Sterilization Pouch/Roll

K251347 · Sterivic Medical Co., Ltd. · FRG · Jan 28, 2026 · General Hospital

Device Facts

• Record ID: K251347
• Device Name: Sterilization Pouch/Roll
• Applicant: Sterivic Medical Co., Ltd.
• Product Code: FRG · General Hospital
• Decision Date: Jan 28, 2026
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.6850
• Device Class: Class 2

Intended Use

The Sterilization Pouch/Roll is 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: • Steam Sterilization at 132°C (270°F) for 4 minutes; Drying time of 20 minutes. • Ethylene Oxide (EO) with a concentration of 695 mg/L at 50°C (122°F) and 30% to 90% relative humidity for 4 hour. Aeration time of 7 days at room temperature. The Sterilization Pouch/Roll is made with medical grade paper and medical compound film. The Sterilization Pouch/Roll 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. Sterilization indicator will change color according to the sterilization method (ethylene oxide, steam). Ethylene oxide sterilization indicator color change from Pink before sterilization to Yellow after sterilization. The steam sterilization indicator color change from Blue before sterilization to Black after sterilization. The specification and recommended sterilization load of the device is following: see attached page

Device Story

Sterilization Pouch/Roll contains medical devices for terminal sterilization via Steam or Ethylene Oxide (EO). Composed of medical-grade paper and compound film; features external chemical ink indicators for process verification. Used by healthcare workers in clinical settings. Devices are inserted, sealed (self-seal or heat-seal), and processed. Chemical indicators change color (Pink to Yellow for EO; Blue to Black for Steam) to confirm exposure to sterilant; indicators do not confirm sterility. Maintains sterility of enclosed items for up to 6 months post-sterilization. Benefits include effective containment and sterility maintenance of surgical instruments and medical devices.

Clinical Evidence

No clinical data. Bench testing only. Performance validated via ISO 11135 (EO) and ISO 17665-1 (Steam) achieving SAL 10⁻⁶. Physical testing included seal strength (ASTM F88), burst strength (ASTM F1140), leak testing (ASTM F2096), and microbial barrier (ASTM F1608). Biocompatibility confirmed per ISO 10993.

Technological Characteristics

Materials: Medical grade paper (60g/m²), medical compound film (50μm), PU adhesive, and process indicator ink. Dimensions: Various sizes (pouches/rolls). Sterilization: Steam (132°C) and EO (695 mg/L). Connectivity: None. Software: None. Standards: ISO 10993 (biocompatibility), ISO 11135 (EO), ISO 17665-1 (Steam), ASTM F88 (seal strength), ASTM F1140 (burst), ASTM F2096 (leak), ASTM F1608 (microbial barrier).

Indications for Use

Indicated for healthcare workers to enclose medical devices for Steam or Ethylene Oxide (EO) sterilization. Compatible with Steam (132°C/4 min) and EO (695 mg/L, 50°C, 30-90% RH, 4 hr). Maintains sterility for 6 months 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

• Sterilization pouch and roll (K221875)

Reference Devices

• SIGMA Sterilization Pouch and Roll (K180661)

Submission Summary (Full Text)

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FDA U.S. FOOD & DRUG ADMINISTRATION

January 28, 2026

STERIVIC Medical Co., Ltd.
% Ivy Wang
Consultant
Shanghai SUNGO Management Consulting Co., Ltd.
Room 1401, Dongfang Building, 1500# Century Ave.
Shanghai, SH 200122
China

Re: K251347
Trade/Device Name: Sterilization Pouch/Roll
Regulation Number: 21 CFR 880.6850, 21 CFR 880.2800
Regulation Name: Sterilization Wrap, Sterilization process indicator
Regulatory Class: Class II
Product Code: FRG, JOJ
Dated: December 29, 2025
Received: December 29, 2025

Dear Ivy Wang:

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 (the 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 available 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.

U.S. Food & Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
www.fda.gov

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K251347 - Ivy Wang
Page 2

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reporting-combination-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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/unique-device-identification-system-udi-system.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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-devices/medical-device-safety/medical-device-reporting-mdr-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/medical-devices/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-devices/device-advice-comprehensive-regulatory-

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K251347 - Ivy Wang
Page 3

assistance/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,

STEPHEN A. ANISKO -S
Digitally signed by
STEPHEN A. ANISKO -S
Date: 2026.01.28
17:54:00 -05'00'

Stephen Anisko
Acting Assistant Director
DHT4C: Division of Infection Control 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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FORM FDA 3881 (8/23)
Page 1 of 4
PBC Publishing Services [phone]
EF

| DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Indications for Use | Form Approved: OMB No. 0910-0120 Expiration Date: 07/31/2026 See PRA Statement below. |
| --- | --- |
| 510(k) Number (if known) K251347 | |
| Device Name Sterilization Pouch/Roll | |
| Indications for Use (Describe) The Sterilization Pouch/Roll is 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: • Steam Sterilization at 132°C (270°F) for 4 minutes; Drying time of 20 minutes. • Ethylene Oxide (EO) with a concentration of 695 mg/L at 50°C (122°F) and 30% to 90% relative humidity for 4 hour. Aeration time of 7 days at room temperature. The Sterilization Pouch/Roll is made with medical grade paper and medical compound film. The Sterilization Pouch/Roll 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. Sterilization indicator will change color according to the sterilization method (ethylene oxide, steam). Ethylene oxide sterilization indicator color change from Pink before sterilization to Yellow after sterilization. The steam sterilization indicator color change from Blue before sterilization to Black after sterilization. The specification and recommended sterilization load of the device is following: see attached page | |
| 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) | |
| CONTINUE ON A SEPARATE PAGE IF NEEDED. | |
| This section applies only to requirements of the Paperwork Reduction Act of 1995. *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* | |
| The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff [e-mail] | |
| "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." | |

