TSO3 Ozone Sterilization Wrap
FDA 510(k)Class II (US FDA 510(k))
by Tso3, Inc.
Identifiers
- 510(k) Number
- K080198 FDA 510(k)
- FDA Product Code
- FRG FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 880.6850 FDA 510(k)
- Regulation Number
- 880.6850 FDA 510(k)
- Advisory Committee
- General Hospital FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Tso3 Ozone Sterilization Wrap is a sterilization wrap intended to enclose other medical devices for ozone‑based sterilization processes. It functions as a barrier that allows the sterilant to penetrate while protecting the wrapped item during the cycle.
The wrap is supplied as a single‑use, non‑sterile product and is classified as a Class 2 device (product code FRG) with FDA 510(k) clearance (K080198) based on substantial equivalence. It is intended for use in general hospital settings and is not reusable.
Frequently asked questions
What is the TSO3 Ozone Sterilization Wrap used for?
The wrap serves as a barrier for medical devices that are processed in ozone‑based sterilization cycles. It is designed to let the ozone sterilant penetrate the package so the enclosed item is sterilized, while simultaneously protecting the item from physical damage or contamination during the cycle.
How is the wrap supplied and what is its sterility status?
It is supplied as a single‑use, non‑sterile product. Because it is intended to be placed around a device that will be sterilized, the wrap itself does not need to be sterile before use; the ozone cycle provides the required sterility for the wrapped item.
Can the TSO3 Ozone Sterilization Wrap be reused?
No, the wrap is designated for single‑use only. Reuse could compromise its barrier integrity and affect the ability of ozone to penetrate, which would jeopardize the sterility of subsequent loads.
Are there different sizes or models of this wrap?
The provided data does not list multiple sizes or model numbers; the product is identified simply as the TSO3 Ozone Sterilization Wrap. If size variations exist, they are not specified in the current regulatory information.
What regulatory clearance does the wrap have?
The device is classified as a Class 2 medical device (product code FRG) and has received traditional FDA 510(k) clearance (K080198) based on substantial equivalence, indicating it meets the necessary safety and performance standards for its intended use.
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: TSO3 OZONE STERILIZATION WRAP (K080198) — FDA 510(k) | Innolitics, TSO3 OZONE STERILIZATION WRAP 510 (k) K080198 - FDA.report, K080198 - Wrap, Sterilization FDA 510 (k) APPLICATION FOR TSO3 INC., PDF T SC 1,. KO20875 TS03-125L Ozone - Food and Drug Administration
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K080198 | Class II | Active |
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Manufacturer
- Manufacturer
- Tso3, Inc.
Sources (1)
- FDA 510(k) K080198 24 fields · synced Sep 28, 2026