STERILIZATION POUCH/ROLL MADE WITH TYVEK

K133838 · Sigma Medical Supplies Corp. · FRG · Mar 11, 2015 · General Hospital

Device Facts

• Record ID: K133838
• Device Name: STERILIZATION POUCH/ROLL MADE WITH TYVEK
• Applicant: Sigma Medical Supplies Corp.
• Product Code: FRG · General Hospital
• Decision Date: Mar 11, 2015
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.6850
• Device Class: Class 2

Intended Use

The Sterilization Pouch/Roll Made with Tyvek® are intended to provide health care workers with an effective method to enclose devices intended for sterilization in the STERRAD® 100S Sterilizer. The device is intended to allow sterilization of enclosed devices and also to maintain sterility of the enclosed devices until used up to 3 years post sterilization. The pouches and rolls are printed with a chemical indicator bar which is a process indicator (ISO 11140-1:2005) that changes from red to blue (or lighter) when exposed to hydrogen peroxide vapor during processing in the STERRAD® Sterilization System.

Device Story

Sterilization pouches and rolls designed to enclose medical devices for terminal sterilization in STERRAD® 100S Gas Plasma Sterilizers. Constructed from medical-grade plastic film and Tyvek®; features integrated chemical indicator ink (red-to-blue color change) to verify exposure to hydrogen peroxide vapor. Available in self-sealing pouches, flat pouches, gusseted pouches, flat rolls, and gusseted rolls. Used by healthcare workers in clinical settings to package instruments; devices are inserted, sealed (via adhesive strip or heat-sealing), and processed. Output is a sterile-packaged instrument; indicator provides visual confirmation of sterilant exposure. Benefits include effective sterilization, maintenance of sterile barrier, and convenient packaging for various device sizes.

Clinical Evidence

Bench testing only. Validated per AAMI/ANSI/ISO 11607-1:2006 and ISO 11140-1:2005. Testing included sterilant penetration (SAL 10^-6), biocompatibility (ISO 10993-10), package integrity (ASTM F88, F1140, F1929), and chemical indicator efficacy. Accelerated aging confirmed 3-year shelf life.

Technological Characteristics

Materials: Tyvek®, PET, PE, n-Heptane adhesive, hydrogen peroxide vapor process indicator ink. Sensing: Chemical indicator (ISO 11140-1:2005). Form factor: Pouches and rolls (flat/gusseted). Sterilization: Gas plasma (STERRAD® 100S, 50°C, 6 min). Standards: ANSI/AAMI/ISO 11607-1:2006.

Indications for Use

Indicated for healthcare workers to enclose medical devices for terminal sterilization in STERRAD® 100S Sterilizers and maintain sterility for up to 3 years post-sterilization.

Regulatory Classification

Identification

A sterilization wrap (pack, sterilization wrapper, bag, or accessories, is a device intended to be used to enclose another medical device that is to be sterilized by a health care provider. It is intended to allow sterilization of the enclosed medical device and also to maintain sterility of the enclosed device until used.

Predicate Devices

• Tyvek® Pouch/Roll with STERRAD® Chemical Indicator (K103210)

Submission Summary (Full Text)

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three human profiles incorporated into its design. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

March 11, 2015

Sigma Medical Supplies Corp. Mr. Uta Shih Official Correspondent C/O Sen Mu Technology Co., Ltd 15-2, Ln 26, Mineyuan 1st Rd, Lingya District Kaohsiung, 802, Taiwan (R.O.C)

Re: K133838 Trade/Device Name: Sterilization Pouch/Roll Made with Tyvek® (Type: Self-sealing sterilization pouches; Sterilization Pouches, Flat; Sterilization Pouches, Gusseted; Sterilization Rolls, Flat; Sterilization Rolls, Gusseted) Regulation Number: 21 CFR 880.6850 Regulation Name: Sterilization Wrap Regulatory Class: II Product Code: FRG Dated: January 27, 2015 Received: February 9, 2015

Dear Mr. Shih:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you; however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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Page 2 - Mr. Shih

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Tejashri Purohit-Sheth, M.D.

Tejashri Purohit-Sheth, M.D. Clinical Deputy Director DAGRID/ODE/CDRH FOR

Erin I. Keith, M.S. Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

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# Indications for use

510(k) Number: K133838

Device Name: Sterilization Pouch/Roll Made with Tyvek® (Type: Self-sealing sterilization pouches; Sterilization Pouches, Flat; Sterilization Pouches, Gusseted; Sterilization Rolls, Flat; Sterilization Rolls, Gusseted)

Indications for Use:

The Sterilization Pouch/Roll Made with Tyvek® are intended to provide health care workers with an effective method to enclose devices intended for sterilization in the STERRAD® 100S Sterilizer. The device is intended to allow sterilization of enclosed devices and also to maintain sterility of the enclosed devices until used up to 3 years post sterilization.

