Tyvek Self-Seal Pouches With Sterrad, Tyvek Rolls With Sterrad, Tyvek Heat-Seal…
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K103210 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)
Tyvek self-seal pouches with Sterrad, Tyvek rolls with Sterrad, and Tyvek heat-seal with Sterrad chemical indicators are packaging devices designed for instrument packaging and protection against microorganisms after terminal sterilization. They incorporate chemical indicator strips that respond to the sterilant used in STERRAD™ Systems to provide visual confirmation of exposure to the sterilization process.
These pouches and rolls are supplied non-sterile and intended for use in healthcare settings to package medical instruments prior to sterilization in STERRAD™ Systems. The self-seal variant allows sealing without heat-sealing equipment, while heat-seal pouches and rolls require heat sealing prior to sterilization. They are authorized under FDA 510(k) clearance K103210 with product code FRG.
Frequently asked questions
What are Tyvek self-seal pouches with Sterrad chemical indicators used for?
These pouches are designed for packaging medical instruments prior to sterilization in STERRAD™ Systems, providing protection against microorganisms after terminal sterilization and incorporating chemical indicator strips that visually confirm exposure to the Sterrad sterilant.
How are Tyvek self-seal pouches with Sterrad supplied, and are they sterile?
The pouches and rolls are supplied non-sterile and intended for use in healthcare settings to package instruments before sterilization; they are not sterile upon delivery and must undergo sterilization in a STERRAD™ System to achieve sterility.
What is the difference between self-seal and heat-seal Tyvek pouches with Sterrad?
Self-seal pouches can be sealed without heat-sealing equipment, while heat-seal pouches and rolls require a heat sealer prior to sterilization; both types are designed for use with STERRAD™ Systems and include Sterrad chemical indicators for process verification.
What regulatory authorization covers Tyvek self-seal pouches with Sterrad chemical indicators?
These devices are authorized under FDA 510(k) clearance K103210 with product code FRG, determined to be substantially equivalent to a legally marketed predicate device.
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: Tyvek® Pouches and Rolls with STERRAD™ Chemical Indicator (CI) Strips | ASP, Tyvek® Pouches and Rolls with STERRAD™ Chemical Indicator (CI) Strips | ASP, Sterrad Tyvek Self-Seal Pouches - Medline, Tyvek Self-seal Pouches With Sterrad, Tyvek Rolls With Sterrad, Tyvek ...
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K103210 | Class II | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Advanced Sterilization Products
Sources (1)
- FDA 510(k) K103210 24 fields · synced Oct 6, 2026