(270 days)
Chex-All® Sterilization Pouches and Tubes are intended to be used to enclose another medical device, in a single or double pouch configuration, that is to be sterilized by a health care provider using:
Hospital size sterilizer cycles
- Gravity steam at 121°C (250°F) for 30 minutes; 25 minutes dry time
- Pre-vacuum steam at 132°C (270°F) for 4 minutes; 20 minutes dry time
- Pre-vacuum steam at 135°C (275°F) for 3 minutes; 16 minutes dry time
Tabletop sterilizer cycles:
- Pre-vacuum steam at 132°C (270°F) for 4 minutes; 30 minutes dry time
Ethylene Oxide sterilization cycles:
- Ethylene Oxide (EO) with a concentration of 736 mg/L at 55°C (131°F) and 50% to 60% relative humidity for 60 minutes. Aeration time of 8 hours at 60°C (140°F).
Chex-All sterilization pouches and tubes can be used for steam sterilization of devices with lumens at maximum load as the following:
Metal lumen: 7 inch long, 3.2mm internal diameter
Plastic lumen: 5 inch long, 2.0 mm internal diameter.
Suitable Lumen cycles:
Hospital size sterilizers: pre-vacuum cycles with 132°C-4.0 min exposure (20 minutes dry time) and 135°C-3.0 min exposure (16 minutes dry time).
Table-top sterilizers: pre-vacuum cycle with 132°C-4.0 min exposure (30 minutes dry time).
Chex-All sterilization pouches and tubes can be used for steam sterilization in double pouch configuration, in gravity 250°F-30 min exposure cycles (25 minutes dry time) and in pre-vacuum 270°F-4 min exposure cycles (20 minutes dry time).
The Process chemical indicators on the Chex-All sterilization pouches and tubes are intended to demonstrate that the device has been exposed to the steam or EO sterilization process and to distinguish between processed and unprocessed pouches. The chemical indicators change from crème to gray/black after exposure to steam and from beige-pink to green after exposure to ethylene oxide.
If stored according to the recommended conditions, the products before sterilization have a maximum shelf life of 2 years from the date of manufacture. The pouches are intended to allow sterilization of the enclosed medical device(s) and to maintain sterility (SAL≥10-6). The subject device is intended and has been validated to maintain sterility of the enclosed devices for 30 months after steam sterilization and 12 months after EO sterilization.
The maximum pouch load is 2.65 lb. (1.2 kg) or less. The maximum pouch load for table-top sterilizers is 1.10 lb. (0.5 kg) or less. The maximum pouch size for use in table-top sterilizers is 13"x18".
The Chex-All® Sterilization pouches and tubes are made from a medical grade porous paper thermally sealed to a plastic film on the left, right, and bottom of the pouch. The top side is open to insert medical devices to be sterilized and to seal the pouch. They are available either pre-manufactured self-seal or heat-seal sizes or in a roll of heat-seal tubing for the customer to cut the pouches to their required size.
The pouches also contain chemical process indicators used to demonstrate that the pouches have been a subject of either a steam or ethylene oxide sterilization process.
All Chex-All sterilization pouches and tubes are flat and include the following products: Chex-All Heat-seal sterilization pouch, flat; Chex-All Heat-seal sterilization tube, flat, sold in rolls; Chex-All II Self-seal sterilization pouch, flat; Chex-All III Self-seal sterilization pouch, flat.
N/A
FDA 510(k) Clearance Letter - Chex-All® Sterilization Pouches and Tubes
Page 1
U.S. Food & Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
www.fda.gov
Doc ID # 04017.08.00
October 31, 2025
Propper Manufacturing Co, Inc.
Andrew Sharavara
Chief Technical Officer
36-04 Skillman Avenue
Long Island City, New York 11101
Re: K250306
Trade/Device Name: Chex-All® Sterilization Pouches and Tubes
Regulation Number: 21 CFR 880.6850
Regulation Name: Sterilization Wrap
Regulatory Class: Class II
Product Code: FRG, JOJ
Dated: January 31, 2025
Received: February 3, 2025
Dear Andrew Sharavara:
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
K250306 - Andrew Sharavara 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
K250306 - Andrew Sharavara 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: 2025.10.31 16:42:53 -04'00'
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 (6/20) Page 1 of 3
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120
Expiration Date: 06/30/2023
See PRA Statement below.