The pouches and rolls are printed with a chemical indicator bar which is a process indicator (ISO 11140-1:2005) that changes from red to blue (or lighter) when exposed to hydrogen peroxide vapor during processing in the STERRAD® Sterilization System.

The Sterilization Pouch/Roll Made with Tyvek® is offered in the follow 5 types:

- O Self-sealing sterilization pouches
- Sterilization pouches, Flat
- Sterilization pouches, Gusseted
- 0 Sterilization rolls, Flat
- Sterilization rolls, Gusseted

Prescription Use AND/OR (Per 21 CFR 801 Subpart D)

Over-The-Counter Use × (Per 21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

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The following table (Table 4-1) lists the model numbers of the Sterilization Pouch/Roll Made with Tyvek® by type, model, dimensions and characteristics:

| Type | Model | Dimensions (mm) | Characteristics |
|------------------------------------------|------------|------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Self-sealing<br>Sterilization<br>Pouches | TYSE057133 | 57mmx133mm | These pouches are made from a medical<br>grade plastic film that is heat sealed on three<br>sides. The forth side has an adhesive strip<br>that is Tyvek® and used to seal the pouch.<br>Release Tyvek® used in the pouch is a<br>laminated sheet with composing structure of<br>Tyvek®, PET, PE. It is a strip to cover the<br>adhesive area and is released before seal the<br>pouch. The Tyvek® conforms to recognized<br>material standards and can be sterilized by<br>Gas plasma. The Process Indicators Ink<br>printed on the Tyvek® will exhibit a color<br>change after the pouch is exposed to Gas<br>plasma. |
| | TYSE090162 | 90mmx162mm | |
| | TYSE070257 | 70mmx257mm | |
| | TYSE090257 | 90mmx257mm | |
| | TYSE135283 | 135mmx283mm | |
| | TYSE135335 | 135mmx335mm | |
| | TYSE190358 | 190mmx358mm | |
| | TYSE300380 | 300mmx380mm | |
| | TYSE300474 | 300mmx474mm | |
| Sterilization<br>Pouches, Flat | TYFP075200 | 75mmx200mm | These pouches has the same<br>components with the Self-sealing<br>sterilization pouches, except the forth<br>side is left opened instead of an<br>adhesive strip and will be heat-sealed<br>when using. |
| | TYFP075300 | 75mmx300mm | |
| | TYFP100200 | 100mmx200mm | |
| | TYFP100300 | 100mmx300mm | |
| | TYFP150300 | 150mmx300mm | |
| | TYFP200400 | 200mmx400mm | |
| | TYFP250450 | 250mmx450mm | |
| | TYFP300500 | 300mmx500mm | |
| Sterilization<br>Pouches,<br>Gusseted | TYGP100300 | 100mmx40mmx300mm | These rolls are the same with the<br>Sterilization pouches, flat, except that<br>the plastic film is folded on both<br>longest sides instead of flat. This<br>design is convenient to enclose the<br>medical devices with certain height. |
| | TYGP150400 | 150mmx50mmx400mm | |
| | TYGP200400 | 200mmx50mmx400mm | |
| | TYGP250480 | 250mmx60mmx480mm | |
| | TYGP300500 | 300mmx70mmx500mm | |
| Type | Model | Dimensions (mm) | Characteristics |
| Sterilization<br>Rolls, Flat | TYFR050070 | 50mmx70M | These rolls are made from a Tyvek®<br>and plastic film that are heat-sealed<br>on opposite two sides. It will be cut<br>into the suitable length and the<br>opened sides will be heat-sealed. The<br>indicators printed on the Tyvek® are<br>the same with the self-sealing<br>sterilization pouches. |
| | TYFR075070 | 75mmx70M | |
| | TYFR100070 | 100mmx70M | |
| | TYFR150070 | 150mmx70M | |
| | TYFR200070 | 200mmx70M | |
| | TYFR250070 | 250mmx70M | |
| | TYFR300070 | 300mmx70M | |
| | TYFR350070 | 350mmx70M | |
| | TYFR400070 | 400mmx70M | |
| | TYFR450070 | 450mmx70M | |
| | TYFR500070 | 500mmx70M | |
| | TYFR050100 | 50mmx100M | |
| | TYFR075100 | 75mmx100M | |
| | TYFR100100 | 100mmx100M | |
| | TYFR150100 | 150mmx100M | |
| | TYFR200100 | 200mmx100M | |
| | TYFR250100 | 250mmx100M | |
| | TYFR300100 | 300mmx100M | |
| | TYFR350100 | 350mmx100M | |
| | TYFR400100 | 400mmx100M | |
| | TYFR450100 | 450mmx100M | |
| | TYFR500100 | 500mmx100M | |
| | TYFR050200 | 50mmx200M | |
| | TYFR075200 | 75mmx200M | |
| | TYFR100200 | 100mmx200M | |
| | TYFR150200 | 150mmx200M | |
| | TYFR200200 | 200mmx200M | |
| | TYFR250200 | 250mmx200M | |
| | TYFR300200 | 300mmx200M | |
| | TYFR350200 | 350mmx200M | |
| | TYFR400200 | 400mmx200M | |
| Sterilization<br>Rolls, Gusseted | TYGR075100 | 75mmx35mmx100M | These rolls are the same with the flat<br>sterilization roll, except that the<br>plastic film is folded on both longest<br>sides instead of flat. This design is<br>convenient to enclose the medical<br>devices with certain height. |
| | TYGR100100 | 100mmx40mmx100M | |
| | TYGR150100 | 150mmx50mmx100M | |
| | TYGR200100 | 200mmx50mmx100M | |
| | TYGR250100 | 250mmx60mmx100M | |
| | TYGR300100 | 300mmx70mmx100M | |
| | TYGR350100 | 350mmx80mmx100M | |
| | TYGR400100 | 400mmx80mmx100M | |