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The specification and recommended sterilization load of the device is following:

| Type | Product code | Specification (W*L) | | Content/Max Load (Ibs) | | |
| --- | --- | --- | --- | --- | --- | --- |
| | | Inch | mm*mm | Metal | Plastic | Gauze/linens |
| Sterilization Pouch | SVSP-050090 | 1.96"×2.36" | 50×90 | 0.015 | 0.015 | 0.002 |
| | SVSP-050225 | 1.96"×7.68" | 50×225 | 0.03 | 0.02 | 0.002 |
| | SVSP-050250 | 1.96"×8.67" | 50×250 | 0.03 | 0.02 | 0.004 |
| | SVSP-050260 | 1.96"×9.05" | 50×260 | 0.04 | 0.02 | 0.004 |
| | SVSP-057090 | 2.24"×2.36" | 57×90 | 0.02 | 0.015 | 0.005 |
| | SVSP-057100 | 2.24"×2.76" | 57×100 | 0.02 | 0.015 | 0.005 |
| | SVSP-057130 | 2.24"×3.94" | 57×130 | 0.04 | 0.02 | 0.006 |
| | SVSP-060100 | 2.36"×2.76" | 60×100 | 0.07 | 0.03 | 0.006 |
| | SVSP-060110 | 2.36"×3.15" | 60×110 | 0.07 | 0.03 | 0.006 |
| | SVSP-060135 | 2.36"×4.13" | 60×135 | 0.10 | 0.07 | 0.006 |
| | SVSP-060200 | 2.36"×6.7" | 60×200 | 0.27 | 0.13 | 0.006 |
| | SVSP-070255 | 2.76"×8.86" | 70×255 | 0.39 | 0.15 | 0.007 |
| | SVSP-070260 | 2.76"×9.1" | 70×260 | 0.40 | 0.15 | 0.007 |
| | SVSP-075150 | 2.95"×4.7" | 75×150 | 0.54 | 0.20 | 0.007 |
| | SVSP-080160 | 3.15"×5.1" | 80×160 | 0.66 | 0.30 | 0.007 |
| | SVSP-090100 | 3.54"×2.76" | 90×100 | 0.69 | 0.30 | 0.007 |
| | SVSP-090150 | 3.54"×4.7" | 90×150 | 0.72 | 0.40 | 0.008 |
| | SVSP-090165 | 3.54"×5.3" | 90×165 | 0.78 | 0.40 | 0.008 |
| | SVSP-090180 | 3.54"×5.9" | 90×180 | 0.81 | 0.48 | 0.008 |
| | SVSP-090210 | 3.54"×7.1" | 90×210 | 1.12 | 0.50 | 0.008 |
| | SVSP-090230 | 3.54"×7.87" | 90×230 | 1.14 | 0.50 | 0.008 |
| | SVSP-090260 | 3.54"×9.1" | 90×260 | 1.22 | 0.55 | 0.008 |
| | SVSP-100200 | 4"×6.69" | 100×200 | 1.43 | 0.68 | 0.009 |
| | SVSP-100230 | 4"×7.87" | 100×230 | 1.45 | 0.72 | 0.01 |
| | SVSP-100300 | 4"×10.6" | 100×300 | 1.53 | 0.86 | 0.01 |
| | SVSP-110305 | 4.3"×6.9" | 110×305 | 1.55 | 0.92 | 0.02 |
| | SVSP-115165 | 4.5"×5.3" | 115×165 | 1.48 | 1.04 | 0.03 |
| | SVSP-115230 | 4.5"×7.87" | 115×230 | 1.62 | 1.32 | 0.04 |
| | SVSP-115305 | 4.5"×10.8" | 115×305 | 1.65 | 1.50 | 0.04 |
| | SVSP-135260 | 5.3"×9.1" | 135×260 | 1.73 | 1.71 | 0.05 |
| SVSP-135280 | 5.3"×9.8" | 135×280 | 1.75 | 1.73 | 0.05 | |
| SVSP-135300 | 5.3"×10.6" | 135×300 | 1.80 | 1.78 | 0.05 | |
| SVSP-135360 | 5.3"×13" | 135×360 | 1.83 | 1.81 | 0.06 | |
| SVSP-140250 | 5.5"×8.7" | 140×250 | 1.83 | 1.82 | 0.07 | |