510(k) Number (if known): K250306
Device Name: Chex-All® Sterilization pouches and tubes
Indications for Use (Describe)
Indications for use:
Chex-All® Sterilization Pouches and Tubes are intended to be used to enclose another medical device, in a single or double pouch configuration, that is to be sterilized by a health care provider using:
Hospital size sterilizer cycles
- Gravity steam at 121°C (250°F) for 30 minutes; 25 minutes dry time
- Pre-vacuum steam at 132°C (270°F) for 4 minutes; 20 minutes dry time
- Pre-vacuum steam at 135°C (275°F) for 3 minutes; 16 minutes dry time
Tabletop sterilizer cycles:
- Pre-vacuum steam at 132°C (270°F) for 4 minutes; 30 minutes dry time
Ethylene Oxide sterilization cycles:
- Ethylene Oxide (EO) with a concentration of 736 mg/L at 55°C (131°F) and 50% to 60% relative humidity for 60 minutes. Aeration time of 8 hours at 60°C (140°F).
Chex-All sterilization pouches and tubes can be used for steam sterilization of devices with lumens at maximum load as the following:
Metal lumen: 7 inch long, 3.2mm internal diameter
Plastic lumen: 5 inch long, 2.0 mm internal diameter.
Suitable Lumen cycles:
Hospital size sterilizers: pre-vacuum cycles with 132°C-4.0 min exposure (20 minutes dry time) and 135°C-3.0 min exposure (16 minutes dry time).
Table-top sterilizers: pre-vacuum cycle with 132°C-4.0 min exposure (30 minutes dry time).
Chex-All sterilization pouches and tubes can be used for steam sterilization in double pouch configuration, in gravity 250°F-30 min exposure cycles (25 minutes dry time) and in pre-vacuum 270°F-4 min exposure cycles (20 minutes dry time).
The Process chemical indicators on the Chex-All sterilization pouches and tubes are intended to demonstrate that the device has been exposed to the steam or EO sterilization process and to distinguish between processed and unprocessed pouches. The chemical indicators change from crème to gray/black after exposure to steam and from beige-pink to green after exposure to ethylene oxide.
If stored according to the recommended conditions, the products before sterilization have a maximum shelf life of 2 years from the date of manufacture. The pouches are intended to allow sterilization of the enclosed medical device(s) and to maintain sterility (SAL≥10-6). The subject device is intended and has been validated to maintain sterility of the enclosed devices for 30 months after steam sterilization and 12 months after EO sterilization.
The maximum pouch load is 2.65 lb. (1.2 kg) or less. The maximum pouch load for table-top sterilizers is 1.10 lb. (0.5 kg) or less. The maximum pouch size for use in table-top sterilizers is 13"x18".
Page 5
FORM FDA 3881 (6/20) Page 2 of 3
The following tables list the available model numbers of the Chex-All sterilization pouches and tubes.
