SterileRight sterilization pouch and roll

K212338 · Sterileright Packaging Mfg., Inc. · FRG · Nov 1, 2021 · General Hospital

Device Facts

• Record ID: K212338
• Device Name: SterileRight sterilization pouch and roll
• Applicant: Sterileright Packaging Mfg., Inc.
• Product Code: FRG · General Hospital
• Decision Date: Nov 1, 2021
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.6850
• Device Class: Class 2

Intended Use

The SterileRight Sterilization Pouch and Roll are intended to provide health care workers with an effective method to enclose devices intended for sterilization in the Steam or via Ethylene Oxide (EO). The recommended sterilization cycles are as follows: - · Gravity steam at 121°C (250°F) for 30 minutes; Drying time of 25 minutes. - · Pre-vacuum steam at 132°C (270°F) for 4 minutes; Drying time of 20 minutes. - · Ethylene Oxide (EO) with a concentration of 735 mg/L at 55°C (131°F) and 50% to 80% relative humidity for 60 minutes. Aeration time of 8 hours at 60°C (140°F). The SterileRight provides the sterilization pouch and roll made with Paper/Film or Tyvek®/Film. The SterileRight sterilization pouch and roll which are made with Paper maintains the sterility of the enclosed devices for up to 6 months post Steam or EO gas sterilization, and before sterilization has a maximum shelf life of 3 years from the date of manufacture. The pouch's external chemical ink indicators are designed to indicate to the user that the pouch has undergone either a steam or EO sterilization process. The SterileRight sterilization pouch and roll which are made with Tyvek® is for EO gas sterilization only. It also maintains the sterility of the enclosed devices for up to 6 months post EO gas sterilization, and before sterilization has a maximum shelf life of 3 years from the date of manufacture.

Device Story

Sterilization packaging system consisting of pouches and rolls; materials include medical-grade paper/film or Tyvek®/film. Used by healthcare workers to enclose medical devices prior to steam or EO sterilization. Features external chemical ink indicators (Steam: Pink to Brown/Black; EO: Blue to Yellow/Brown) to verify exposure to sterilization process. Self-seal variants include adhesive strips; others heat-sealed. Maintains sterility of enclosed devices for up to 6 months post-sterilization. Provides physical barrier to maintain sterility; protects contents during storage and handling. Benefits include effective containment and visual confirmation of sterilization exposure.

Clinical Evidence

Bench testing only. Validation studies included sterilant penetration (SAL 10^-6), drying time, aeration, biocompatibility (ISO 10993-10), and package integrity (ASTM F2251, F1140, F1929, F88, F1886, F2096, DIN 58953-6). Chemical indicator efficacy tested per ISO 11140-1. Accelerated aging confirmed 3-year shelf life and 6-month post-sterilization sterility maintenance.

Technological Characteristics

Materials: Medical grade paper, CPP, PET, Tyvek®, PE, PU adhesive. Sensing: Chemical indicator ink (Steam: Pink to Brown/Black; EO: Blue to Yellow/Brown). Form factor: Flat rolls, gusseted rolls, self-seal pouches, heat-seal pouches. Connectivity: None. Sterilization: Steam (gravity/pre-vacuum) or EO gas. Standards: ASTM F2251, F1140, F1929, F88, F1886, F2096, ISO 11607-1, ISO 10993-10, ISO 11140-1.

Indications for Use

Indicated for healthcare workers to enclose medical devices for sterilization via steam or ethylene oxide (EO) gas. Paper/film pouches are compatible with steam and EO; Tyvek®/film pouches are for EO only. Maximum validated load is 3.3 lbs (1.49 kg).

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

• SIGMA Sterilization Pouch and Roll (K102158)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: a symbol on the left and the FDA name and title on the right. The symbol on the left is a stylized representation of a human figure, while the text on the right reads "FDA U.S. FOOD & DRUG ADMINISTRATION" in blue letters.

