Dukal SMS Sterilization Wrap

K233262 · Dukal, LLC · FRG · Mar 22, 2024 · General Hospital

Device Facts

• Record ID: K233262
• Device Name: Dukal SMS Sterilization Wrap
• Applicant: Dukal, LLC
• Product Code: FRG · General Hospital
• Decision Date: Mar 22, 2024
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.6850
• Device Class: Class 2

Intended Use

The Dukal SMS sterilization wraps are intended to be used to enclose another medical device that is to be sterilized by a healthcare provider using: · In a steam sterilization pre-vacuum cycle at 270°F / 132°C for 4 minutes o Models 100, 200 and 300 were validated for dry times of 20 minutes: models 400, 500 and 600 were validated for dry times of 30 minutes. · In 100% ethylene oxide (EO) with a concentration of 725-735 mg/L at 131°F / 55°C and 40-80% relative humidity for 60 minutes. o The wrap was validated for aeration times for EO sterilization of 16 hours at 40.0 ℃. Dukal SMS sterilization wraps are intended to allow sterilization of the enclosed medical device(s), and also to maintain sterility of the enclosed device(s) for 6 months or until opened. The devices are intended for over-the-counter use and are single use disposable sterilization wraps.

Device Story

Dukal SMS Sterilization Wrap consists of blue nonwoven polypropylene fabric sheets (meltblown layer between two spunbond layers). Used by healthcare providers to wrap medical instruments prior to sterilization. Input: medical devices to be sterilized. Transformation: provides a sterile barrier allowing sterilant penetration (steam or EO) while maintaining sterility post-process. Output: wrapped, sterilized medical device package. Used in clinical settings; single-use disposable. Benefits: maintains sterility of enclosed devices for up to 6 months. Models 100-600 vary by basis weight and validated load capacity (3-25 lbs).

Clinical Evidence

No clinical data. Bench testing only. Performance validated via ISO 11607-1, ASTM F1608, and USP <71> for sterility maintenance, plus physical/mechanical testing (ASTM D3776, D5034, D5587, D3786) and biocompatibility (ISO 10993).

Technological Characteristics

Materials: Polypropylene/polyethylene nonwoven SMS (Spunbond-Meltblown-Spunbond) fabric. Thermal bonding (square inch pattern). Dimensions: 9x9" to 60x60". Connectivity: N/A. Sterilization: Steam (pre-vacuum) or Ethylene Oxide. Standards: ISO 11607-1, ISO 10993, ASTM D3776, D737, D3786, D5034, D5587, D257, D4966, AATCC 127, 193, ASTM F2101, F1608.

Indications for Use

Indicated for use by healthcare providers to enclose medical devices for sterilization via pre-vacuum steam (270°F/132°C, 4 min) or 100% ethylene oxide (725-735 mg/L, 131°F/55°C, 60 min). Intended for over-the-counter use to maintain sterility of enclosed devices for 6 months.

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

• Kimguard Sterilization wrap (K082554)
• Kimguard One-Step Sterilization Wrap (K143053)

Submission Summary (Full Text)

{0}------------------------------------------------

Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

March 22, 2024

Dukal LLC Megan Quevedo Supervisor of Ouality and Regulatory Affairs 2 Fleetwood Court Ronkonkoma, New York 11779

Re: K233262

Trade/Device Name: Dukal SMS Sterilization Wrap Regulation Number: 21 CFR 880.6850 Regulation Name: Sterilization Wrap Regulatory Class: Class II Product Code: FRG Dated: February 23, 2024 Received: February 23, 2024

Dear Megan Quevedo:

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.

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"

{1}------------------------------------------------

(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 OS 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 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-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 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.

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-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

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

Sincerely.

Image /page/1/Picture/7 description: The image shows the text "Stephen A. Anisko -S" in a large, sans-serif font. The text is arranged in two lines, with "Stephen A." on the first line and "Anisko -S" on the second line. The text is black, and the background is white.

Digitally signed by Stephen A. Anisko -S Date: 2024.03.22 09:06:46 -04'00'

for Christopher Dugard Assistant Director DHT4B: Division of Infection Control and Plastic and Reconstructive Surgery Devices

{2}------------------------------------------------

OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

{3}------------------------------------------------

## Indications for Use

510(k) Number (if known) K233262

Device Name Dukal SMS Sterilization Wrap

#### Indications for Use (Describe)

The Dukal SMS sterilization wraps are intended to be used to enclose another medical device that is to be sterilized by a healthcare provider using:

· In a steam sterilization pre-vacuum cycle at 270°F / 132°C for 4 minutes

o Models 100, 200 and 300 were validated for dry times of 20 minutes: models 400, 500 and 600 were validated for dry times of 30 minutes.