| Cat. Numbers | External Dimensions | Max load weight |
|---|---|---|
| Width | Length |
Chex-All Heat-seal sterilization pouch, flat
| 02500800 | 3" | 8" | 0.99 |
| 02501000 | 5" | 10" | 0.99 |
| 02501200 | 7" | 12" | 1.10 |
| 02501400 | 8" | 16" | 1.10 |
| 02501800 | 12" | 18" | 2.65 |
| 02502400 | 18" | 24" | 2.65 |
Chex-All Heat-seal sterilization tube, flat, sold in rolls
| 02600200 | 2" | 100' | 0.99 |
| 02600300 | 3" | 100' | 0.99 |
| 02600400 | 4" | 100' | 0.99 |
| 02600600 | 6" | 100' | 1.10 |
| 02600900 | 9" | 100' | 1.10 |
| 02601200 | 12" | 100' | 2.65 |
Chex-All II Self-seal sterilization pouch, flat
| 02400800 | 3" | 8" | 0.99 |
| 02401000 | 5" | 10" | 0.99 |
| 02401200 | 7" | 12" | 1.10 |
| 02401400 | 8" | 16" | 1.10 |
| 02401500 | 5" | 15" | 0.99 |
| 02401800 | 12" | 18" | 2.65 |
| 02402800 | 3.5" | 24" | 0.99 |
Chex-All III Self-seal sterilization pouch, flat
| 02430900 | 3.5" | 9.5" | 0.99 |
| 02431000 | 5.25" | 10" | 0.99 |
| 02431300 | 7.5" | 12" | 1.10 |
| 02431400 | 9" | 16" | 1.10 |
| 02431800 | 13" | 18" | 2.65 |
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.
Page 6
FORM FDA 3881 (6/20) Page 3 of 3
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 7
Page 1 (K250306)
510(k) Summary (K250306)
Submitted by: Propper Manufacturing Company, Inc.
Address: 36-04 Skillman Avenue,
Long Island City, New York 11101
Contact Name: Andrew Sharavara, Ph.D., Chief Technical Officer
Telephone: (800) 832-4300 x149
Fax: (718) 482-8909
E-mail: as@proppermfg.com
Date Submitted: October 31, 2025
Device information:
Device Trade Name: Chex-All® Sterilization Pouches and Tubes
Classification Name: Sterilization wrap
Common Name: Sterilization pouch
Product Code: FRG, JOJ
Classification: Class II (21 C.F.R. 880.6850, 21 C.F.R. 880.2800)
Predicate Device: K153540
Description of the Device
The Chex-All® Sterilization pouches and tubes are made from a medical grade porous paper thermally sealed to a plastic film on the left, right, and bottom of the pouch. The top side is open to insert medical devices to be sterilized and to seal the pouch. They are available either pre-manufactured self-seal or heat-seal sizes or in a roll of heat-seal tubing for the customer to cut the pouches to their required size.
The pouches also contain chemical process indicators used to demonstrate that the pouches have been a subject of either a steam or ethylene oxide sterilization process.
All Chex-All sterilization pouches and tubes are flat and include the following products:
| Category name | Type | Steam and EO Indicator | Cat. Numbers | External Dimensions | Max load, lb |
|---|---|---|---|---|---|
| Width | Length | ||||
| Chex-All pouches | Heat-seal sterilization pouch, flat | External, Internal | 02500800 | 3" | 8" |
| 02501000 | 5" | 10" | |||
| 02501200 | 7" | 12" | |||
| 02501400 | 8" | 16" | |||
| 02501800 | 12" | 18" | |||
| 02502400 | 18" | 24" | |||
| Chex-All tubes | Heat-seal sterilization | External, Internal | 02600200 | 2" | 100' |
| 02600300 | 3" | 100' |
Page 8
Page 2 (K250306)
| tube, flat, sold in rolls | 02600400 | 4" | 100' | 0.99 | ||
|---|---|---|---|---|---|---|
| 02600600 | 6" | 100' | 1.10 | |||
| 02600900 | 9" | 100' | 1.10 | |||
| 02601200 | 12" | 100' | 2.65 | |||
| Chex-All II pouches | Self-seal sterilization pouch, flat | External, Internal | 02400800 | 3" | 8" | 0.99 |
| 02401000 | 5" | 10" | 0.99 | |||
| 02401200 | 7" | 12" | 1.10 | |||
| 02401400 | 8" | 16" | 1.10 | |||
| 02401500 | 5" | 15" | 0.99 | |||
| 02401800 | 12" | 18" | 2.65 | |||
| 02402800 | 3.5" | 24" | 0.99 | |||
| Chex-All III pouches | Self-seal sterilization pouch, flat | External | 02430900 | 3.5" | 9.5" | 0.99 |
| 02431000 | 5.25" | 10" | 0.99 | |||
| 02431300 | 7.5" | 13" | 1.10 | |||
| 02431400 | 9" | 16" | 1.10 | |||
| 02431800 | 13" | 18" | 2.65 |
Indications for Use
Chex-All® Sterilization Pouches and Tubes are intended to be used to enclose another medical device, in a single or double pouch configuration, that is to be sterilized by a health care provider using:
Hospital size sterilizer cycles
- Gravity steam at 121°C (250°F) for 30 minutes; 25 minutes dry time
- Pre-vacuum steam at 132°C (270°F) for 4 minutes; 20 minutes dry time
- Pre-vacuum steam at 135°C (275°F) for 3 minutes; 16 minutes dry time
Tabletop sterilizer cycles:
- Pre-vacuum steam at 132°C (270°F) for 4 minutes; 30 minutes dry time
Ethylene Oxide sterilization cycles:
- Ethylene Oxide (EO) with a concentration of 736 mg/L at 55°C (131°F) and 50% to 60% relative humidity for 60 minutes. Aeration time of 8 hours at 60°C (140°F).