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| | SVSP-140305 | 5.5"×10.8" | 140×305 | 1.94 | 1.89 | 0.07 |
| --- | --- | --- | --- | --- | --- | --- |
| SVSP-150380 | 5.9"×13.8" | 150×380 | 2.05 | 1.96 | 0.09 |
| SVSP-160200 | 6.3"×6.7" | 160×200 | 2.08 | 2.02 | 0.05 |
| SVSP-160340 | 6.3"×12.2" | 160×340 | 2.13 | 2.11 | 0.09 |
| SVSP-165255 | 6.5"×8.86" | 165×255 | 2.24 | 2.21 | 0.09 |
| SVSP-190305 | 7.5"×10.8" | 190×305 | 2.43 | 2.41 | 0.09 |
| SVSP-190330 | 7.5"×11.8" | 190×330 | 2.44 | 2.44 | 0.10 |
| SVSP-190360 | 7.5"×13" | 190×360 | 2.51 | 2.48 | 0.10 |
| SVSP-190380 | 7.5"×13.8" | 190×380 | 2.53 | 2.51 | 0.10 |
| SVSP-200320 | 7.87"×11.4" | 200×320 | 2.53 | 2.52 | 0.10 |
| SVSP-200360 | 7.87"×13" | 200×360 | 2.53 | 2.54 | 0.11 |
| SVSP-200400 | 7.87"×14.6" | 200×400 | 2.62 | 2.65 | 0.11 |
| SVSP-205400 | 8.07"×14.6" | 205×400 | 2.62 | 2.65 | 0.11 |
| SVSP-220360 | 8.7"×13" | 220×360 | 2.74 | 2.72 | 0.20 |
| SVSP-230395 | 9.1"×14.4" | 230×395 | 2.95 | 2.92 | 0.28 |
| SVSP-230430 | 9.1"×15.7" | 230×430 | 3.03 | 3.02 | 0.32 |
| SVSP-250375 | 9.8"×13.6" | 250×375 | 3.32 | 3.31 | 0.32 |
| SVSP-250400 | 9.8"×14.6" | 250×400 | 3.51 | 3.48 | 0.38 |
| SVSP-260410 | 10.2"×15" | 260×410 | 3.72 | 3.68 | 0.38 |
| SVSP-300380 | 11.8"×13.8" | 300×380 | 4.06 | 4.02 | 0.46 |
| SVSP-300385 | 11.8"×14" | 300×385 | 4.10 | 4.06 | 0.46 |
| SVSP-300430 | 11.8"×15.7" | 300×430 | 4.10 | 4.08 | 0.52 |
| SVSP-300450 | 11.8"×16.5" | 300×450 | 4.52 | 4.50 | 0.58 |
| SVSP-305430 | 12"×15.7" | 305×430 | 4.53 | 4.51 | 0.58 |
| SVSP-360360 | 14.2"×13" | 360×360 | 4.84 | 4.82 | 0.58 |
| Sterilizati on Roll | SVFR-050100 | 1.96"×3937" | 50mm×100m | 0.015 | 0.015 | 0.003 |
| SVFR-050200 | 1.96"×7874" | 50mm×200m | 0.015 | 0.015 | 0.003 |
| SVFR-055100 | 2.16"×3937" | 55mm×100m | 0.02 | 0.02 | 0.006 |
| SVFR-055200 | 2.16"×7874" | 55mm×200m | 0.02 | 0.02 | 0.006 |
| SVFR-075100 | 2.95"×3937" | 75mm×100m | 0.40 | 0.40 | 0.01 |
| SVFR-075200 | 2.95"×7874" | 75mm×200m | 0.40 | 0.02 | 0.01 |
| SVFR-100100 | 4"×3937" | 100mm×100m | 1.25 | 1.18 | 0.02 |
| SVFR-100200 | 4"×7874" | 100mm×200m | 1.25 | 1.18 | 0.02 |

Page 3 of 4

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| | SVFR-120100 | 4.7"×3937" | 120mm×100m | 1.44 | 1.42 | 0.04 |
| --- | --- | --- | --- | --- | --- | --- |
| | SVFR-120200 | 4.7"×7874" | 120mm×200m | 1.44 | 1.42 | 0.04 |
| | SVFR-125100 | 4.9"×3937" | 125mm×100m | 1.52 | 1.51 | 0.06 |
| | SVFR-125200 | 4.9"×7874" | 125mm×200m | 1.52 | 1.51 | 0.06 |
| | SVFR-150100 | 5.9"×3937" | 150mm×100m | 1.98 | 1.92 | 0.08 |
| | SVFR-150200 | 5.9"×7874" | 150mm×200m | 1.98 | 1.92 | 0.08 |
| | SVFR-200100 | 7.87"×3937" | 200mm×100m | 2.56 | 2.52 | 0.10 |
| | SVFR-200200 | 7.87"×7874" | 200mm×200m | 2.56 | 2.52 | 0.10 |
| | SVFR-250100 | 9.8"×3937" | 250mm×100m | 3.08 | 3.01 | 0.08 |
| | SVFR-250200 | 9.8"×7874" | 250mm×200m | 3.08 | 3.01 | 0.08 |
| | SVFR-300100 | 11.8"×3937" | 300mm×100m | 3.24 | 3.05 | 0.10 |
| | SVFR-300200 | 11.8"×7874" | 300mm×200m | 3.24 | 3.05 | 0.10 |
| | SVFR-350100 | 13.78"×3937" | 350mm×100m | 3.36 | 3.31 | 0.10 |
| | SVFR-350200 | 13.78"×7874" | 350mm×200m | 3.36 | 3.31 | 0.10 |
| | SVFR-400100 | 15.75"×3937" | 400mm×100m | 3.52 | 3.49 | 0.25 |
| | SVFR-400200 | 15.75"×7874" | 400mm×200m | 3.52 | 3.49 | 0.25 |
| | SVFR-450100 | 17.7"×3937" | 450mm×100m | 4.12 | 4.08 | 0.30 |
| | SVFR-450200 | 17.7"×7874" | 450mm×200m | 4.12 | 4.08 | 0.30 |
| | SVFR-500100 | 19.69"×3937" | 500mm×100m | 4.56 | 4.56 | 0.40 |
| | SVFR-500200 | 19.69"×7874" | 500mm×200m | 4.56 | 4.56 | 0.40 |
| | SVFR-600100 | 23.62"×3937" | 600mm×100m | 5.20 | 5.03 | 0.40 |
| | SVFR-600200 | 23.62"×7874" | 600mm×200m | 5.20 | 5.03 | 0.40 |
| | SVFR-700100 | 27.56"×3937" | 700mm×100m | 5.20 | 5.07 | 0.50 |
| | SVFR-700200 | 27.56"×7874" | 700mm×200m | 5.20 | 5.07 | 0.50 |
| | SVFR-800100 | 31.5"×3937" | 800m×100m | 5.40 | 5.40 | 0.60 |
| | SVFR-800200 | 31.5"×7874" | 800mm×200m | 5.40 | 5.40 | 0.60 |

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STERIVIC

510(K) Summary
(K251347)

Prepared date: 2026-01-22

1. Applicant Information:
STERIVIC Medical Co., Ltd.
Address: DaDuKou Economic Development Zone, ChiZhou, Anhui, 247210 China
Contact: Jiang Wanggen
Tel: [phone]
Email: [e-mail]