· In 100% ethylene oxide (EO) with a concentration of 725-735 mg/L at 131°F / 55°C and 40-80% relative humidity for 60 minutes.

o The wrap was validated for aeration times for EO sterilization of 16 hours at 40.0 ℃.

Dukal SMS sterilization wraps are intended to allow sterilization of the enclosed medical device(s), and also to maintain sterility of the enclosed device(s) for 6 months or until opened. The devices are intended for over-the-counter use and are single use disposable sterilization wraps.

Test results validated that the Dukal SMS sterilization wraps allowed sterilization of the enclosed medical device(s) by ethylene oxide sterilization and by pre-vacuum cycles.

These models of the Dukal SMS sterilization wrap have been validated for use with the ethylene oxide and pre-vacuum cycles listed in below table:

| Type of Use (Select one or both, as applicable) | |
|-------------------------------------------------|--------------|
| | |
| Prescription Use (Part 21 CFR 801 Subpart D) | <div></div> |
| Over-The-Counter Use (21 CFR 801 Subpart C) | <div> </div> |

#### 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."

{4}------------------------------------------------

Dukal SMS Sterilization Wrap Recommendations for Use with the Pre-Vacuum Steam or Ethylene Oxide¹

| Dukal SMS<br>Sterilization Wrap<br>Models | Intended Loads | Maximum Wrapped<br>Package Content<br>Weights Used in<br>Sterility Maintenance<br>Validation Study² | Descriptions of Loads<br>Used in Sterility<br>Maintenance Validation<br>Study² |
|-------------------------------------------|------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Model 100 | Very Light Weight Package<br>(for example: towel packs<br>or batteries) | 3 lbs. | Pre-Vacuum Steam and<br>EO:<br>20 huck towels (17"x26") |
| Model 200 | Light Weight Package (for<br>example: standard linen<br>packs or telescope with<br>light cord) | 6lbs. | Pre-Vacuum Steam and<br>EO:<br>2 huck towels (17"x26")<br>2 fluid resistant U-drapes<br>(68"x109")<br>1 fluid resistant universal<br>bar drape (70"x108") |
| Model 300 | Light to Moderate Weight<br>Package (for example:<br>general use medical<br>instruments) | 9 lbs. | Pre-Vacuum Steam:<br>15 huck towels (17"x26")<br>1 small fluid resistant<br>drape (60"x76")<br>5 lbs. of metal mass<br>EO:<br>16 huck towels<br>2 fluid resistant large<br>drapes (76"x 100")<br>1 fluid resistant small<br>drape (76"x60")<br>1 fluid resistant table<br>cover (60" x 90") |
| Model 4003 | Moderate to Heavy Weight<br>Package (for example:<br>general use medical<br>instruments) | 13 lbs. | Pre-Vacuum Steam and<br>EO:<br>4 tray liners 20"x25"<br>stacked<br>10"x10"x2 1/2" tray<br>containing 11 lbs. of<br>metal mass |
| Model 5003 | Heavyweight Package (for<br>example: general use<br>medical instruments) | 17 lbs. | Pre-Vacuum Steam and<br>EO:<br>4 tray liners 20"x25"<br>stacked<br>10"x10"x2 1/2" tray<br>containing 15 lbs. of<br>metal mass |
| Model 6003 | Very Heavy Weight<br>Package (for example:<br>general use medical<br>instruments) | 25 lbs. | Pre-Vacuum Steam and<br>EO: |
| | | | 4 tray liners 20"x25"<br>stacked<br>10"x10"x2 1/2" tray<br>containing 23 lbs. of<br>metal mass |

{5}------------------------------------------------

1 Individual results may differ due to factors such as variations in handling practices, wrapping techniques, and folding methods. Results may also differ due to the use of irregularly shaped contents, which may put added stress on the wrap. Each healthcare facility should determine for itself which wrap model is most appropriate for each intended use.