Chex-All sterilization pouches and tubes can be used for steam sterilization of devices with lumens at maximum load as the following:
Metal lumen: 7 inch long, 3.2mm internal diameter
Plastic lumen: 5 inch long, 2.0 mm internal diameter.
Suitable Lumen cycles:
Hospital size sterilizers: pre-vacuum cycles with 132°C-4.0 min exposure (20 minutes dry time) and 135°C-3.0 min exposure (16 minutes dry time).
Table-top sterilizers: pre-vacuum cycle with 132°C-4.0 min exposure (30 minutes dry time).
Page 9
Page 3 (K250306)
Chex-All sterilization pouches and tubes can be used for steam sterilization in double pouch configuration, in gravity 250°F-30 min exposure cycles (25 minutes dry time) and in pre-vacuum 270°F-4 min exposure cycles (20 minutes dry time).
The Process chemical indicators on the Chex-All sterilization pouches and tubes are intended to demonstrate that the device has been exposed to the steam or EO sterilization process and to distinguish between processed and unprocessed pouches. The chemical indicators change from crème to gray/black after exposure to steam and from beige-pink to green after exposure to ethylene oxide.
If stored according to the recommended conditions, the products before sterilization have a maximum shelf life of 2 years from the date of manufacture. The pouches are intended to allow sterilization of the enclosed medical device(s) and to maintain sterility (SAL ≥ 10-6). The subject device is intended and has been validated to maintain sterility of the enclosed devices for 30 months after steam sterilization and 12 months after EO sterilization.
The maximum pouch load is 2.65 lb. (1.2 kg) or less. The maximum pouch load for table-top sterilizers is 1.10 lb. (0.5 kg) or less. The maximum pouch size for use in table-top sterilizers is 13"x18".
The following tables list the available model numbers of the Chex-All sterilization pouches and tubes.