November 1, 2021

SterileRight Packaging Mfg., Inc. % Uta Shih Regulatory Affairs Manager Sen Mu Technology Co., LTD. 15F-2, No.1, Lane 26, Mincyuan 1st Rd., Lingya District Kaohsiung City, 802 Taiwan

Re: K212338

Trade/Device Name: SterileRight sterilization pouch and roll Regulation Number: 21 CFR 880.6850 Regulation Name: Sterilization Wrap Regulatory Class: Class II Product Code: FRG, JOJ Dated: July 28, 2021 Received: August 3, 2021

Dear Uta 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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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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 of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely.

Clarence W. Murray, III, PhD Assistant Director DHT4B: Division of Infection Control and Plastic Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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# Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2023 See PRA Statement below.

510(k) Number (if known) K212338

#### Device Name

SterileRight Sterilization Pouch and Roll

#### Indications for Use (Describe)

The SterileRight Sterilization Pouch and Roll are intended to provide health care workers with an effective method to enclose devices intended for sterilization in the Steam or via Ethylene Oxide (EO). The recommended sterilization cycles are as follows:

- · Gravity steam at 121°C (250°F) for 30 minutes; Drying time of 25 minutes.
- · Pre-vacuum steam at 132°C (270°F) for 4 minutes; Drying time of 20 minutes.
- · Ethylene Oxide (EO) with a concentration of 735 mg/L at 55°C (131°F) and 50% to 80% relative humidity for 60 minutes. Aeration time of 8 hours at 60°C (140°F).

The SterileRight provides the sterilization pouch and roll made with Paper/Film or Tyvek®/Film.

The SterileRight sterilization pouch and roll which are made with Paper maintains the sterility of the enclosed devices for up to 6 months post Steam or EO gas sterilization, and before sterilization has a maximum shelf life of 3 years from the date of manufacture. The pouch's external chemical ink indicators are designed to indicate to the user that the pouch has undergone either a steam or EO sterilization process.

The SterileRight sterilization pouch and roll which are made with Tyvek® is for EO gas sterilization only. It also maintains the sterility of the enclosed devices for up to 6 months post EO gas sterilization, and before sterilization has a maximum shelf life of 3 years from the date of manufacture.

Type of Use (Select one or both, as applicable)

Prescription Use (Part 21 CFR 801 Subpart D)

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

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| Type | Size | Model |
|-------------------------------------------|-------------------------------------|-------|
| Paper/Film Sterilization Flat Roll | W: 50mm ~ 400mm<br>L: ~ 200M | P01 |
| Paper/Film Sterilization Gusseted Roll | W: 75mm ~ 400mm<br>L: ~ 100M | P02 |
| Paper/Film Self-seal Sterilization Pouch | W: 57mm ~ 300mm<br>L: 133mm ~ 474mm | P03 |
| Paper/Film Sterilization Pouch | W: 50mm ~ 400mm<br>L: 100mm ~ 600mm | P04 |
| Tyvek®/Film Sterilization Flat Roll | W: 50mm ~ 400mm<br>L: ~ 200M | T01 |
| Tyvek®/Film Sterilization Gusseted Roll | W: 75mm ~ 400mm<br>L: ~ 100M | T02 |
| Tyvek®/Film Self-seal Sterilization Pouch | W: 57mm ~ 300mm<br>L: 133mm ~ 474mm | T03 |
| Tyvek®/Film Sterilization Pouch | W: 50mm ~ 400mm<br>L: 100mm ~ 600mm | T04 |

The maximum validated pouch load is 3.3 pounds (1.49 kg).

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# 510 (k) Summary for K212338

# Submitter's Information

| Name: | Sterileright Packaging Mfg., Inc. |
|----------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------|
| Address: | 1F, No.33-7, Dahua 2nd Rd., Qidu Dist., Keelung<br>City 206,Taiwan |
| Establishment<br>Registration Number: | 1st submission |
| Contact: | Laney Huang<br>Sales Director<br>Factory: [phone]<br>Office: [phone]<br>email: [e-mail] |
| | Or<br>Thomas Chou<br>RD Director<br>Factory: [phone]<br>Office: [phone]<br>email: [e-mail] |
| Date Prepared: | July 22, 2021 |
| Device Name | |
| Trade Name:<br>Common/usual Name: | SterileRight Sterilization Pouch and Roll<br>SterileRight Sterilization Pouch and Roll |
| Device Classification Names: | 1) Wrap, Sterilization.<br>2) Indicator, Physical/Chemical Sterilization Pro-<br>cess |
| Panel: | General Hospital |
| Classification Product Code:<br>Subsequent Product Code: | 1) FRG<br>2) JOJ |