² It is recommended to not exceed the maximum wrapped package content weights indicated for each wrap model. Furthermore, it is recommended to not exceed the number, weight, and size of individual content types that were validated for the Sterilization Wraps (i.e.: the number and size of the fluid resistant linens or the weight of the metal mass).

3 The 400, 500 and 600 model wraps were validated for sterilant penetration with 3 lbs. of non-fluid resistant linen, and it is recommended to not exceed 3 lbs. of non-fluid resistant linen in sterilization cycles with these models. It is recommended that the user not include fluid-resistant linens in 400, 500 and 600 model wraps, as use of such fluid resistant materials has not been evaluated with these models.

Note: The loads used in each Sterility Validation Study corresponded to the maximum wrapped package content weights in above table.

Note: The trays used for the pre-vacuum studies were not the same as those used for the EO validation. Therefore, different amounts of metal mass were used in each study to achieve the maximum recommended wrapped package content weights for each wrap model.

{6}------------------------------------------------

## K233262 510(k) SUMMARY 510(k) Premarket Notification for Dukal SMS Sterilization Wrap

| 1. Submitter: | Dukal LLC<br>2 Fleetwood Court<br>Ronkonkoma NY 11779<br>Phone: [phone]<br>Fax: [phone] |
|--------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 2. FDA Registration Number: | 2435946 |
| 3. Regulatory Affairs Contact: | Megan Quevedo<br>Quality and Regulatory Affairs Supervisor<br>2 Fleetwood Court<br>Ronkonkoma NY 11779<br>Telephone Number: 631-656-3800 ext. 133<br>Fax Number: 631-656-3810 |
| 4. Date Summary Prepared: | February 22, 2024 |
| 5. Name of Device: | Dukal SMS Sterilization Wrap |
| 6. Trade Name: | Dukal SMS Sterilization Wrap |
| 7. Common/Classification Name: | Sterilization Wrap |
| 8. Regulation Number: | 21 CFR 880.6850 |
| 9. Device Class: | Class II |
| 10. Regulation Name: | Sterilization Wrap |
| 11. Product Code: | ERG |

#### 12. Predicate Device:

- o Kimguard Sterilization wrap, models KC100, KC300, KC300, KC400, KC500 and KC600
- . K082554
- . Cleared: 05/01/2009
- Kimguard One-Step Sterilization Wrap
- K143053 .
- . Cleared: 04/03/2015

{7}------------------------------------------------

| 13. Device Description: | Models 100, 200, 300, 400, 500 and 600<br>Available in one or two sheets of blue nonwoven<br>Polypropylene fabric. Each sheet of fabric is composed<br>of three thermally- bonded layers consisting of a<br>Meltblown polypropylene layer surrounded by<br>Spunbond polypropylene layers (SMS). |
|-------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 14. Packaging: | The packaging material of the inner bag consists of<br>transparent polyethylene (PE). |

## 15. Indications for Use:

The Dukal SMS Sterilization Wraps are intended to be used to enclose another medical device that is to be sterilized by a healthcare provider using:

- . In a steam sterilization pre-vacuum cycle at 270°F / 132°C for 4 minutes
- Models 100, 200 and 300 were validated for dry times of 20 minutes; models 400, 500 O and 600 were validated for dry times of 30 minutes.
- . In 100% ethylene oxide (EO) with a concentration of 725-735 mg/L at 131°F / 55°C and 40-80% relative humidity for 60 minutes.
- o The wrap was validated for aeration times for EO sterilization of 16 hours at 40.0 °C.

Dukal SMS sterilization wraps are intended to allow sterilization of the enclosed medical device(s), and also to maintain sterility of the enclosed device(s) for 6 months or until opened. The devices are intended for over-the- counter use and are single use disposable sterilization wraps.

Test results validated that the Dukal SMS sterilization wraps allowed sterilization of the enclosed medical device(s) by ethylene oxide sterilization and by pre-vacuum cycles.