| Category name and type | Cat. Numbers | External Dimensions | Max load, lb |
|---|---|---|---|
| Width | Length | ||
| Chex-All Heat-seal sterilization pouch, flat | 02500800 | 3" | 8" |
| 02501000 | 5" | 10" | |
| 02501200 | 7" | 12" | |
| 02501400 | 8" | 16" | |
| 02501800 | 12" | 18" | |
| 02502400 | 18" | 24" | |
| Chex-All Heat-seal sterilization tube, flat, sold in rolls | 02600200 | 2" | 100' |
| 02600300 | 3" | 100' | |
| 02600400 | 4" | 100' | |
| 02600600 | 6" | 100' | |
| 02600900 | 9" | 100' | |
| 02601200 | 12" | 100' | |
| Chex-All II Self-seal sterilization pouch, flat | 02400800 | 3" | 8" |
| 02401000 | 5" | 10" | |
| 02401200 | 7" | 12" | |
| 02401400 | 8" | 16" | |
| 02401500 | 5" | 15" | |
| 02401800 | 12" | 18" | |
| 02402800 | 3.5" | 24" | |
| Chex-All III Self-seal sterilization pouch, flat | 02430900 | 3.5" | 9.5" |
| 02431000 | 5.25" | 10" | |
| 02431300 | 7.5" | 13" | |
| 02431400 | 9" | 16" | |
| 02431800 | 13" | 18" |
Page 10
Page 4 (K250306)
Summary of Device Technological Characteristics with Comparison to the Predicate Device
| Predicate Device, K153540 | Subject Device, K250306 | Comparison | |
|---|---|---|---|
| Manufacturer | Safe Secure Packaging Co. | Propper Manufacturing Co., Inc. | N/A |
| Class of Medical Device | II | II | Identical |
| Code | FRG | FRG, JOJ | Identical |
| Regulation | 21 CFR 880.6850 | 21 CFR 880.6850 | Identical |
| Product name | Sterilization Pouch with Steam and EO Process Indicators | Chex-All Sterilization Pouches and Tubes | Similar |
| Type of packaging device | Flat pouch and roll (tube) | Flat pouch and roll (tube) | Identical |
| Pouch dimensions | Length 8-25.5", Width 3-18" | Length 8-24", Width 3-18" | Similar |
| Tube roll dimensions | Width 2-12", 100 Ft length | Width 2-12", 100 Ft length | Identical |
| Single use | Yes | Yes | Identical |
| Indications for use | Safe Secure Paper Sterilization Pouches and Rolls are intended to be used to enclose another medical device, in a single or double pouch configuration, that is to be sterilized by a health care provider using:•Gravity Steam at 121°C (250°F) for 30 minutes, 25 min dry time•Pre-vacuum Steam at 132°C (270°F) for 4 minutes, 20 min dry time•Pre-vacuum Steam at 134°C (273°F) for 3 minutes, 20 min dry time•Pre-vacuum steam at 135°C (275°F) for 3 minutes, 16 min dry time•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). | Chex-All® Sterilization Pouches and Tubes are intended to be used to enclose another medical device, in a single or double pouch configuration, that is to be sterilized by a health care provider using:Hospital size sterilizer cyclesGravity steam at 121°C (250°F) for 30 minutes; 25 minutes dry timePre-vacuum steam at 132°C (270°F) for 4 minutes; 20 minutes dry timePre-vacuum steam at 135°C (275°F) for 3 minutes; 16 minutes dry timeTabletop sterilizer cycles:Pre-vacuum steam at 132°C (270°F) for 4 minutes; 30 minutes dry timeEthylene Oxide sterilization cycles:• Ethylene Oxide (EO) with a concentration of 736 mg/L at 55°C (131°F) and 50% to 60% relative humidity for 60 minutes. Aeration time of 8 hours at 60°C (140°F). | Intended use: identicalCycles: similar |
Page 11
Page 5 (K250306)
| Predicate Device, K153540 | Subject Device, K250306 | Comparison | |
|---|---|---|---|
| The device is not intended and has not been validated for sterilization of devices that contain lumens.The external chemical indicators on the pouches/rolls are intended to demonstrate that the device has been exposed to the Steam or EO sterilization process and to distinguish between processed and unprocessed devices. The chemical indicators change from green to purple after exposure to steam and from yellow to brown after exposure to ethylene oxide.If stored according to the recommended conditions, the products before sterilization have a maximum shelf life of 5 years from the date of manufacture.The pouches are intended to allow sterilization of the enclosed medical device(s) and also, to maintain sterility (SAL=10-6).The subject device is intended and has been validated to maintain sterility of the enclosed device for 6 months after steam sterilization and 24 months after EO sterilization. | Chex-All sterilization pouches and tubes can be used for steam sterilization of devices with lumens at maximum load as the following:Metal lumen: 7 inch long, 3.2mm internal diameter Plastic lumen: 5 inch