Table 4-1. The model numbers of Sterilization Pouch/Roll Made with Tyvek® (Type, Model, Dimension and Characteristics)

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# 510(K) Summary

| 5.0 Prepared Date: | March 11, 2015. |
|----------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 5.1 Device Trade Name: | Sterilization Pouch/Roll Made with Tyvek®<br>(Type: Self-sealing sterilization pouches; Sterilization Pouches, Flat; Sterilization Pouches, Gusseted; Sterilization Rolls, Flat; Sterilization Rolls, Gusseted) |
| 5.2 Named and Address of Manufacturer: | Sigma Medical Supplies Corporation<br>NO.34, Ding-Ping Road, Ruei Fang Industrial Park<br>Ruei Fang Dist., New Taipei City 224, Taiwan, R.O.C |
| Establishment Registration Number: | 3004970050 |
| Contact Person: | Rose Chien<br>Quality Assurance / Regulatory Affairs Manager<br>Tel: [phone] ext. 283<br>Fax: [phone]<br>E-mail: [e-mail] |
| 5.3 Device Classification Names: | 1) Sterilization wrap containers, trays, cassettes & accessories.<br>2) Indicator, Physical/Chemical Sterilization Process |
| Classification/Panel: | Class II, 21CFR 880.6850 |
| Classification Advisory Committee: | General Hospital |
| Product Code: | FRG |
| Recognized Performance Standard: | ANSI/AAMI/ISO 11607-1:2006 (FRG) |

### 5.4 Predicate Devices:

K103210, Tyvek® Pouch/Roll with STERRAD® Chemical Indicator (FRG)

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### 5.5 Intended Use

The Sterilization Pouch/Roll Made with Tyvek® are intended to provide health care workers with an effective method to enclose devices intended for sterilization in the STERRAD® 100S Sterilizer. The device is intended to allow sterilization of enclosed devices and also to maintain sterility of the enclosed devices until used up to 3 years post sterilization.

The pouches and rolls are printed with a chemical indicator bar which is a process indicator (ISO 11140-1:2005) that changes from red to blue (or lighter) when exposed to hydrogen peroxide vapor during processing in the STERRAD® Sterilization System.

#### 5.6 Device Description

Sterilization Pouch/Roll Made with Tyvek® is intended to contain medical devices to be terminally sterilized in the STERRAD® Sterilization Systems. The recommended Gas Plasma sterilization cycle parameter is 6 minutes (Injection volume: 2880µ L) at 50°C. The medical devices are inserted into the Pouch/Roll, sealed, and then sterilized in the STERRAD® Sterilization System. After completion of the sterilization process, the Pouch/Roll maintain sterility of the enclosed medical devices until the seal is opened. The device is intended to allow sterilization of enclosed devices and also to maintain sterility of the enclosed devices until used up to 3 years post sterilization.