Device Classification: Class II Regulation Number: 1) 21 CFR 880.6850 2) 21 CFR 880.2800

## Predicate Devices

The predicate device [510(k) Notification K102158, cleared August 02, 2011] is the SIGMA Sterilization Pouch and Roll.

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# Indications for Use

The SterileRight Sterilization Pouch and Roll are intended to provide health care workers with an effective method to enclose devices intended for sterilization in the Steam or via Ethylene Oxide (EO). The recommended sterilization cycles are as follows:

- · Gravity steam at 121°C (250°F) for 30 minutes; Drying time of 25 minutes.
- Pre-vacuum steam at 132°C (270°F) for 4 minutes; Drying time of 20 minutes.
- · Ethylene Oxide (EO) with a concentration of 735 mg/L at 55°C (131°F) and 50% to 80% relative humidity for 60 minutes. Aeration time of 8 hours at 60°C (140°F).

The SterileRight provide sterilization pouch and roll made with Paper/Film or Tyvek® /Film.

The SterileRight sterilization pouch and roll which are made with Paper maintains the sterility of the enclosed devices for up to 6 months post Steam or EO gas sterilization, and before sterilization has a maximum shelf life of 3 years from the date of manufacture. The pouch's external chemical ink indicators are designed to indicate to the user that the pouch has undergone either a steam or EO sterilization process.

The SterileRight sterilization pouch and roll which are made with Tvyek® is for EO gas sterilization only. It also maintains the sterility of the enclosed devices for up to 6 months post EO gas sterilization, and before sterilization has a maximum shelf life of 3 years from the date of manufacture.

The SterileRight sterilization pouch and roll is offered 8 types in the following:

- · Paper/Film Sterilization Flat Roll
- · Paper/Film Sterilization Gusseted Roll
- · Paper/Film Self-seal Sterilization Pouch
- · Paper/Film Sterilization Pouch
- · Tyvek® /Film Sterilization Flat Roll
- · Tyvek® /Film Sterilization Gusseted Roll
- · Tyvek® /Film Self-seal Sterilization Pouch
- · Tyvek® /Film Sterilization Pouch

The following table (Table 1) lists the model numbers of the SterileRight sterilization pouch and roll by type, model, dimensions, and content/max. load (lbs.):

