(240 days)
The Self-Seal 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 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 Self-Seal Sterilization Pouch and Roll are made with medical grade paper and medical compound film. The Self Sealing Sterilization Pouch and 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 changes from red before sterilization to brown after sterilization. The steam sterilization indicator color changes from blue before sterilization to greenish black after sterilization.
The Self-Seal Sterilization Pouch and Roll is composed of medical grade paper (60g/m²) and PET/CPP medical compound film (52 μm), 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 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 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 not self-sealed; use a plastic sealing machine to seal it, and the temperature of the plastic sealing machine needs to reach 205°C, 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 blue to greenish black (Steam) or red to brown (EtO) when exposed to EtO gas or Steam vapor during process. The EtO and Steam 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. The EtO and Steam Chemical Indicators do not signify sterilization; they only indicate that the indicator has been exposed to the EtO or Steam.
N/A
FDA 510(k) Clearance Letter - Self-Seal Sterilization Pouch and Roll
Page 1
U.S. Food & Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
www.fda.gov
Doc ID # 04017.08.02
December 12, 2025
Guangdong Maidi Medical Co., Ltd.
℅ Kiwi Xu
Official Correspondent
Shanghai SUNGO Management Consulting Co., Ltd.
14th Floor, Dongfang Building, 1500# Century Ave.
Shanghai,
China
Re: K251177
Trade/Device Name: Self-Seal Sterilization Pouch and Roll
Regulation Number: 21 CFR 880.6850
Regulation Name: Sterilization Wrap
Regulatory Class: Class II
Product Code: FRG, JOJ
Dated: November 13, 2025
Received: November 13, 2025
Dear Kiwi Xu:
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.
Page 2
K251177 - Kiwi Xu
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-
Page 3
K251177 - Kiwi Xu
Page 3
assistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
STEPHEN A. ANISKO -S
Digitally signed by STEPHEN A. ANISKO -S
Date: 2025.12.12 14:55:05 -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
Page 4
FORM FDA 3881
Page 1 of 2
PSC Publishing Services (301) 443-6740 EF (8/23)
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): K251177
Device Name: Self-Seal Sterilization Pouch and Roll
Indications for Use (Describe)
The Self-Seal 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 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 Self-Seal Sterilization Pouch and Roll are made with medical grade paper and medical compound film. The Self Sealing Sterilization Pouch and 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 changes from red before sterilization to brown after sterilization. The steam sterilization indicator color changes from blue before sterilization to greenish black after sterilization.
| Model | Product code | Specification (W*L) | Maximum load (lbs) | |||
|---|---|---|---|---|---|---|
| Inch | mm | Metal | Plastic | Gauze/Linens | ||
| Sterilization Pouch | ||||||
| WMDS.060-130 | 2 1/4" x 5" | 60mm × 130mm | 0.04 | 0.0057 | 0.005 | |