long, 2.0 mm internal diameter.Suitable Lumen cycles:Hospital size sterilizers: pre-vacuum cycles with 132°C-4.0 min exposure (20 minutes dry time) and 135°C-3.0 min exposure (16 minutes dry time). Table-top sterilizers: pre-vacuum cycle with 132°C-4.0 min exposure (30 minutes dry time).Chex-All sterilization pouches and tubes can be used for steam sterilization in double pouch configuration, in gravity 250°F-30 min exposure cycles (25 minutes dry time) and in pre-vacuum 270°F-4 min exposure cycles (20 minutes dry time).The Process chemical indicators on the Chex-All sterilization pouches and tubes are intended to demonstrate that the device has been exposed to the steam or EO sterilization process and to distinguish between processed and unprocessed pouches. The chemical indicators change from crème to gray/black after exposure to steam and from beige-pink to green after exposure to ethylene oxide.If stored according to the recommended conditions, the products before sterilization have a maximum shelf life of 2 years from the date of manufacture. The pouches are intended to allow sterilization of the enclosed medical device(s) and to maintain sterility (SAL ≥ 10-6). The subject device is intended and has been validated to maintain sterility of the enclosed devices for 30 months after steam sterilization and 12 months after EO sterilization. | Use with lumen devices: differentIntended use of process indicators: identicalColor change of indicators: differentShelf life: similarSterility: identicalSterility maintenance Similar |
Page 12
Page 6 (K250306)
| Predicate Device, K153540 | Subject Device, K250306 | Comparison | |
|---|---|---|---|
| The maximum validated pouch load is 2.64 pounds (1.2kg). | The maximum pouch load is 2.65 lb. (1.2 kg) or less. The maximum pouch load for table-top sterilizers is 1.10 lb. (0.5 kg) or less. The maximum pouch size for use in table-top sterilizers is 13x18". | Max load weight: identical | |
| Material composition | Porous paper or Tyvek, PET/CPP high-temperature blue compound film, high temperature adhesive paper, medical double side Tape, EO gas indicator ink, Steam indicator ink | Porous paper, PET/CPP high-temperature clear compound film, high temperature paper, medical double side Tape, EO gas indicator ink, Steam indicator ink | Identical except for film color and Tyvek |
| Air permeance | The maximum equivalent pore size diameter shall not exceed 50 um | The maximum equivalent pore size diameter shall not exceed 50 um | Identical |
| Shelf life before sterilization | 5 years | 2 years | Similar |
| Shelf life after sterilization | 6 months after steam sterilization (gravity or pre-vacuum), or 24 months after EO sterilization. | 30 months after steam sterilization (gravity or pre-vacuum), or 12 months after EO sterilization. | Similar |
| Film Thickness | Film: +0.002 mm | Film: +0.002 mm | Identical |
| Seal strength before sterilization | 2.5-5.5N/15mm | 2.5 N/15mm-5.5 N/15mm | Identical |
| Burst Strength | 2.5-5.5N/15mm | 390-400 kPa. | Different units |
| Peel-open | No splitting of paper more than 10 mm from heat seal lines. | Conform to 5.1.9 d) of AAMI/ISO 11607-1:2019 | Similar |
| Tensile Strength | Paper ≥220N/50mm | Paper ≥4.40 kN/m (≥220N/50mm) | Identical |
| Seal integrity | Visual examination of the seal area through the transparent side of the package shows no channels present | Visual examination of the seal area through the transparent side of the package shows no channels present | Identical |
| Seal width | More than 8 mm | More than 8 mm | Identical |
| EO residues limits | Less than 1 mg/pouch/day | Less than 1 mg/pouch/day | Identical |
| Indicator color change | Steam sterilization: Green to purpleEO sterilization: yellow to brown | Steam sterilization: crème to gray/blackEO sterilization: beige-pink to green | Different |
| Indicator purpose | Designed to work as process indicators to distinguish between unprocessed and processed items after steam and EO Gas exposure. | Designed to work as process indicators to distinguish between unprocessed and processed items after steam and EO Gas exposure. | Identical |
Page 13
Page 7 (K250306)
Summary of non-clinical testing
Provided below is the summary of non-clinical testing that was performed to demonstrate that Chex-All sterilization pouches and tubes met the acceptance criteria for each standard or test method.