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| Type | Description | Model | Dimension | Content / Max Load (lbs.) | | |
|------|-----------------------------------------------------------------------------------------|---------------|---------------|---------------------------|---------|-------------------|
| | | | | Metal | Plastic | Gauze / Linens |
| P01 | Paper/Film Sterilization Flat Roll<br>(with EO, Steam Indicators) | P01-050030 | 50mm x 30m | 0.04 | 0.03 | 0.01 |
| | | P01-075030 | 75mm x 30m | 0.06 | 0.05 | 0.02 |
| | | P01-100030 | 100mm x 30m | 0.22 | 0.19 | 0.09 |
| | | P01-150030 | 150mm x 30m | 0.40 | 0.35 | 0.18 |
| | | P01-200030 | 200mm x 30m | 0.63 | 0.57 | 0.28 |
| | | P01-250030 | 250mm x 30m | 2.22 | 2.08 | 1.04 |
| | | P01-300030 | 300mm x 30m | 2.64 | 2.64 | 1.32 |
| | | P01-350030 | 350mm x 30m | 2.64 | 2.64 | 1.32 |
| | | P01-400030 | 400mm x 30m | 2.64 | 2.64 | 1.32 |
| | | P01-050200 | 50mm x 200m | 0.04 | 0.03 | 0.01 |
| | | P01-075200 | 75mm x 200m | 0.06 | 0.05 | 0.02 |
| | | P01-100200 | 100mm x 200m | 0.22 | 0.19 | 0.09 |
| | | P01-150200 | 150mm x 200m | 0.40 | 0.35 | 0.18 |
| | | P01-200200 | 200mm x 200m | 0.63 | 0.57 | 0.28 |
| | | P01-250200 | 250mm x 200m | 2.22 | 2.08 | 1.04 |
| | | P01-300200 | 300mm x 200m | 2.64 | 2.64 | 1.32 |
| | | P01-350200 | 350mm x 200m | 2.64 | 2.64 | 1.32 |
| | | P01-400200 | 400mm x 200m | 2.64 | 2.64 | 1.32 |
| P02 | Paper/Film Sterilization Gusseted Roll<br>(with EO, Steam Indicators) | P02-075030 | 75mm x 30m | 0.08 | 0.06 | 0.03 |
| | | P02-100030 | 100mm x 30m | 0.13 | 0.09 | 0.05 |
| | | P02-150030 | 150mm x 30m | 0.67 | 0.43 | 0.22 |
| | | P02-200030 | 200mm x 30m | 1.13 | 0.71 | 0.36 |
| | | P02-250030 | 250mm x 30m | 1.78 | 1.09 | 0.55 |
| | | P02-300030 | 300mm x 30m | 3.30 | 3.30 | 1.65 |
| | | P02-350030 | 350mm x 30m | 3.30 | 3.30 | 1.65 |
| | | P02-400030 | 400mm x 30m | 3.30 | 3.30 | 1.65 |
| | | P02-075100 | 75mm x 100m | 0.08 | 0.06 | 0.03 |
| | | P02-100100 | 100mm x 100m | 0.13 | 0.09 | 0.05 |
| | | P02-150100 | 150mm x 100m | 0.67 | 0.43 | 0.22 |
| | | P02-200100 | 200mm x 100m | 1.13 | 0.71 | 0.36 |
| | | P02-250100 | 250mm x 100m | 1.78 | 1.09 | 0.55 |
| | | P02-300100 | 300mm x 100m | 3.30 | 3.30 | 1.65 |
| | | P02-350100 | 350mm x 100m | 3.30 | 3.30 | 1.65 |
| | | P02-400100 | 400mm x 100m | 3.30 | 3.30 | 1.65 |
| Type | Description | Model | Dimension | Content / Max Load (lbs.) | | |
| | | | | Metal | Plastic | Gauze /<br>Linens |
| P03 | Paper/Film<br>Self-seal Steri-<br>lization Pouch<br>(with EO,<br>Steam Indica-<br>tors) | P03-057133 | 57mm x 133mm | 0.04 | 0.03 | 0.01 |