These models of the Dukal SMS sterilization wrap have been validated for use with the ethylene oxide and pre-vacuum cycles listed in below table:

### Dukal SMS Sterilization Wrap Recommendations for Use with the Pre-Vacuum Steam or Ethylene Oxide¹

| Dukal SMS<br>Sterilization Wrap<br>Models | Intended Loads | Maximum Wrapped<br>Package Content<br>Weights Used in<br>Sterility Maintenance<br>Validation Study2 | Descriptions of Loads<br>Used in Sterility<br>Maintenance Validation<br>Study2 |
|-------------------------------------------|------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Model 100 | Very Light Weight Package<br>(for example: towel packs<br>or batteries) | 3 lbs. | Pre-Vacuum Steam and<br>EO:<br>20 huck towels (17"x26") |
| Model 200 | Light Weight Package (for<br>example: standard linen<br>packs or telescope with<br>light cord) | 6 lbs. | Pre-Vacuum Steam and<br>EO:<br>2 huck towels (17"x26") |
| | | | |
| Model 300 | Light to Moderate Weight<br>Package (for example:<br>general use medical<br>instruments) | 9 lbs. | 2 fluid resistant U-drapes<br>(68"x109")<br>1 fluid resistant universal<br>bar drape (70"x108")<br>Pre-Vacuum Steam:<br>15 huck towels (17"x26")<br>1 small fluid resistant<br>drape (60"x76")<br>5 lbs. of metal mass |
| | | | EO:<br>16 huck towels<br>2 fluid resistant large<br>drapes (76"x 100")<br>1 fluid resistant small<br>drape (76"x60")<br>1 fluid resistant table<br>cover (60" x 90") |
| Model 4003 | Moderate to Heavy Weight<br>Package (for example:<br>general use medical<br>instruments) | 13 lbs. | Pre-Vacuum Steam and<br>EO:<br>4 tray liners 20"x25"<br>stacked<br>10"x10"x2 1/2" tray<br>containing 11 lbs. of<br>metal mass |
| Model 5003 | Heavyweight Package (for<br>example: general use<br>medical instruments) | 17 lbs. | Pre-Vacuum Steam and<br>EO:<br>4 tray liners 20"x25"<br>stacked<br>10"x10"x2 1/2" tray<br>containing 15 lbs. of<br>metal mass |
| Model 6003 | Very Heavy Weight<br>Package (for example:<br>general use medical<br>instruments) | 25 lbs. | Pre-Vacuum Steam and<br>EO:<br>4 tray liners 20"x25"<br>stacked<br>10"x10"x2 1/2" tray<br>containing 23 lbs. of<br>metal mass |

{8}------------------------------------------------

¹ Individual results may differ due to factors such as variations in handling practices, wrapping techniques, and folding methods. Results may also differ due to the use of irregularly shaped contents, which may put added stress on the wrap. Each healthcare facility should determine for itself which wrap model is most appropriate for each intended use.

{9}------------------------------------------------

² It is recommended to not exceed the maximum wrapped package content weights indicated for each wrap model. Furthermore, it is recommended to not exceed the number, weight, and size of individual content types that were validated for the Sterilization Wraps (i.e.: the number and size of the fluid resistant linens or the weight of the metal mass).

3 The 400, 500 and 600 model wraps were validated for sterilant penetration with 3 lbs. of non-fluid resistant linen, and it is recommended to not exceed 3 lbs. of non-fluid resistant linen in sterilization cycles with these models. It is recommended that the user not include fluid-resistant linens in 400, 500 and 600 model wraps, as use of such fluid resistant materials has not been evaluated with these models.

Note: The loads used in each Sterility Validation Study corresponded to the maximum wrapped package content weights in above table.

Note: The trays used for the pre-vacuum studies were not the same as those used for the EO validation. Therefore, different amounts of metal mass were used in each study to achieve the maximum recommended wrapped package content weights for each wrap model.

