient quantity for healthcare facilities. This format ensures easy application to sterilization packs or wraps.
Is the STERRAD SEALSURE Chemical Indicator Tape Model 14202 intended for single-use or reuse?
The STERRAD SEALSURE Chemical Indicator Tape Model 14202 is explicitly designed for single-use only. After applying it to a sterilization pack or wrap and confirming the sterilization cycle, the tape should not be reused. This ensures accurate validation of each sterilization process.
How does the tape indicate successful sterilization?
The tape changes color upon exposure to a valid sterilization cycle, providing a clear visual distinction between processed and unprocessed loads. This color change confirms that the sterilization pack or wrap has been properly exposed to the sterilization process, ensuring reliability in process assurance.
What are the regulatory details for the STERRAD SEALSURE Chemical Indicator Tape Model 14202?
The STERRAD SEALSURE Chemical Indicator Tape Model 14202 has received FDA 510(k) clearance under the General Hospital advisory committee classification. It is classified as a Class II device and is approved for use with specific sterilization systems, ensuring compliance with regulatory standards for sterilization validation.
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: SEALSURE™ Chemical Indicator Tapes - ASP, SEALSURE™ Chemical Indicator Tapes for STERRAD | ASP, ASP Sterrad™ 14202NL Sealsure Chemical Indicator Tape, 60 yards per ..., What Is Sterrad Sterilization and How Does It Work?
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K111519 | Class II | Active |
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Manufacturer
- Manufacturer
- Advanced Sterilization Products
Sources (1)
- FDA 510(k) K111519 24 fields · synced Oct 1, 2026