| | | P03-070257 | 70mm x 257mm | 0.11 | 0.09 | 0.04 |
| | | P03-090162 | 90mm x 162mm | 0.08 | 0.07 | 0.03 |
| | | P03-090257 | 90mm x 257mm | 0.15 | 0.13 | 0.06 |
| | | P03-090594 | 90mm x 594mm | 0.53 | 0.47 | 0.23 |
| | | P03-133391 | 133mmX391mm | 0.50 | 0.45 | 0.22 |
| | | P03-135283 | 135mm x 283mm | 0.31 | 0.27 | 0.14 |
| | | P03-180335 | 180mm x 335mm | 0.64 | 0.57 | 0.29 |
| | | P03-190358 | 190mm x 358mm | 0.78 | 0.70 | 0.35 |
| | | P03-200435 | 200mm x 435mm | 1.18 | 1.08 | 0.54 |
| | | P03-300380 | 300mm x 380mm | 1.88 | 1.76 | 0.88 |
| | | P03-300474 | 300mm x 474mm | 2.64 | 2.63 | 1.32 |
| P04 | Paper/Film<br>Sterilization<br>Pouch (with<br>EO, Steam In-<br>dicators) | P04-050100 | 50mm x 100mm | 0.02 | 0.02 | 0.01 |
| | | P04-075150 | 75mm x 150mm | 0.06 | 0.05 | 0.02 |
| | | P04-075200 | 75mm x 200mm | 0.08 | 0.07 | 0.03 |
| | | P04-100200 | 100mm x 200mm | 0.12 | 0.10 | 0.05 |
| | | P04-100550 | 100mm x 550mm | 0.55 | 0.49 | 0.25 |
| | | P04-120250 | 120mm x 250mm | 0.22 | 0.19 | 0.09 |
| | | P04-120280 | 120mm x 280mm | 0.26 | 0.22 | 0.11 |
| | | P04-150200 | 150mm x 200mm | 0.22 | 0.19 | 0.09 |
| | | P04-150250 | 150mm x 250mm | 0.30 | 0.26 | 0.13 |
| | | P04-150380 | 150mm x 380mm | 0.58 | 0.52 | 0.26 |
| | | P04-150550 | 150mm x 550mm | 1.08 | 0.99 | 0.49 |
| | | P04-180300 | 180mm x 300mm | 0.54 | 0.48 | 0.24 |
| | | P04-200330 | 200mm x 330mm | 0.74 | 0.67 | 0.33 |
| | | P04-200600 | 200mm x 600mm | 2.06 | 1.93 | 0.96 |
| | | P04-205400 | 205mm x 400mm | 1.07 | 0.98 | 0.49 |
| | | P04-250300 | 250mm x 300mm | 0.92 | 0.83 | 0.42 |
| | | P04-300380 | 300mm x 380mm | 1.88 | 1.76 | 0.88 |
| | P04-300460 | 300mm x 460mm | 2.64 | 2.49 | 1.25 | |
| | P04-400600 | 400mm x 600mm | 2.64 | 2.64 | 1.32 | |
| | | | Dimension | Content / Max Load (lbs.) | | |
| Type | Description | Model | | Metal | Plastic | Gauze /<br>Linens |
| T01 | Tyvek®/Film<br>Sterilization Flat<br>Roll | T01-050060 | 50mm x 60m | 0.04 | 0.03 | 0.01 |
| | | T01-075060 | 75mm x 60m | 0.06 | 0.05 | 0.02 |
| | | T01-100060 | 100mm x 60m | 0.22 | 0.19 | 0.09 |
| | | T01-150060 | 150mm x 60m | 0.40 | 0.35 | 0.18 |
| | | T01-200060 | 200mm x 60m | 0.63 | 0.57 | 0.28 |
| | | T01-250060 | 250mm x 60m | 2.22 | 2.08 | 1.04 |
| | | T01-300060 | 300mm x 60m | 2.64 | 2.64 | 1.32 |
| | | T01-350060 | 350mm x 60m | 2.64 | 2.64 | 1.32 |
| | | T01-400060 | 400mm x 60m | 2.64 | 2.64 | 1.32 |
| | | T01-050200 | 50mm x 200m | 0.04 | 0.03 | 0.01 |
| | | T01-075200 | 75mm x 200m | 0.06 | 0.05 | 0.02 |
| | | T01-100200 | 100mm x 200m | 0.22 | 0.19 | 0.09 |