### 16. Comparison of Technological Characteristics with the Predicate Devices:

| Element of<br>Comparison | Predicate Device-<br>K082554 Kimguard<br>Sterilization wrap | Predicate Device-<br>K143053 Kimguard<br>One-Step Sterilization<br>Wrap | Subject Device-Dukal SMS<br>Sterilization Wrap | Comparison | | until opened. The<br>wrap was validated<br>for aeration times for<br>EtO sterilization of 8<br>hours at 55°C or 12<br>hours at 43.3 °C. The<br>wrap was validated<br>for dry times of 20<br>minutes for Models<br>100, 200, and 300 and<br>for dry times of 30<br>minutes for models<br>400, 500, and 600.<br>KIMGUARD<br>Sterilization Wrap is<br>not indicated for use<br>for gravity steam<br>sterilization. | 55°C and 40-80%<br>relative humidity for<br>60 minutes. The wrap<br>was validated for<br>aeration times for EtO<br>sterilization of 8 hours<br>at 55˚C or 12 hours at<br>43.3°C for Models<br>KC100, and KC200.<br>KIMGUARD One-Step<br>Sterilization Wrap<br>(KC100, KC200) are<br>intended to allow<br>sterilization of the<br>enclosed medical<br>device(s), and also to<br>maintain sterility of<br>the enclosed device(s)<br>until opened.<br>Test results validated<br>that the KIMGUARD<br>One-Step Sterilization<br>Wraps (KC100,KC200)<br>allowed sterilization<br>of the enclosed<br>devices by ethylene<br>oxide sterilization and<br>by pre-vacuum cycles. | The wrap was validated<br>for aeration times for EO<br>sterilization of 16 hours at<br>40.0°C.<br>Dukal SMS sterilization<br>wraps are intended to<br>allow sterilization of the<br>enclosed medical<br>device(s), and also to<br>maintain sterility of the<br>enclosed device(s) until<br>opened. The devices are<br>intended for over-the-<br>counter use and are single<br>use disposable sterilization<br>wraps.<br>Test results validated that<br>the Dukal SMS sterilization<br>wraps allowed sterilization<br>of the enclosed medical<br>device(s) by ethylene<br>oxide sterilization and by<br>pre-vacuum cycles. | |
|--------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------|----------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------|
| Indications<br>for Use | KIMGUARD<br>Sterilization Wrap is<br>intended to be used<br>to enclose another<br>medical device that is<br>to be sterilized by a<br>healthcare provider by<br>pre-vacuum steam at<br>270°F / 132°C for 4<br>minutes or by 100%<br>ethylene oxide (EtO)<br>with a concentration<br>of 725-735 mg/L at<br>131°F / 55°C and 40-<br>80% relative humidity<br>for 60 minutes. The<br>wrap is intended to<br>allow sterilization of<br>the enclosed medical<br>device(s), and also to<br>maintain sterility of<br>the enclosed device(s) | KIMGUARD One-Step<br>Sterilization Wrap<br>(KC100, KC200) are<br>intended to be used<br>to enclose another<br>medical device that is<br>to be sterilized by a<br>healthcare provider<br>using:<br>-Pre-vacuum steam at<br>270°F / 132°C for 4<br>minutes. The wrap<br>was validated for dry<br>times of 20 minutes<br>for Models KC100,<br>and KC200.<br>-100% ethylene oxide<br>(EO) with a<br>concentration of 725-<br>735 mg/L at 131°F / | The Dukal SMS sterilization<br>wraps are intended to be<br>used to enclose another<br>medical device that is to<br>be sterilized by a<br>healthcare provider using:<br>In a steam sterilization<br>pre-vacuum cycle at 270°F<br>/ 132°C for 4 minutes<br>-Models 100, 200 and 300<br>were validated for dry<br>times of 20 minutes;<br>models 400, 500 and 600<br>were validated for dry<br>times of 30 minutes<br>In 100% ethylene oxide<br>(EO) with a concentration<br>of 725-735 mg/L at 131°F/<br>55°C and 40-80% relative<br>humidity for 60 minutes. | Similar | Regulation,<br>Classification<br>, Product<br>Code | Regulation Number:<br>21 CFR 880.6850<br>Classification/Commo<br>n Name: Sterilization<br>Wrap<br>Regulatory Class: II<br>Product Code: FRG | Regulation Number:<br>21 CFR 880.6850<br>Classification/Commo<br>n Name: Sterilization<br>Wrap<br>Regulatory Class: II<br>Product Code: FRG | Regulation Number: 21<br>CFR 880.6850<br>Classification/Common<br>Name: Sterilization Wrap<br>Regulatory Class: II<br>Product Code: FRG | Same |
| Device<br>Design | Two sheets of<br>medium blue<br>nonwoven<br>Polypropylene fabric.<br>Each sheet of fabric<br>is composed of three<br>thermally- bonded<br>layers consisting of a<br>Meltblown | Two sheets of<br>medium blue<br>nonwoven<br>Polypropylene fabric.<br>Each sheet of fabric<br>is composed of three<br>thermally- bonded<br>layers consisting of a<br>Meltblown | Available in one or two<br>sheets of blue nonwoven<br>Polypropylene fabric. Each<br>sheet of fabric is<br>composed of three<br>thermally-bonded layers<br>consisting of a Meltblown<br>polypropylene layer<br>surrounded by Spunbond | Similar | | | | | |