Submission Correspondent:
Primary contact: Ms. Ivy Wang
Shanghai SUNGO Management Consulting Co., Ltd.
Room 1401, Dongfang Building, 1500# Century Ave., Shanghai 200122, China
Tel: [phone]
Email: [e-mail]
Secondary contact: Mr. Raymond Luo
Room 1401, Dongfang Building, 1500# Century Ave., Shanghai 200122, China
Tel: [phone]
Email: [e-mail]

2. Device Information
Trade Name: Sterilization Pouch/Roll
Model: Sterilization pouch, Sterilization roll
Common Name: Sterilization pouch/ roll

Regulatory Information
Classification Name: 1) Sterilization wrap; 2) Sterilization Process Indicator
Regulation Number: 1) 21 CFR 880.6850; 2) 21 CFR 880.2800
Product Code: FRG; JOJ
Device Class: 2
Review Panel: General Hospital

3. Predicate device
Manufacturer: Qianjiang Kingphar Medical Packaging & Printing Co., Ltd.
Trade Name: Sterilization pouch and roll
510(k) Number: K221875

Reference device:
Manufacturer: Sigma Medical Supplies Corp.
Trade Name: SIGMA Sterilization Pouch and Roll
510(k) Number: K180661

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K251347

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STERIVIC

# 4. Device Description

The Sterilization Pouch/Roll is composed of medical grade paper(60g/m2) and medical compound film(50μm), it is intended to be used to contain medical devices to be terminally sterilized by the EtO or Steam sterilization process.

The recommended sterilization cycle parameter is:

Steam: 4 minutes at 132°C(270°F); 20 minutes dry time.

Ethylene oxide: 4 hours at 50 °C(122°F); relative humidity between 30%- 90%; ethylene oxide concentration is 695 mg/L, 7 days aeration time at room temperature.

The medical devices are inserted into the Pouch/ Roll, sealed, and then sterilized for the EtO or Steam Sterilization Process. The pouch is self-sealed prior to sterilization processing. The roll is heat-sealed by a plastic sealing machine. 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 6 months post sterilization.

The Pouch/Roll is printed with a chemical indicator bar that changes from Pink to yellow (EtO) or Blue to Black (Steam) when exposed to EtO gas or Steam vapor during process. The EtO and Steam Chemical Indicator offers an addition 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 EtO and Steam Chemical Indicators do not signify sterilization; they only indicate that the indicator has been exposed to the EtO or Steam.

# 5. Indications for use

The Sterilization Pouch/Roll is 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:

- Steam Sterilization at 132°C (270°F) for 4 minutes; Drying time of 20 minutes.
- Ethylene Oxide (EO) with a concentration of 695 mg/L at 50°C (122°F) and 30% to 90% relative humidity for 4 hour. Aeration time of 7 days at room temperature.

The Sterilization Pouch/Roll is made with medical grade paper and medical compound film. The Sterilization Pouch/Roll 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. Sterilization indicator will change color according to the sterilization method (ethylene oxide, steam). Ethylene oxide sterilization indicator color change from Pink before sterilization to Yellow after sterilization. The steam sterilization indicator color change from Blue before sterilization to Black after sterilization.

The specification and recommended sterilization load of the device is following:

| Type | Product code | Specification (W*L) | | Content/Max Load (Ibs) | | |
| --- | --- | --- | --- | --- | --- | --- |
| | | Inch | mm*mm | Metal | Plastic | Gauze/ |

K251347

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STERIVIC

| | | | | | | linens |
| --- | --- | --- | --- | --- | --- | --- |
| Sterilizati on Pouch | SVSP-050090 | 1.96"×2.36" | 50×90 | 0.015 | 0.015 | 0.002 |
| | SVSP-050225 | 1.96"×7.68" | 50×225 | 0.03 | 0.02 | 0.002 |
| | SVSP-050250 | 1.96"×8.67" | 50×250 | 0.03 | 0.02 | 0.004 |
| | SVSP-050260 | 1.96"×9.05" | 50×260 | 0.04 | 0.02 | 0.004 |
| | SVSP-057090 | 2.24"×2.36" | 57×90 | 0.02 | 0.015 | 0.005 |
| | SVSP-057100 | 2.24"×2.76" | 57×100 | 0.02 | 0.015 | 0.005 |
| | SVSP-057130 | 2.24"×3.94" | 57×130 | 0.04 | 0.02 | 0.006 |
| | SVSP-060100 | 2.36"×2.76" | 60×100 | 0.07 | 0.03 | 0.006 |
| | SVSP-060110 | 2.36"×3.15" | 60×110 | 0.07 | 0.03 | 0.006 |
| | SVSP-060135 | 2.36"×4.13" | 60×135 | 0.10 | 0.07 | 0.006 |
| | SVSP-060200 | 2.36"×6.7" | 60×200 | 0.27 | 0.13 | 0.006 |
| | SVSP-070255 | 2.76"×8.86" | 70×255 | 0.39 | 0.15 | 0.007 |
| | SVSP-070260 | 2.76"×9.1" | 70×260 | 0.40 | 0.15 | 0.007 |
| | SVSP-075150 | 2.95"×4.7" | 75×150 | 0.54 | 0.20 | 0.007 |
| | SVSP-080160 | 3.15"×5.1" | 80×160 | 0.66 | 0.30 | 0.007 |
| | SVSP-090100 | 3.54"×2.76" | 90×100 | 0.69 | 0.30 | 0.007 |
| | SVSP-090150 | 3.54"×4.7" | 90×150 | 0.72 | 0.40 | 0.008 |
| | SVSP-090165 | 3.54"×5.3" | 90×165 | 0.78 | 0.40 | 0.008 |
| | SVSP-090180 | 3.54"×5.9" | 90×180 | 0.81 | 0.48 | 0.008 |
| | SVSP-090210 | 3.54"×7.1" | 90×210 | 1.12 | 0.50 | 0.008 |
| | SVSP-090230 | 3.54"×7.87" | 90×230 | 1.14 | 0.50 | 0.008 |
| | SVSP-090260 | 3.54"×9.1" | 90×260 | 1.22 | 0.55 | 0.008 |
| | SVSP-100200 | 4"×6.69" | 100×200 | 1.43 | 0.68 | 0.009 |
| | SVSP-100230 | 4"×7.87" | 100×230 | 1.45 | 0.72 | 0.01 |
| | SVSP-100300 | 4"×10.6" | 100×300 | 1.53 | 0.86 | 0.01 |
| | SVSP-110305 | 4.3"×6.9" | 110×305 | 1.55 | 0.92 | 0.02 |
| | SVSP-115165 | 4.5"×5.3" | 115×165 | 1.48 | 1.04 | 0.03 |
| | SVSP-115230 | 4.5"×7.87" | 115×230 | 1.62 | 1.32 | 0.04 |
| | SVSP-115305 | 4.5"×10.8" | 115×305 | 1.65 | 1.50 | 0.04 |
| | SVSP-135260 | 5.3"×9.1" | 135×260 | 1.73 | 1.71 | 0.05 |
| | SVSP-135280 | 5.3"×9.8" | 135×280 | 1.75 | 1.73 | 0.05 |
| | SVSP-135300 | 5.3"×10.6" | 135×300 | 1.80 | 1.78 | 0.05 |
| | SVSP-135360 | 5.3"×13" | 135×360 | 1.83 | 1.81 | 0.06 |
| | SVSP-140250 | 5.5"×8.7" | 140×250 | 1.83 | 1.82 | 0.07 |
| | SVSP-140305 | 5.5"×10.8" | 140×305 | 1.94 | 1.89 | 0.07 |
| | SVSP-150380 | 5.9"×13.8" | 150×380 | 2.05 | 1.96 | 0.09 |