| WMDS.070-183 | 2 3/4" x 7 1/5" | 70mm × 183mm | 0.07 | 0.03 | 0.005 | |
| WMDS.070-260 | 2 3/4" x 10 1/4" | 70mm × 260mm | 0.09 | 0.08 | 0.07 | |
| WMDS.075-185 | 3" x 7 3/10" | 75mm × 185mm | 0.12 | 0.1 | 0.08 | |
| WMDS.090-170 | 3 1/2" x 6 3/4" | 90mm × 170mm | 0.12 | 0.11 | 0.09 | |
| WMDS.090-230 | 3 1/2" x 9" | 90mm × 230mm | 0.13 | 0.12 | 0.11 | |
| WMDS.090-260 | 3 1/2" x 10 1/4" | 90mm × 260mm | 0.14 | 0.13 | 0.11 | |
| WMDS.120-190 | 4 7/10" x 7 1/2" | 120mm×190mm | 0.21 | 0.2 | 0.12 | |
| WMDS.130-260 | 5 1/10" x 10 1/4" | 130mm×260mm | 0.48 | 0.39 | 0.19 | |
| WMDS.135-290 | 5 1/4" x 11 1/2" | 135m × 290mm | 0.5 | 0.4 | 0.21 | |
| WMDS.150-230 | 6" x 9" | 150mm×230mm | 0.56 | 0.4 | 0.21 | |
| WMDS.180-272 | 7" x 10 7/10" | 180mm×272mm | 0.58 | 0.42 | 0.22 | |
| WMDS.195-360 | 7 3/4" x 14 1/4" | 195mm×360mm | 0.6 | 0.43 | 0.23 | |
| WMDS.240-320 | 9 2/5" x 12 3/5" | 240mm×320mm | 1.94 | 0.46 | 0.24 | |
| WMDS.250-400 | 9 4/5" x 15 3/4" | 250mm×400mm | 3.34 | 0.48 | 0.26 | |
| WMDS.300-400 | 11 4/5" x 15 3/4" | 300mm×400mm | 3.34 | 0.69 | 0.3 | |
| WMDS.390-400 | 15 3/10" x 15 3/4" | 390mm×400mm | 3.34 | 0.8 | 0.32 | |
| WMDS.500-600 | 19 7/10" x 23 3/5" | 500mm×600mm | 3.34 | 1.03 | 0.48 |
Page 5
FORM FDA 3881 (8/23)
Page 2 of 2
| Model | Product code | Specification (W*L) | Maximum load (lbs) | |||
|---|---|---|---|---|---|---|
| Inch | mm | Metal | Plastic | Gauze/Linens | ||
| Sterilization Roll | ||||||
| WMDR.055-200 | 2 1/5" | 55mm×200m | 0.07 | 0.03 | 0.003 | |
| WMDR.075-200 | 3" | 75mm×200m | 0.09 | 0.05 | 0.004 | |
| WMDR.100-200 | 4" | 100mm×200m | 0.14 | 0.13 | 0.11 | |
| WMDR.150-200 | 6" | 150mm×200m | 0.55 | 0.53 | 0.5 | |
| WMDR.200-200 | 8" | 200mm×200m | 0.6 | 0.58 | 0.55 | |
| WMDR.250-200 | 10" | 250mm×200m | 1.06 | 1.05 | 0.62 | |
| WMDR.350-200 | 12" | 300mm×200m | 0.6 | 0.58 | 0.55 | |
| WMDR.300-200 | 14" | 350mm×200m | 1.06 | 1.05 | 0.62 | |
| WMDR.400-600 | 16" | 400mm×200m | 1.08 | 1.06 | 0.63 |
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
PRAStaff@fda.hhs.gov
"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."
Page 6
510(k) Summary (K251177)
Page 1 of 9
This summary of 510(k) safety and effectiveness information is being submitted in accordance with requirements of 21 CFR 807.92.
1.0 Submitter's Information
Name: Guangdong Maidi Medical Co., Ltd.
Address: No.3, Zhihui Rd, Guangzhou (Qingyuan) Industrial Transfer Industrial Park, Shijiao Town, Qingyuan, 511545, Guangdong, P.R. China
Tel: +86-20-82031350
Contact: Shi Xiong
Date Submitted: December 11, 2025.
Designated Submission Correspondent
Contact: Kiwi Xu
Name: Shanghai SUNGO Management Consulting Co., Ltd.
Address: 14th Floor, Dongfang Building, 1500# Century Ave., Pudong Area, Shanghai, 200120 China
Tel: +86-21-58817802
Email: weijia.xu@sungoglobal.com
2.0 Device Information
Trade/Device name: Self-Seal Sterilization Pouch and Roll
Common name: Sterilization Pouch and Roll
Regulation Name: 1) Sterilization Wrap; 2) Sterilization process indicator
Classification Product Code: 1) FRG; Subsequent Product Code: 2) JOJ
Regulation number: 1) 21 CFR880.6850 2) 21 CFR880.2800
Classification: Class II
Panel: General Hospital
Page 7
3.0 Predicate Device Information
Predicate Device:
Manufacturer: Qianjiang Kingphar Medical Packaging & Printing Co., Ltd.