| Parameter | Standard | Acceptance criteria | Results |
|---|---|---|---|
| Tensile strength MD | ISO 1924-2 | Not less than 4,40 kN/m | Pass |
| Tensile strength CD | ISO 1924-2 | Not less than 2,20 kN/m | Pass |
| Wet Tensile Strength MD | ISO 3781 | Not less than 0,90 kN/m | Pass |
| Wet Tensile Strength CD | ISO 3781 | Not less than 0,45 kN/m | Pass |
| Burst strength | ISO 2758 | Not less than 230 kPa | Pass |
| Paper wet burst strength | ISO 3689 | Not less than 35 kPa | Pass |
| Paper chlorides | ISO 9197 | Less than 0.05% | Pass |
| Paper sulphates | ISO 9198 | Less than 0.25% | Pass |
| Tensile Strength (MD) N/15mm | ASTM D882 | Not less than 20N/15mm | Pass |
| Tensile Strength (CD) N/15mm | ASTM D882 | Not less than 20N/15mm | Pass |
| Testing for microbial barrier | DIN 58953-6 | CFU=0 | Pass |
| Dye penetration test-seal | ASTM F1929 | No leaks in edge seals | |
| Seal strength | ASTM F88 | Not less than 1,5N/15mm | Pass |
| Shelf life | Real time 2 years exposure | Must pass performance tests | Pass |
| Integrity of seals - visual | ASTM F1886 | No visible seal defects | Pass |
| Peel-open characteristics | ISO 11607-1 | As per 5.1.9 d) | Pass |
| Sterility maintenance | 30- and 12- months real time exposure of sterilized pouches Ref. USP | No microbial growth | Pass |
| Sterilant penetration and attainment of sterility in hospital Steam sterilization cycles | ANSI/AAMI/ISO 17665-1:2006/(R)2013, Annex D. Loaded pouches, half cycle | No spore growth | Pass |
| Sterilant penetration and attainment of sterility in tabletop Steam sterilization cycles | ANSI/AAMI/ISO 17665-1:2006/(R)2013, Annex D. Loaded pouches, full cycle | No spore growth | Pass |
| Sterilant penetration and attainment of sterility in EO cycles | ANSI/AAMI/ISO 14937: 2009/(R)2013. Loaded pouches, USP protocol | No spore growth | Pass |
| Double-pouch packaging in steam cycles | AAMI/ST-79:2017/(R)2022, 9.5.4. | No spore growth | Pass |
| Drying time | ISO/TS 17665-2:2009, Annex A | Cut-off - no greater than 0.2%. | Pass |
Page 14
Page 8 (K250306)
| Steam penetration - lumen devices. Hospital and table-top steam sterilizers, pre-vacuum cycles | Half-cycle test in hospital sterilizer and full cycle test in table-top sterilizer, USP protocol | No spore growth | Pass |
|---|---|---|---|
| Steam indicator | FDA guidance for industry and FDA Staff: Pre-market notification [510(k)] submissions for chemical indicators, 2003 | Performance criteria for Process indicators | Pass |
| Steam indicator | FDA guidance for industry and FDA Staff: Pre-market notification [510(k)] submissions for chemical indicators, 2003, Typical approved cycle | Color change in cycles used in healthcare | Pass |
| Steam indicator | Ink transference | Pass | |
| EO indicator | ISO 11140-1:2014., 7.2 | Performance criteria for Process indicators | Pass |
| EO indicator | FDA guidance for industry and FDA Staff: Pre-market notification [510(k)] submissions for chemical indicators, 2003, Typical approved cycle | Color change in cycles used in healthcare | Pass |
| EO indicator | ISO 11140-1:2014., 7.2 | Ink transference | Pass |
Conclusion
The conclusion drawn from the nonclinical test demonstrates that the Chex-All sterilization pouches and tubes are as safe, as effective, and perform as well as or better than the legally marketed predicate device, K153540.
§ 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).