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| Sterilizati on Roll | SVSP-160200 | 6.3"×6.7" | 160×200 | 2.08 | 2.02 | 0.05 |
| --- | --- | --- | --- | --- | --- | --- |
| | SVSP-160340 | 6.3"×12.2" | 160×340 | 2.13 | 2.11 | 0.09 |
| | SVSP-165255 | 6.5"×8.86" | 165×255 | 2.24 | 2.21 | 0.09 |
| | SVSP-190305 | 7.5"×10.8" | 190×305 | 2.43 | 2.41 | 0.09 |
| | SVSP-190330 | 7.5"×11.8" | 190×330 | 2.44 | 2.44 | 0.10 |
| | SVSP-190360 | 7.5"×13" | 190×360 | 2.51 | 2.48 | 0.10 |
| | SVSP-190380 | 7.5"×13.8" | 190×380 | 2.53 | 2.51 | 0.10 |
| | SVSP-200320 | 7.87"×11.4" | 200×320 | 2.53 | 2.52 | 0.10 |
| | SVSP-200360 | 7.87"×13" | 200×360 | 2.53 | 2.54 | 0.11 |
| | SVSP-200400 | 7.87"×14.6" | 200×400 | 2.62 | 2.65 | 0.11 |
| | SVSP-205400 | 8.07"×14.6" | 205×400 | 2.62 | 2.65 | 0.11 |
| | SVSP-220360 | 8.7"×13" | 220×360 | 2.74 | 2.72 | 0.20 |
| | SVSP-230395 | 9.1"×14.4" | 230×395 | 2.95 | 2.92 | 0.28 |
| | SVSP-230430 | 9.1"×15.7" | 230×430 | 3.03 | 3.02 | 0.32 |
| | SVSP-250375 | 9.8"×13.6" | 250×375 | 3.32 | 3.31 | 0.32 |
| | SVSP-250400 | 9.8"×14.6" | 250×400 | 3.51 | 3.48 | 0.38 |
| | SVSP-260410 | 10.2"×15" | 260×410 | 3.72 | 3.68 | 0.38 |
| | SVSP-300380 | 11.8"×13.8" | 300×380 | 4.06 | 4.02 | 0.46 |
| | SVSP-300385 | 11.8"×14" | 300×385 | 4.10 | 4.06 | 0.46 |
| | SVSP-300430 | 11.8"×15.7" | 300×430 | 4.10 | 4.08 | 0.52 |
| | SVSP-300450 | 11.8"×16.5" | 300×450 | 4.52 | 4.50 | 0.58 |
| | SVSP-305430 | 12"×15.7" | 305×430 | 4.53 | 4.51 | 0.58 |
| | SVSP-360360 | 14.2"×13" | 360×360 | 4.84 | 4.82 | 0.58 |
| | SVSP-400400 | 15.7"×14.6" | 400×400 | 5.01 | 5.02 | 0.64 |
| | SVSP-400535 | 15.7"×20" | 400×535 | 5.25 | 5.22 | 0.64 |
| | SVSP-400580 | 15.7"×21.7" | 400×580 | 5.38 | 5.38 | 0.64 |
| | SVSP-400600 | 15.7"×22.4" | 400×600 | 5.42 | 5.40 | 0.64 |
| Sterilizati on Roll | SVFR-050100 | 1.96"×3937" | 50mm×100m | 0.015 | 0.015 | 0.003 |
| | SVFR-050200 | 1.96"×7874" | 50mm×200m | 0.015 | 0.015 | 0.003 |
| | SVFR-055100 | 2.16"×3937" | 55mm×100m | 0.02 | 0.02 | 0.006 |
| | SVFR-055200 | 2.16"×7874" | 55mm×200m | 0.02 | 0.02 | 0.006 |
| | SVFR-075100 | 2.95"×3937" | 75mm×100m | 0.40 | 0.40 | 0.01 |
| | SVFR-075200 | 2.95"×7874" | 75mm×200m | 0.40 | 0.02 | 0.01 |
| | SVFR-100100 | 4"×3937" | 100mm×100m | 1.25 | 1.18 | 0.02 |
| | SVFR-100200 | 4"×7874" | 100mm×200m | 1.25 | 1.18 | 0.02 |
| | SVFR-120100 | 4.7"×3937" | 120mm×100m | 1.44 | 1.42 | 0.04 |
| | SVFR-120200 | 4.7"×7874" | 120mm×200m | 1.44 | 1.42 | 0.04 |