Trade/Device Name: Sterilization Pouch and Roll
510(k) number: K221875
4.0 Device Description
The Self-Seal Sterilization Pouch and Roll is composed of medical grade paper (60g/m²) and PET/CPP medical compound film (52 μm), 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 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 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 not self-sealed; use a plastic sealing machine to seal it, and the temperature of the plastic sealing machine needs to reach 205°C, 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 blue to greenish black (Steam) or red to brown (EtO) when exposed to EtO gas or Steam vapor during process. The EtO and Steam 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. The EtO and Steam Chemical Indicators do not signify sterilization; they only indicate that the indicator has been exposed to the EtO or Steam.
5.0 Indication for Use Statement
The Self-Seal 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 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 Self-Seal Sterilization Pouch and Roll are made with medical grade paper and medical compound film. The Self Sealing Sterilization Pouch and Roll maintains the
Page 8
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 changes from red before sterilization to brown after sterilization. The steam sterilization indicator color changes from blue before sterilization to greenish black after sterilization.
Table 1 Model and Dimension
| Model | Product code | Specification (W*L) | Maximum load(lbs) | |||
|---|---|---|---|---|---|---|
| Inch | mm | Metal | Plastic | Gauze/Linens | ||
| Sterilization Pouch | ||||||
| WMDS.060-130 | 2¼"×5" | 60mm × 130mm | 0.04 | 0.0057 | 0.005 | |
| WMDS.070-183 | 2¾"×7⅕" | 70mm × 183mm | 0.07 | 0.03 | 0.005 | |
| WMDS.070-260 | 2¾"×10¼" | 70mm × 260mm | 0.09 | 0.08 | 0.07 | |
| WMDS.075-185 | 3"×7³⁄₁₀" | 75mm × 185mm | 0.12 | 0.10 | 0.08 | |
| WMDS.090-170 | 3½"×6¾" | 90mm × 170mm | 0.12 | 0.11 | 0.09 | |
| WMDS.090-230 | 3½"×9" | 90mm × 230mm | 0.13 | 0.12 | 0.11 | |
| WMDS.090-260 | 3½"×10¼" | 90mm × 260mm | 0.14 | 0.13 | 0.11 | |
| WMDS.120-190 | 4⁷⁄₁₀"×7½" | 120mm×190mm | 0.21 | 0.20 | 0.12 | |
| WMDS.130-260 | 5¹⁄₁₀"×10¼" | 130mm×260mm | 0.48 | 0.39 | 0.19 | |
| WMDS.135-290 | 5¼"×11½" | 135m × 290mm | 0.50 | 0.40 | 0.21 | |
| WMDS.150-230 | 6"×9" | 150mm×230mm | 0.56 | 0.40 | 0.21 | |
| WMDS.180-272 | 7"×10⁷⁄₁₀" | 180mm×272mm | 0.58 | 0.42 | 0.22 | |
| WMDS.195-360 | 7¾"×14¼" | 195mm×360mm | 0.60 | 0.43 | 0.23 | |
| WMDS.240-320 | 9²⁄₅"×12³⁄₅" | 240mm×320mm | 1.94 | 0.46 | 0.24 | |
| WMDS.250-400 | 9⁴⁄₅"×15¾" | 250mm×400mm | 3.34 | 0.48 | 0.26 | |
| WMDS.300-400 | 11⁴⁄₅"×15¾" | 300mm×400mm | 3.34 | 0.69 | 0.30 | |
| WMDS.390-400 | 15³⁄₁₀"×15¾" | 390mm×400mm | 3.34 | 0.80 | 0.32 | |
| WMDS.500-600 | 19⁷⁄₁₀"×23³⁄₅" | 500mm×600mm | 3.34 | 1.03 | 0.48 | |
| Sterilization Roll | ||||||
| WMDR.055-200 | 2⅕" | 55mm×200m | 0.07 | 0.03 | 0.003 | |
| WMDR.075-200 | 3" | 75mm×200m | 0.09 | 0.05 | 0.004 | |
| WMDR.100-200 | 4" | 100mm×200m | 0.14 | 0.13 | 0.11 | |
| WMDR.150-200 | 6" | 150mm×200m | 0.55 | 0.53 | 0.50 | |
| WMDR.200-200 | 8" | 200mm×200m | 0.60 | 0.58 | 0.55 | |
| WMDR.250-200 | 10" | 250mm×200m | 1.06 | 1.05 | 0.62 | |
| WMDR.350-200 | 12" | 300mm×200m | 0.60 | 0.58 | 0.55 | |
| WMDR.300-200 | 14" | 350mm×200m | 1.06 | 1.05 | 0.62 | |
| WMDR.400-600 | 16" | 400mm×200m | 1.08 | 1.06 | 0.63 |
Page 9
6.0 Technological Characteristic Comparison Table
Table 2 Comparison of Technology Characteristics
| Item | Subject Device | Predicate Device | Comparison Analysis |
|---|---|---|---|
| Product Name | Self-Seal Sterilization Pouch And Roll | Sterilization Pouch and Roll | ---- |
| 510(k) No. | K251177 | K221875 | ---- |
| Product Code | FRG,JOJ | FRG,JOJ | Same |
| Regulation No. | 21 CFR 880.685021 CFR 880.2800 | 21 CFR 880.685021 CFR 880.2800 | Same |
| Class | II | II | Same |