| | | T01-150200 | 150mm x 200m | 0.40 | 0.35 | 0.18 |
| | | T01-200200 | 200mm x 200m | 0.63 | 0.57 | 0.28 |
| | | T01-250200 | 250mm x 200m | 2.22 | 2.08 | 1.04 |
| | | T01-300200 | 300mm x 200m | 2.64 | 2.64 | 1.32 |
| | | T01-350200 | 350mm x 200m | 2.64 | 2.64 | 1.32 |
| | | T01-400200 | 400mm x 200m | 2.64 | 2.64 | 1.32 |
| T02 | Tyvek®/Film<br>Sterilization<br>Gusseted Roll | T02-075030 | 75mm x 30m | 0.08 | 0.06 | 0.03 |
| | | T02-100030 | 100mm x 30m | 0.13 | 0.09 | 0.05 |
| | | T02-150030 | 150mm x 30m | 0.67 | 0.43 | 0.22 |
| | | T02-200030 | 200mm x 30m | 1.13 | 0.71 | 0.36 |
| | | T02-250030 | 250mm x 30m | 1.78 | 1.09 | 0.55 |
| | | T02-300030 | 300mm x 30m | 3.30 | 3.30 | 1.65 |
| | | T02-350030 | 350mm x 30m | 3.30 | 3.30 | 1.65 |
| | | T02-400030 | 400mm x 30m | 3.30 | 3.30 | 1.65 |
| | | T02-075100 | 75mm x 100m | 0.08 | 0.06 | 0.03 |
| | | T02-100100 | 100mm x 100m | 0.13 | 0.09 | 0.05 |
| | | T02-150100 | 150mm x 100m | 0.67 | 0.43 | 0.22 |
| | | T02-200100 | 200mm x 100m | 1.13 | 0.71 | 0.36 |
| | | T02-250100 | 250mm x 100m | 1.78 | 1.09 | 0.55 |
| | | T02-300100 | 300mm x 100m | 3.30 | 3.30 | 1.65 |
| | | T02-350100 | 350mm x 100m | 3.30 | 3.30 | 1.65 |
| | | T02-400100 | 400mm x 100m | 3.30 | 3.30 | 1.65 |
| | | | | | | |
| Type | Description | Model | Dimension | Content / Max Load (lbs.) | | |
| | | | | Metal | Plastic | Gauze /<br>Linens |
| T03 | Tyvek®/Film<br>Self-seal Sterilization Pouch | T03-057133 | 57mm x 133mm | 0.04 | 0.03 | 0.01 |
| | | T03-070257 | 70mm x 257mm | 0.11 | 0.09 | 0.04 |
| | | T03-090162 | 90mm x 162mm | 0.08 | 0.07 | 0.03 |
| | | T03-090257 | 90mm x 257mm | 0.15 | 0.13 | 0.06 |
| | | T03-135283 | 135mm x 283mm | 0.31 | 0.27 | 0.14 |
| | | T03-180335 | 180mm x 335mm | 0.64 | 0.57 | 0.29 |
| | | T03-190358 | 190mm x 358mm | 0.78 | 0.70 | 0.35 |
| | | T03-254408 | 254mm x 408mm | 1.59 | 1.48 | 0.74 |
| | | T03-300380 | 300mm x 380mm | 1.88 | 1.76 | 0.88 |
| | | T03-300474 | 300mm x 474mm | 2.64 | 2.63 | 1.32 |
| T04 | Tyvek®/Film<br>Sterilization Pouch | T04-050100 | 50mm x 100mm | 0.02 | 0.02 | 0.01 |
| | | T04-100200 | 100mm x 200mm | 0.12 | 0.10 | 0.05 |
| | | T04-150255 | 150mm x 255mm | 0.31 | 0.27 | 0.14 |
| | | T04-150380 | 150mm x 380mm | 0.58 | 0.52 | 0.26 |
| | | T04-190330 | 190mm x 330mm | 0.68 | 0.61 | 0.31 |
| | | T04-200330 | 200mm x 330mm | 0.74 | 0.67 | 0.33 |
| | | T04-250300 | 250mm x 300mm | 0.92 | 0.83 | 0.42 |
| | | T04-300380 | 300mm x 380mm | 1.88 | 1.76 | 0.88 |
| | | T04-300460 | 300mm x 460mm | 2.64 | 2.49 | 1.25 |
| | | T04-400600 | 400mm x 600mm | 2.64 | 2.64 | 1.32 |