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| | SVFR-125100 | 4.9"×3937" | 125mm×100m | 1.52 | 1.51 | 0.06 |
| --- | --- | --- | --- | --- | --- | --- |
| | SVFR-125200 | 4.9"×7874" | 125mm×200m | 1.52 | 1.51 | 0.06 |
| | SVFR-150100 | 5.9"×3937" | 150mm×100m | 1.98 | 1.92 | 0.08 |
| | SVFR-150200 | 5.9"×7874" | 150mm×200m | 1.98 | 1.92 | 0.08 |
| | SVFR-200100 | 7.87"×3937" | 200mm×100m | 2.56 | 2.52 | 0.10 |
| | SVFR-200200 | 7.87"×7874" | 200mm×200m | 2.56 | 2.52 | 0.10 |
| | SVFR-250100 | 9.8"×3937" | 250mm×100m | 3.08 | 3.01 | 0.08 |
| | SVFR-250200 | 9.8"×7874" | 250mm×200m | 3.08 | 3.01 | 0.08 |
| | SVFR-300100 | 11.8"×3937" | 300mm×100m | 3.24 | 3.05 | 0.10 |
| | SVFR-300200 | 11.8"×7874" | 300mm×200m | 3.24 | 3.05 | 0.10 |
| | SVFR-350100 | 13.78"×3937" | 350mm×100m | 3.36 | 3.31 | 0.10 |
| | SVFR-350200 | 13.78"×7874" | 350mm×200m | 3.36 | 3.31 | 0.10 |
| | SVFR-400100 | 15.75"×3937" | 400mm×100m | 3.52 | 3.49 | 0.25 |
| | SVFR-400200 | 15.75"×7874" | 400mm×200m | 3.52 | 3.49 | 0.25 |
| | SVFR-450100 | 17.7"×3937" | 450mm×100m | 4.12 | 4.08 | 0.30 |
| | SVFR-450200 | 17.7"×7874" | 450mm×200m | 4.12 | 4.08 | 0.30 |
| | SVFR-500100 | 19.69"×3937" | 500mm×100m | 4.56 | 4.56 | 0.40 |
| | SVFR-500200 | 19.69"×7874" | 500mm×200m | 4.56 | 4.56 | 0.40 |
| | SVFR-600100 | 23.62"×3937" | 600mm×100m | 5.20 | 5.03 | 0.40 |
| | SVFR-600200 | 23.62"×7874" | 600mm×200m | 5.20 | 5.03 | 0.40 |
| | SVFR-700100 | 27.56"×3937" | 700mm×100m | 5.20 | 5.07 | 0.50 |
| | SVFR-700200 | 27.56"×7874" | 700mm×200m | 5.20 | 5.07 | 0.50 |
| | SVFR-800100 | 31.5"×3937" | 800m×100m | 5.40 | 5.40 | 0.60 |
| | SVFR-800200 | 31.5"×7874" | 800mm×200m | 5.40 | 5.40 | 0.60 |

6. Technological Characteristics Comparison Table

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| Device | Subject Device | Predicate Device | Reference Device | Result |
| --- | --- | --- | --- | --- |
| 510K number | K251347 | K221875 | K180661 | - |
| Product name | Sterilization Pouch/ Roll | Sterilization Pouch and Roll | SIGMA Sterilization Pouch and Roll | - |
| Classification | Class II | Class II | Class II | Same |
| Regulation | 21 CFR 880.6850
21 CFR 880.2800 | 21 CFR 880.6850
21 CFR 880.2800 | 21 CFR 880.6850 | Same |
| Product code | FRG; JOJ | FRG; JOJ | FRG | Same |
| Intended use/
Indications for use | The Sterilization Pouch/Roll is 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:
• Steam Sterilization at 132°C (270°F) for 4 minutes; Drying time of 20 minutes.
• Ethylene Oxide (EO) with a concentration of 695 mg/L at 50°C (122°F) and 30% to 90% relative humidity for 4 hour. Aeration time of 7 days at room temperature.

The Sterilization Pouch/Roll is made with medical grade paper and medical compound film. The Sterilization Pouch/Roll 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 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:
• Steam Sterilization at 132°C (270°F) for 4 minutes; Drying time of 20 minutes.
• Ethylene Oxide (EO) with a concentration of 800 mg/L at 55°C (131°F) and 40% to 90% relative humidity for 6 hour. Aeration time of 7 days at 20°C).

The sterilization pouch and roll are made with medical grade paper and medical compound film. The sterilization pouch and roll maintains the sterility of the enclosed devices for up to 24 months post Steam or EO gas sterilization, and before sterilization has a maximum shelf | The SIGMA sterilization pouch and roll are intended to provide health care workers with an effective method to enclose devices intended for sterilization in steam auto claves and via Ethylene Oxide (EO). The recommended steam sterilization cycle parameters are 30 minutes at 121 °C . The recommended EO sterilization cycle is 4 hours at 55°C with a relative humidity between 50%-85% and a sterilant concentration of 600 mg/L. Furthermore, the sterilization pouch and roll maintains the enclosed devices up until 3 years post EO gas sterilization and maintains | Similar |