The Pouch/Roll is printed with a chemical indicator bar that changes from red to blue (or lighter) when exposed to hydrogen peroxide vapor during processing in the STERRAD® Sterilization System.

The proposed pouches are constructed from Tyvek® plastic films, with H2O2 Chemical Indicator printed onto the Tyvek" film. The Self-seal pouch permits sealing of the pouch without need of heat- sealing equipment, while the heat sealed pouches and rolls are heat sealed prior to processing in the STERRAD® Sterilization Systems.

The H2O2 Chemical Indicator offers an addition way to verity processing in the sterilization cycle. The Chemical Indicator should be used in addition to, not in place of, the biological indicator. H2O2 Chemical Indicators do not signify sterilization; they only indicate that the indicator has been exposed to the hydrogen peroxide. The color of the Chemical Indicator changes from red to blue (or lighter) when exposed to hydrogen peroxide.

The Sterilization Pouch/Roll Made with Tyvek® is offered in the follow 5 types:

- Self-sealing sterilization pouches .
- . Sterilization pouches, Flat
- . Sterilization pouches, Gusseted
- Sterilization rolls, Flat
- Sterilization rolls, Gusseted

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The defining characteristics of the 5 types as follows:

- · Self-sealing sterilization pouches: These pouches are made from a medical grade plastic film that is heat sealed on three sides. The forth side has an adhesive strip that is Tyvek® and used to seal the pouch. Release Tyvek® used in the pouch is a laminated sheet with composing structure of Tyvek®, PET, PE. It is a strip to cover the adhesive area and is released before seal the pouch. The Tyvek" conforms to recognized material standards and can be sterilized by Gas plasma. The Process Indicators Ink printed on the Tyvek® will exhibit a color change after the pouch is exposed to Gas plasma.
- . Sterilization pouches, Flat: These pouches has the same components with the Selfsealing sterilization pouches, except the forth side is left opened instead of an adhesive strip and will be heat-sealed when using.
- · Sterilization pouches, Gusseted: These rolls are the same with the Sterilization pouches, flat, except that the plastic film is folded on both longest sides instead of flat. This design is convenient to enclose the medical devices with certain height.
- · Sterilization rolls. Flat: These rolls are made from a Tyvek® and plastic film that are heat sealed on opposite two sides. It will be cut into the suitable length and the opened sides will be heat-sealed. The indicators printed on the Tyvek" are the same with the self-sealing sterilization pouches.
- . Sterilization rolls, Gusseted: These rolls are the same with the flat sterilization roll, except that the plastic film is folded on both longest sides instead of flat. This design is convenient to enclose the medical devices with certain height.

The following table (Table 5-1) lists the model numbers of the Sterilization Pouch/Roll Made with Tyvek® by type, model, dimensions:

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| Table 5-1. The model numbers of Sterilization Pouch/Roll Made with Tyvek |
|--------------------------------------------------------------------------|
| (Type, Model and Dimension) |