Table 1. The model numbers of SterileRight sterilization pouch and roll (Type, Model and Dimension and Content/Max. Load)

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Table 1. (Continued) The model numbers of SterileRight sterilization pouch and roll (Type, Model and Dimension and Content/Max. Load)

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Table 1. (Continued) The model numbers of SterileRight sterilization pouch and roll (Type, Model and Dimension and Content/Max. Load)

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Table 1. (Continued) The model numbers of SterileRight sterilization pouch and roll (Type, Model and Dimension and Content/Max. Load)

# Device Descrintion

The medical devices are inserted into the Sterilization Pouch/Roll, sealed, and then sterilized in the Sterilization System. After completion of the sterilization process, the Pouch/Roll maintains the 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 6 months post Steam or EO gas sterilization.

The Self-seal pouch permits the sealing of the pouch without the need of heat-sealing equipment, while the heat-sealed pouches and rolls are heat-sealed prior to processing in the steam/or EO Sterilization.

The chemical indicators ink printed on the "medical grade paper" will exhibit a color change after the pouch is exposed to steam or ethylene oxide gas. The color of the Chemical Indicator changes from Pink to Brown/Black when exposed to Steam. And the color changes from Blue to Yellow/Brown, when exposed to EO gas.

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The Chemical Indicator offers an additional way to verify processing in the sterilization cycle. The Chemical Indicator should be used in addition to, not in place of, the biological indicator. The Chemical Indicators do not signify sterilization; they only indicate that the indicator has been exposed to Steam/or EO gas.

The SterileRight sterilization pouch and roll made with Tyvek® is for EO gas sterilization only. It also maintains the sterility of the enclosed devices for up to 6 months post EO gas sterilization.

## Description of Technological Characteristics Comparison

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 2.

| Feature | Proposed device | | Predicate device | Comparison | |
|------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device<br>name | SterileRight sterilization pouch and roll | | SIGMA sterilization pouch and roll<br>(K102158) | | |
| Material<br>Composi-<br>tion | Medical Grade Paper, CPP, PET, adhesive, EO and Steam Process Indicator, Print Ink. Tyvek®, PET, PE, adhesive. | | Medical Grade Paper, CPP, PET, PU adhesive, EO and Steam Process Indicator, Print Ink. | Similar | The Pro-<br>posed de-<br>vice pro-<br>vides extra<br>Tyvek®<br>material. |
| Intended<br>use | The SterileRight Sterilization Pouch and Roll are<br>intended to provide health care workers with an ef-<br>fective method to enclose devices intended for ster-<br>ilization in the Steam or via Ethylene Oxide (EO).<br>The recommended sterilization cycles are as fol-<br>lows:<br>•Gravity steam at 121°C (250°F) for 30 minutes;<br>Drying time of 25 minutes.<br>•Pre-vacuum steam at 132°C (270°F) for 4<br>minutes; Drying time of 20 minutes.<br>•Ethylene Oxide (EO) with a concentration of 735<br>mg/L at 55°C (131°F) and 50% to 80% relative<br>humidity for 60 minutes. Aeration time of 8 hours<br>at 60°C (140°F).<br>The SterileRight provides the sterilization pouch<br>and roll made with Paper/Film or Tyvek® /Film.<br>The SterileRight sterilization pouch and roll which<br>are made with Paper maintains the sterility of the<br>enclosed devices for up to 6 months post Steam or<br>EO gas sterilization, and before sterilization has a<br>maximum shelf life of 3 years from the date of<br>manufacture. The pouch's external chemical ink in-<br>dicators are designed to indicate to the user that the<br>pouch has undergone either a steam or EO steriliza-<br>tion process.<br>The SterileRight sterilization pouch and roll which<br>are made with Tyvek® is for EO gas sterilization<br>only. It also maintains the sterility of the enclosed<br>devices for up to 6 months post EO gas sterilization,<br>and before sterilization has a maximum shelf life of<br>3 years from the date of manufacture. | | The sterilization pouch and roll are intended<br>to provide health care workers with an effec-<br>tive method to enclose devices intended for<br>sterilization in steam auto claves and via Eth-<br>ylene Oxide (EO). The recommended steam<br>sterilization cycle parameters are 30 minutes<br>at 121°C. The recommended EO sterilization<br>cycle is 4 hours at 55°C with a relative hu-<br>midity between 50%-85% and a sterilant con-<br>centration of 600 mg/L. Furthermore, the ster-<br>ilization pouch and roll maintains the en-<br>closed devices up until 3 years post steriliza-<br>tion. Lastly, the pouch's external chemical<br>ink indicators are designed to indicate to the<br>user that the pouch has undergone either a<br>steam or EO sterilization process. | Similar | The Steam<br>sterilization<br>of the pro-<br>posed de-<br>vice in-<br>crease by<br>one cycle<br>(Pre-vac-<br>uum 132°C/<br>4 min).<br>The param-<br>eters of EO<br>gas sterili-<br>zation are<br>similar. |