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| | 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. Sterilization indicator will change color according to the sterilization method (ethylene oxide, steam). Ethylene oxide sterilization indicator color change from Pink before sterilization to Yellow after sterilization. The steam sterilization indicator color change from Blue before sterilization to Black after sterilization. | life of 5 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. Sterilization indicator will change color according to the sterilization method (ethylene oxide, steam). Ethylene oxide sterilization indicator color change from pink before sterilization to yellow after sterilization. The steam sterilization indicator color change from blue before sterilization to dark grey after sterilization. | the enclosed devices up until 6 months post Steam sterilization. Lastly, 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 SIGMA sterilization pouch and roll is offered in the following 5 types: - Self-sealing sterilization pouches - Sterilization pouches, Flat - Sterilization pouches, Gusseted - Sterilization rolls, Flat - Sterilization rolls, Gusseted | |
| --- | --- | --- | --- | --- |
| Material Composition | Medical Grade Paper, CPP, PET, PU adhesive, EO and Steam Process Indicator Print Ink | Composed of medical grade paper and medical compound film, EO and Steam Process Indicator | Medical Grade Paper, CPP, PET, PU adhesive, EO and Steam Process Indicator Print Ink | Same with reference device |
| Sterilization cycles | • Steam Sterilization at 132°C (270°F) for 4 minutes; Drying time of 20 minutes. • Ethylene Oxide (EO) with a concentration of 695 mg/L at 50°C (122°F) and 30% to 90% relative humidity for 4 hour. Aeration time of 7 days at room temperature. | • Steam Sterilization at 132°C (270°F) for 4 minutes; Drying time of 20 minutes. • Ethylene Oxide (EO) with a concentration of 800 mg/L at 55°C (131°F) and 40% to 90% relative humidity for 6 hour. Aeration time of 7 days at 20°C). | • Steam sterilization cycle parameters are 30 minutes at 121°C. • EO sterilization cycle is 4 hours at 55°C with a relative humidity between 50%-85% and a sterilant concentration of 600 mg/L | Different |

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| Configuration/ dimension | Various size, heat sealing and self sealing | Various size, heat sealing | Various size, heat sealing and self sealing | Same with reference device |
| --- | --- | --- | --- | --- |
| Performance testing | | | | |
| Sterilant Penetration Efficacy | The test meet the requirement of SAL 10^{-6} | The test meet the requirement of SAL 10^{-6} | The test meet the requirement of SAL 10^{-6} | Same |
| Chemical Indicator (CI) Functionality and Endpoint | The sterilant penetrated through the pouch configuration and affected the CI color change to the endpoint color | The sterilant penetrated through the pouch configuration and affected the CI color change to the endpoint color | The sterilant penetrated through the pouch configuration and affected the CI color change to the endpoint color | Same |
| Device Design of Steam CI | The color of Chemical Indicator changes from blue to black, when exposed to Steam | The color of Chemical Indicator changes from Blue to dark grey, when exposed to Steam | The color of Chemical Indicator changes from Blue to Greenish Black, when exposed to Steam | Similar |
| Device Design of EO gas CI | The color of Chemical Indicator changes from Pink to Yellow, when exposed to EO gas | The color of Chemical Indicator changes from Pink to Yellow, when exposed to EO gas | The color changes from - Red to Yellow, when exposed to EO gas | Similar |
| Thickness Variations (mm) ASTM F 2251 | Passed | Passed | Passed | Same |
| Tensile strength ISO 1924-2 | Passed | Passed | Passed | Same |
| Burst Strength (kPa) ASTM F1140; ISO 11607-1 | > 3.0 Kpa
Passed | Passed | Passed | Same |

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| Leak test
ASTM-F 2096 | No leakage
Passed | Passed | Passed | Same |
| --- | --- | --- | --- | --- |
| Seal strength
(N/15mm)
ASTM F88/F88M | Min value= 2.53
Passed | Passed | Passed | Same |
| Dye penetration Test
ASTM F1929 ;
ISO 11607-1 | No Infiltration
Passed | Passed | Passed | Same |
| Microbial Barrier Test | LRV ≥ 1.0 (ASTM F1608)
Passed | CFU = 0 (DIN 58953-6)
Passed | Passed (DIN 58953-6) | Same |
| End point stability
testing results | The color of chemical indicator for EO sterilization indicator ink is Pink, and the color of chemical indicator for steam sterilization indicator ink is Blue after 3 years shelf life before sterilization. | The color of chemical indicator for EO sterilization indicator ink is Pink, and the color of chemical indicator for steam sterilization indicator ink is Blue after 5 year shelf life before sterilization. | The color of chemical indicator for EO sterilization indicator ink is Red, and the color of chemical indicator for steam sterilization indicator ink is Blue after 3 year shelf life before sterilization. | Similar |
| | The color of chemical indicator for EO sterilization indicator ink is Yellow, and the color of chemical indicator for steam sterilization indicator ink is Blue after EO sterilized and 6 months shelf life. | The color of chemical indicator for EO sterilization indicator ink is Yellow, and the color of chemical indicator for steam sterilization indicator ink is Blue after EO sterilized and 24 months shelf life. | The color of chemical indicator for EO sterilization indicator ink is yellow, and the color of chemical indicator for steam sterilization indicator ink is Blue after EO sterilized and 3 years shelf life. | |
| | The color of chemical indicator for EO sterilization indicator ink is Pink, the color of chemical indicator for steam sterilization indicator ink is Black after steam sterilized and 6 months shelf life. | The color of chemical indicator for EO sterilization indicator ink is Pink, and the color of chemical indicator for steam sterilization indicator ink is Dark Grey after steam sterilized and 24 months | The color of chemical indicator for EO sterilization indicator ink is Red, and the color of chemical indicator for steam sterilization indicator ink is Greenish Black | |

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| | | shelf life. | after steam sterilized and 6 months shelf life. | |
| --- | --- | --- | --- | --- |
| Maintenance of Sterility | 6 months | 24 months | 3 years post EO gas sterilization
6 months post Steam sterilization | Similar |
| Shelf life | 3 years from date of manufacture for EO and Steam Indicators | 5 years from date of manufacture for EO and Steam Indicators | 3 years from date of manufacture for EO and Steam Indicators | Same with reference device |
| Biocompatibility | Conform with ISO 10993 standards | Conform with ISO10993 standards | Conform with ISO10993 standards | Same |

The technological characteristics of the subject device are similar to those of predicate device. The subject device has the same basic design as the predicate device.

