SIGMA Sterilization Pouch and Roll
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K202462 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 SIGMA Sterilization Pouch and Roll is a medical device intended to provide health care workers with an effective method to enclose devices intended for sterilization. It is offered in five types, including self-sealing sterilization pouches made from medical grade plastic film that is heat sealed on three sides, with the fourth side featuring an adhesive strip for sealing, and release paper composed of a laminated PE/paper/PE structure.
The device is supplied as a sterilization packaging product and is authorized under FDA 510(k) clearance (K202462) with product code FRG. It is manufactured by Sigma Medical Supplies Corporation in New Taipei City, Taiwan, and is intended for use in general hospital settings to enclose medical devices prior to sterilization processes.
Frequently asked questions
What is the SIGMA Sterilization Pouch and Roll used for?
The SIGMA Sterilization Pouch and Roll is intended to provide health care workers with an effective method to enclose medical devices prior to sterilization processes, ensuring containment and protection during sterilization in general hospital settings.
How is the SIGMA Sterilization Pouch and Roll supplied and sealed?
The device is supplied as self-sealing sterilization pouches made from medical grade plastic film that is heat sealed on three sides, with the fourth side featuring an adhesive strip for sealing, and includes release paper composed of a laminated PE/paper/PE structure for easy opening after sterilization.
Is the SIGMA Sterilization Pouch and Roll intended for single-use or reuse?
The SIGMA Sterilization Pouch and Roll is intended for single-use only, as it is designed to enclose medical devices prior to sterilization and is not meant to be reprocessed or reused after the sterilization cycle.
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: SIGMA STERILIZATION POUCH & ROLL (K102158) — FDA 510 (k) | Innolitics, PDF 510 (K) Summary For SIGMA Sterilization Pouch and Roll, Medical Sterilization Packaging
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K202462 | Class II | Active |
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Manufacturer
- Manufacturer
- Sigma Medical Supplies Corporation
Sources (1)
- FDA 510(k) K202462 24 fields · synced Sep 26, 2026