| Type | Model | Dimensions (mm) |
|------------------------------------|------------|------------------|
| Self-sealing Sterilization Pouches | TYSE057133 | 57mmx133mm |
| | TYSE090162 | 90mmx162mm |
| | TYSE070257 | 70mmx257mm |
| | TYSE090257 | 90mmx257mm |
| | TYSE135283 | 135mmx283mm |
| | TYSE135335 | 135mmx335mm |
| | TYSE190358 | 190mmx358mm |
| | TYSE300380 | 300mmx380mm |
| | TYSE300474 | 300mmx474mm |
| Sterilization Pouches, Flat | TYFP075200 | 75mmx200mm |
| | TYFP075300 | 75mmx300mm |
| | TYFP100200 | 100mmx200mm |
| | TYFP100300 | 100mmx300mm |
| | TYFP150300 | 150mmx300mm |
| | TYFP200400 | 200mmx400mm |
| | TYFP250450 | 250mmx450mm |
| | TYFP300500 | 300mmx500mm |
| | Model | Dimensions (mm) |
| Sterilization Pouches, Gusseted | TYGP100300 | 100mmx40mm300mm |
| | TYGP150400 | 150mmx50mmx400mm |
| | TYGP200400 | 200mmx50mmx400mm |
| | TYGP250480 | 250mmx60mmx480mm |
| | TYGP300500 | 300mmx70mmx500mm |
| Type | Model | Dimensions (mm) |
| Sterilization Rolls, Flat | TYFR050070 | 50mmx70M |
| | TYFR075070 | 75mmx70M |
| | TYFR100070 | 100mmx70M |
| | TYFR150070 | 150mmx70M |
| | TYFR200070 | 200mmx70M |
| | TYFR250070 | 250mmx70M |
| | TYFR300070 | 300mmx70M |
| | TYFR350070 | 350mmx70M |
| | TYFR400070 | 400mmx70M |
| | TYFR450070 | 450mmx70M |
| | TYFR500070 | 500mmx70M |
| | TYFR050100 | 50mmx100M |
| | TYFR075100 | 75mmx100M |
| | TYFR100100 | 100mmx100M |
| | TYFR150100 | 150mmx100M |
| | TYFR200100 | 200mmx100M |
| | TYFR250100 | 250mmx100M |
| | TYFR300100 | 300mmx100M |
| | TYFR350100 | 350mmx100M |
| | TYFR400100 | 400mmx100M |
| | TYFR450100 | 450mmx100M |
| | TYFR500100 | 500mmx100M |
| | TYFR050200 | 50mmx200M |
| | TYFR075200 | 75mmx200M |
| | TYFR100200 | 100mmx200M |
| | TYFR150200 | 150mmx200M |
| | TYFR200200 | 200mmx200M |
| | TYFR250200 | 250mmx200M |
| | TYFR300200 | 300mmx200M |
| | TYFR350200 | 350mmx200M |
| | TYFR400200 | 400mmx200M |
| Type | Model | Dimensions (mm) |
| Sterilization Rolls, Gusseted | TYGR075100 | 75mmx35mmx100M |
| | TYGR100100 | 100mmx40mmx100M |
| | TYGR150100 | 150mmx50mmx100M |
| | TYGR200100 | 200mmx50mmx100M |
| | TYGR250100 | 250mmx60mmx100M |
| | TYGR300100 | 300mmx70mmx100M |
| | TYGR350100 | 350mmx80mmx100M |
| | TYGR400100 | 400mmx80mmx100M |

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### SECTION 5

### 5.7 Description of Comparison and Substantial Equivalence

A summary of the technological characteristics of the device subject of this premarket notification in comparison to those of the predicate devices is included in Table 5-2.

| Table 5-2 Summary of the Proposed and Predicate Devices Technological Characteristics | | | | |
|---------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------|-----------------|
| Device | New Device | Predicate Devices | | |
| Device name | Sterilization Pouch/Roll Made with Tyvek® | Tyvek® Pouch/Roll with STERRAD® Chemical Indicator | | |
| 510(k) number | K133838 | K103210 | | |
| Material<br>Composition | Tyvek®, PET, PE, Water, CH3COOH, Alcohol, n-Heptane adhesive, Hydrogen peroxide vapor Process Indicator Print Ink | Tyvek®, PET, PE, Water, CH3COOH, Alcohol, n-Heptane adhesive, Hydrogen peroxide vapor Process Indicator Print Ink | | |
| Intended use | Sterilization Pouch/Roll Made with Tyvek® are intended to provide health care workers with an effective method to enclose devices intended for sterilization in the STERRAD® 100S Sterilizer. The device is intended to allow sterilization of enclosed devices and also to maintain sterility of the enclosed devices until used up to 3 years post sterilization. The pouches and rolls are printed with a chemical indicator bar which is a process indicator (ISO 11140-1:2005) that changes from red to blue (or lighter) when exposed to hydrogen peroxide vapor during processing in the STERRAD® Sterilization System. | Tyvek® Pouch/Roll with STERRAD® Chemical Indicator are intended to be used to enclose medical devices that are be terminally sterilized in the STERRAD® 100NXTM Sterilizer and to indicate, by color change, that the pouch has exposed to sterilant. After completion of sterilization process, the Pouch/Roll maintain sterility until the seal of the Pouch/Roll is opened. The pouches and rolls are printed with a chemical indicator bar which is a process indicator (ISO 11140-1:2005) that changes from red to yellow (or lighter) when exposed to hydrogen peroxide vapor processing in the STERRAD® Sterilization Systems. | | |
| Device models<br>(Configurations/Dimensions) | Self-sealing Sterilization Pouches | Tyvek® Pouch with STERRAD® Chemical Indicator, Self Seal, | | |
| | Model | Dimensions (mm) | Model (Code) | Dimensions (mm) |
| | TYSE057133 | 57mmx133mm | 12320 | 76mm x 203 mm |
| | TYSE090162 | 90mmx162mm | 12326 | 102mm x 260 mm |
| | TYSE070257 | 70mmx257mm | 12332 | 152mm x 318 mm |
| | TYSE090257 | 90mmx257mm…