← Back to catalogue

Sigma Sterilization Pouch & Roll

FDA 510(k)

Class II (US FDA 510(k))

510(k) K102158

by Sigma Medical Supplies Corp.

Identifiers

510(k) Number
K102158 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 & Roll is a medical sterilization pouch designed for packaging instruments and supplies prior to sterilization. It features a medical-grade plastic film with a self-sealing adhesive strip on one side, ensuring a secure barrier to maintain sterility.

This pouch is supplied in roll form for convenient use in clinical settings and is intended for single-use applications. The release paper within the pouch consists of a laminated structure of polyethylene/paper/polyethylene. Authorized for use in the United States under FDA 510(k) clearance (K102158, K180661, K202462), it adheres to regulatory standards for sterilization packaging.

Frequently asked questions

What is the Sigma Sterilization Pouch & Roll designed to protect during sterilization, and how is it used in clinical settings?

The Sigma Sterilization Pouch & Roll is specifically designed to package medical instruments and supplies before sterilization. It uses a medical-grade plastic film with a self-sealing adhesive strip to create a secure barrier that maintains sterility. The pouch is supplied in roll form, making it convenient for clinical settings where bulk packaging is needed, such as hospitals or surgical centers.

Is the Sigma Sterilization Pouch & Roll intended for reuse, or is it meant to be used only once?

The Sigma Sterilization Pouch & Roll is explicitly intended for single-use applications only. This ensures that each pouch provides a fresh, uncontaminated barrier for sterilization, reducing the risk of cross-contamination between procedures.

What materials make up the release paper inside the pouch, and why does this matter for sterilization?

The release paper inside the pouch consists of a laminated structure of polyethylene/paper/polyethylene. This design ensures durability and proper sealing during sterilization processes (e.g., autoclave or ethylene oxide), while also preventing the adhesive from sticking prematurely to instruments or supplies.

How is the pouch secured to maintain sterility, and what makes the adhesive reliable for this purpose?

The pouch features a self-sealing adhesive strip on one side of the medical-grade plastic film, which creates an airtight and watertight seal when applied. This adhesive is designed to adhere securely to itself (when folded or sealed) while remaining non-adhesive to the contents inside, ensuring sterility is maintained until the pouch is opened for use.

What regulatory pathway was followed for FDA clearance of this product, and what does that mean for its use in the U.S.?

The Sigma Sterilization Pouch & Roll received FDA 510(k) clearance under the *Traditional* review pathway, with a decision classification of *Substantially Equivalent* to a predicate device. This means the product was evaluated by the FDA as meeting established safety and effectiveness standards for sterilization pouches, allowing it to be legally marketed and used in the United States for its intended purpose.

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: PDF 510 (K) Summary For SIGMA Sterilization Pouch and Roll, SIGMA Sterilization Pouch and Roll (K180661) - FDA 510 (k), K202462 FDA 510 (k) - SIGMA Sterilization Pouch and Roll, Medical Sterilization Packaging

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Sigma Medical Supplies Corp.

Sources (1)

  • FDA 510(k) K102158 24 fields · synced Sep 19, 2026