The comparison between the subject and predicate devices is based on the following:

- Same intended use
- Same indications for use
- Similar material types that meet ISO 10993 biocompatibility requirements
- Same sterilization methods (EO and Steam sterilization process)
- Same fundamental technology/principal of operation/user interface

The subject device and the predicate device are identical in most key safety and effectiveness technical characteristics, such as basic design, sterilization method principles, physical properties (such as sealing strength, burst strength, microbial barrier) and biocompatibility. However, as shown in the comparison table, there are some differences, mainly concentrated in material composition, chemical indicator color, sterilization cycle parameters and shelf life. The following briefly discusses these differences:

- Material composition difference: Both subject device and predicate device consists of paper and compound film and chemical indicator, while the subject device has one more adhesive which is to seal the pouch. The biocompatibility tests were done to the subject device and its test results were positive.

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- Chemical indicator color difference: Chemical indicator is to indicate exposure to a specific sterilization process (EO or steam) through clear, distinct, and observable color change. Although the indicator color is different, both chemical indicators comply with the requirements of ISO 11140-1 and provide equivalent process monitoring capabilities.
- Difference in Sterilization cycle parameters: The subject device has undergone independent sterilization process validation in accordance with ISO 11135 (EO) and ISO 17665-1 (steam) standards. The results demonstrated that it can achieve a sterilization assurance level of SAL 10⁻⁶ under the specified parameters.
- Shelf-life difference: The declaration for the aseptic preservation period of the subject device is 6 months (compared to 24 months), and the shelf life (before sterilization) is 3 years (compared to 5 years). This statement is designed to meet market demands and actual usage patterns and is supported by sufficient test data.

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# 7. Summary of Non-Clinical Testing

Summary of non-clinical and performance testing bench testing was performed to evaluate the performance and functionality of the subject device against requirement specification. The conducted tests listed as below:

| Test Item | Test Method | Acceptance Criteria | Test Results |
| --- | --- | --- | --- |
| Sterilization process validation | ISO 11135:2014 | Ethylene Oxide (EO): 4 hours at 50°C (122°F) and 30% to 90% relative humidity with a concentration of 695 mg/L; 7 days aeration time at room temperature SAL=10-6 | Pass |
| | ISO 17665-1:2006 | Steam: 4 minutes at 132°C (270°F); 20 minutes drying time. SAL=10-6 | Pass |
| EO residuals | ISO 10993-7:2008 | EO ≤ 4 mg/device ECH ≤ 9 mg/device | Pass |
| Cytotoxicity | ISO 10993-5:2009 | Non-cytotoxic | Pass |
| Sensitization | ISO 10993-10:2021 | Non-sensitizing | Pass |
| Irritation | ISO 10993-23:2021 | Non-irritating | Pass |
| Physical Performance | | | |
| Thickness | ASTM F2251-2013 (2023) | Paper:90±5μm Plastic:50±5μm | Pass |
| Tensile Strength | ISO 19244-2: 2008 | MD: ≥4.4kN/m CD: ≥2.2kN/m | Pass. All samples met the requirements for Machine Direction and Cross Direction. |
| Seal Strength | ASTM F88/F88M-2023 | ≥2.5N/15mm | Pass. All tested samples demonstrated seal strength greater than 2.5N/15mm. |
| Burst Strength | ASTM F1140/F1140M-13 (R2020) | Burst value > 3 kPa | Pass. All samples withstood internal pressurization greater than 3 kPa. |
| Dy Penetration | ASTM F1929-2023 | No penetration | Pass. No dye penetration was |

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| | | | observed in the seal area. |
| --- | --- | --- | --- |
| Leak Test (Bubble) | ASTM F2096-11:2019 | No leakage | Pass. No leakage was found |
| Microbial Barrier | ASTM F1608-2021 | LRV≥1.0 | Pass. The Log Reduction Value (LRV) was greater than 1.0. |
| Chemical Indicator | ISO 11140-1:2014 Premarket Notification [510(k)] Submissions for Chemical Indicators - Guidance for Industry and FDA Staff | Color change to endpoint Steam sterile: The color of Chemical Indicator changes from Blue to Black, when exposed to Steam; EO sterile: The color of Chemical Indicator changes from Pink to Yellow, when exposed to EO gas. Remain stable before use based on its shelf life. Maintain the endpoint stability of the color change after being in the presence of the sterilant. Off-set (transference): Migration of the indicator agent through the substrate to the surface opposite the one to which the indicator agent was applied shall not occur before, during or after the sterilization process. In use, the indicator agent shall not offset or bleed, penetrate the substrate to which it is applied or materials in which it is in contact. | Pass |
| Shelf Life & Sterility Maintenance | | | |
| Shelf Life | ASTM F1980-21 | Maintain integrity after 3-year aging | Pass. Physical properties (Seal strength, Burst, Dye penetration) met acceptance criteria after |

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| | | | aging. |
| --- | --- | --- | --- |
| Sterility Maintenance | Real-time Aging | Sterile after 6 months post-sterilization storage | Pass.
Products remained sterile and package integrity was maintained after 6 months of storage following sterilization. |

## 8. Clinical Test Conclusion

No clinical study is included in this submission.

## 9. Conclusion

The conclusions drawn from the nonclinical tests demonstrate that the subject device is as safe, as effective, and performs as well as or better than the legally marketed predicate device K221875.

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