| Intended Use | The Self-Seal 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 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 Self-Seal Sterilization Pouch and Roll are made with medical grade paper and medical compound film. The Self Sealing Sterilization Pouch and 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 changes from red before sterilization to brown after sterilization. The steam sterilization indicator color changes from blue before sterilization to greenish black after sterilization. | 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℃).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 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 Prink before sterilization to Yellow after sterilization. The steam sterilization indicator | Similar |
Page 10
| Item | Subject Device | Predicate Device | Comparison Analysis |
|---|---|---|---|
| color change from Blue before sterilization to Dark Grey after sterilization. | |||
| Material Composition | Composed of medical grade paper and medical compound film, EO and Steam Process Indicator | Composed of medical grade paper and medical compound film, EO and Steam Process Indicator | Same |
| 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℃). | Different |
| Configuration/Dimension | Various Size, Heat Sealing | Various Size, Heat Sealing | Same |
Performance Testing
| Item | Subject Device | Predicate Device | Comparison Analysis |
|---|---|---|---|
| Sterilant Penetration Efficacy | 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 | Same |
| Device Design of Steam CI | The color of Chemical Indicator changes from Blue to dark greenish black, when exposed to Steam | The color of Chemical Indicator changes from Blue to dark grey, when exposed to Steam | Similar |
| Device Design of EO gas CI | The color of Chemical Indicator changes from red to brown, when exposed to EO gas | The color of Chemical Indicator changes from Pink to Yellow, when exposed to EO gas | Similar |
| Thickness Variations (mm) ASTM F 2251 | Passed | Passed | Same |
| Tensile strength ISO 1924-2 | Passed | Passed | Same |
| Burst Strength (kPa) ASTM F1140 ; ISO 11607-1 | Passed | Passed | Same |
| Leak Test ASTM-F2096 | Passed | Passed | |
| Seal Peel Test (N/15mm) ASTM F88/F88M ; ISO 11607-1 | Passed | Passed | Same |
| Dye penetration Test ASTM F1929 ; ISO11607-1 | No Infiltration Passed | No Infiltration Passed | Same |
| Microbial Barrier | Passed | Passed | Same |
Page 11
| Item | Subject Device | Predicate Device | Comparison Analysis |
|---|---|---|---|
| Test | |||
| End point stability testing results | 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.The color of chemical indicator for EO sterilization indicator ink is Brown, 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 Red, and the color of chemical indicator for steam sterilization indicator ink is dark greenish 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 Blue after 5 year shelf life before sterilization.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 Pink, and the color of chemical indicator for steam sterilization indicator ink is Dark Grey after steam sterilized and 24 months shelf life. | SimilarSimilarSimilar |
| Maintenance of Sterility | 6 months | 24 months | Different |
| Shelf Life | 3 years from date of manufacture for EO and Steam Indicators | 5 years from date of manufacture for EO and Steam Indicators | Different |
| Biocompatibility | Conform with ISO10993-1 (ISO10993-4, ISO10993-5, ISO10993-10, ISO10993-11, ISO10993-23) | Conform with ISO10993-1 (ISO10993-4, ISO10993-5, ISO10993-10, ISO10993-11) | Same |
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 material composition, 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 chemical indicator color, sterilization cycle parameters and shelf life. The following briefly discusses these differences:
Color differences of chemical indicators:
Property: The color change of the indicator is a visual indication, and it falls under the category of appearance characteristics.