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| Feature | Proposed device: SterileRight sterilization pouch and roll | | | Predicate device: SIGMA sterilization pouch and roll (K102158) | | Comparison | Note | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
|----------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|--|--------------------------------------------------------------------------------------------------------------------------------------------------------|--|------------|-------------------------------------------------------------------------------------|--|--|-----|--|-----------|----------------------------------------------|--|--|--|--|--|--|--|--|--|--|--|--|--|--|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|---------------------------------------------|--|--|--|--|--|--|
| Pouch<br>Types | Paper/Film Sterilization Flat Roll Paper/Film Sterilization Gusseted Roll Paper/Film Self-seal Sterilization Pouch Paper/Film Sterilization Pouch Tyvek® /Film Sterilization Flat Roll Tyvek® /Film Sterilization Gusseted Roll Tyvek® /Film Self-seal Sterilization Pouch Tyvek® /Film Sterilization Pouch | | | Self-sealing sterilization pouches Sterilization pouches, Flat Sterilization pouches, Gusseted Sterilization rolls, Flat Sterilization rolls, Gusseted | | Similar | The Proposed device provides extra types Tyvek® /Film Sterilization pouch and roll. | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Device<br>models<br>(Configu-<br>ra-<br>tions/Di-<br>mensions) | Paper/Film Sterilization Flat Roll Size Model W: 50mm ~ 400mm<br>L: ~ 200M P01 Paper/Film Sterilization Gusseted Roll Size Model W: 75mm ~ 400mm<br>L: ~ 100M P02 Paper/Film Self-seal Sterilization Pouch Size Model W: 57mm ~ 300mm<br>L: 133mm ~ 474mm P03 Paper/Film Sterilization Pouch Size Model W: 50mm ~ 400mm<br>L: 100mm ~ 600mm P04 | | | | | | | | | | | | | | | | | | | | | | | | | | | Sterilization rolls, Flat Size Model W: 50 mm ~ 400 mm<br>L: ~ 200 M SMFR Sterilization rolls, Gusseted Size Model W: 75 mm ~ 400 mm<br>L: ~ 100M<br>H: 35 mm ~ 80 mm SMGR Self-Sealing Sterilization Pouches Size Model W: 57 mm ~ 300 mm<br>L: 133 mm ~ 474 mm SMSE Sterilization Pouches, Flat Size Model W: 75 mm ~ 300 mm<br>L: 200 mm ~ 500 mm SMFP Sterilization Pouches Gusseted Size Model W: 100 mm ~ 300 mm<br>L: 30 mm ~ 500 mm<br>H:40 mm ~ 70 mm SMGP | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | Same Similar Same Similar Different | | | | | | |
| | N/A | | | | | | The Predicate device provides one extra type. | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| | Tyvek® /Film Sterilization Flat Roll Size Model W: 50mm ~ 400mm<br>L: ~ 200M T01 | | | | | | | | | N/A | | Different | The Proposed device provides one extra type. | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| | Tyvek® /Film Sterilization Gusseted Roll Size Model W: 75mm ~ 400mm<br>L: ~ 100M T02 | | | | | | | | | N/A | | Different | The Proposed device provides one extra type. | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| | Tyvek® /Film Self-seal Sterilization Pouch Size Model W: 57mm ~ 300mm<br>L: 133mm ~ 474mm T03 | | | | | | | | | N/A | | Different | The Proposed device provides one extra type. | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| | Tyvek® /Film Sterilization Pouch Size Model W: 50mm ~ 400mm<br>L: 100mm ~ 600mm T04 | | | | | | | | | N/A | | Different | The Proposed device provides one extra type. | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |

Table 2. (Continued) Summary of the Proposed and Predicate Devices Technological Characteristics

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| Feature | Proposed Device: | Predicate device: | Comparison | Note |
|---------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------|--------------------------------------------------------------------------------------------------------------------------|
| | SterileRight sterilization pouch and roll | SIGMA sterilization pouch and roll<br>(K102158)…