The color differences do not alter the core function of the indicator, which is to indicate exposure to a specific sterilization process (EO or steam) through clear, distinct, and observable color changes. Both color systems comply with the
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requirements of ISO 11140-1 for chemical indicators and provide equivalent process monitoring capabilities. Users only need to interpret them according to the instructions on the respective equipment labels, without causing confusion or misjudgment.
Differences in sterilization cycle parameters:
The subject device has undergone independent sterilization process verification 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.
Difference between shelf life:
Properties: 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.
The identified differences (indicator color, specific sterilization parameters, declaration period) are non-core characteristics or process adjustments supported by sufficient verification, nor do they change the basic nature or intended use of the equipment.
7.0 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 test results demonstrated the subject device is confirmed to be safe and effective for the intended use. The conducted tests listed as below:
Table 3 Summary of Non-Clinical Testing
| Test | Test Method | Acceptance Criteria | Results |
|---|---|---|---|
| Sterilization process validation | ISO 11135:2014 | Ethylene oxide: 4 hours at 132 ℃; relative humidity between 30%- 90%; ethylene oxide concentration is 800 mg/L, 7days aeration time at room temperature. SAL=10⁻⁶ | Pass |
| ISO 17665-1:2006; ISO TS 17665-2:2009 | Steam; 4 minutes at 132℃; 20 minutes dry time. SAL=10⁻⁶ | Pass |
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| Test | Test Method | Acceptance Criteria | Results |
|---|---|---|---|
| EO Residuals | ISO 10993-7:2008 | EO ≤ 4 mg/deviceECH ≤ 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
| Test | Test Method | Acceptance Criteria | Results |
|---|---|---|---|
| Thickness | ASTM F2251-2013(2023) | Plastic: 52μm±15%Paper: 90μm±15% | Pass |
| Tensile Strength | ISO 1924-2:2008 | MD: ≥4.4kN/mCD: ≥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. |
| Dye Penetration | ASTM F1929-2023 | No channel or seal leak | Pass.No dye penetration was observed in the seal area. |
| Leak Test (Bubble) | ASTM F2096-11:2019 | No leakage | Pass.No gross leaks were detected. |
| Microbial Barrier | ASTM F1608-2021 | LRV ≥ 1.0 | Pass.The Log Reduction Value (LRV) was greater than 1.0. |
Chemical Indicator
| Test | Test Method | Acceptance Criteria | Results |
|---|---|---|---|
| Chemical Indicator | ISO 11140-1:2014Premarket Notification [510(k)] Submissions for Chemical Indicators - Guidance for Industry and FDA Staff | FDA | Color change to endpointSteam sterile:The color of Chemical Indicator changes from Blue to dark greenish black, when exposed to Steam;EO sterile:The color of Chemical Indicator changes from red to brown, 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. | Pass |
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| Test | Test Method | Acceptance Criteria | Results |
|---|---|---|---|
| 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. |
Shelf Life & Maintenance
| Test | Test Method | Acceptance Criteria | Results |
|---|---|---|---|
| Shelf Life | ASTM F1980-21 | Maintain integrity after 3-year aging | Pass.Physical properties (Seal strength, Burst, Dye penetration) met acceptance criteria after 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. |
8.0 Summary of Clinical Testing
No clinical study is included in this submission.
9.0 Conclusion
The conclusions drawn from the non-clinical tests demonstrate that the subject device (Self-Seal Sterilization Pouch and Roll) is as safe, as effective, and performs as well as or better than the predicate device K221875.
§ 880.6850 Sterilization wrap.
(a)
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.(b)
Classification. Class II (performance standards).