{10}------------------------------------------------

{11}------------------------------------------------

| Method for<br>bonding<br>SMS layers | polypropylene layer<br>surrounded by<br>Spunbond<br>polypropylene layers<br>(SMS). | polypropylene layer<br>surrounded by<br>Spunbond<br>polypropylene layers<br>(SMS). | polypropylene layers<br>(SMS). | Similar |
|-------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------|
| | Thermal bonding with<br>round pin, hexagonal,<br>triangle bond pattern<br>("daisy" pattern) | Thermal bonding with<br>round pin, hexagonal,<br>triangle bond pattern<br>("daisy" pattern) | Thermal bonding with line<br>of one square inch pattern | |
| Materials | Polypropylene with<br>blue and white<br>pigments and<br>antistatic treatment | Polypropylene with<br>blue and white<br>pigments and<br>antistatic treatment | Polypropylene and<br>polyethylene with blue<br>and violet pigments. | Similar |
| Models | 6 basis weights<br>models- Models<br>KC100, KC200, KC300,<br>KC400, KC500 and<br>KC600 | 2 basis weights<br>models- Models<br>KC100 and KC200.<br>KIMGUARD ONE-STEP<br>Sterilization Wrap is<br>comprised of two<br>sheets of KIMGUARD<br>Sterilization Wrap<br>ultrasonically seamed<br>on two edges. This<br>allows for convenient<br>wrapping with<br>two sheets<br>simultaneously. | 6 basis weights models-<br>Models 100, 200, 300, 400,<br>500 and 600<br>Dukal One-Step SMS<br>Sterilization Wrap is<br>comprised of two sheets<br>of Dukal SMS Sterilization<br>Wrap ultrasonically<br>seamed on two edges. This<br>allows for convenient<br>wrapping with two sheets<br>simultaneously. | Similar |
| Product<br>Color and<br>Sizes | Blue and white fabric,<br>9x9", 12x12", 15x15",<br>18x18", 20x20",<br>24x24", 30x30",<br>36x36", 40x40",<br>45x45", 48x48",<br>54x54", 54x72",<br>60x60" | Blue and white fabric,<br>9x9", 12x12", 15x15",<br>18x18", 20x20",<br>24x24", 30x30",<br>36x36", 40x40",<br>45x45", 48x48",<br>54x54", 54x72",<br>60x60" | Blue fabric, 9x9", 12x12",<br>15x15", 18x18", 20x20",<br>24x24", 30x30", 36x36",<br>40x40", 45x45", 48x48",<br>54x54", 54x72", 54x90",<br>60x60" | Similar |
| Prescription<br>vs OTC | OTC | OTC | OTC | Same |
| Single Use<br>vs. Reusable | Single use only | Single use only | Single use only | Same |
| Biocompatibi<br>lity | Applicable parts of ISO<br>10993 ">– Biological<br>evaluation of medical<br>devices | Applicable parts of<br>ISO 10993 – Biological<br>evaluation of medical<br>devices | Applicable parts of ISO<br>10993 – Biological<br>evaluation of medical<br>devices | Same |
| Maintenance<br>of<br>Package<br>Sterility | Real-time testing<br>following sterilization<br>using pre-vacuum<br>steam or Ethylene<br>Oxide supports<br>maintenance of<br>package sterility for<br>30 days. | Real-time testing<br>following sterilization<br>using<br>pre-vacuum steam or<br>Ethylene Oxide<br>supports maintenance<br>of package sterility for<br>365 days. | Accelerated aging testing<br>following sterilization<br>using pre-vacuum steam<br>or Ethylene Oxide supports<br>maintenance of package<br>sterility for 6 months. | Similar |

{12}------------------------------------------------

# Comparison Summary of Non-Clinical Testing Results

| Test | Predicate Device-<br>K082554 Kimguard<br>Sterilization wrap | Predicate Device-<br>K143053 Kimguard<br>One-Step Sterilization<br>Wrap | Subject Device-<br>Dukal SMS<br>Sterilization Wrap | Comparison |
|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------|
| Material<br>Compatibility, ISO<br>11607) &<br>Premarket<br>Notification 510(k)<br>Submissions for<br>Medical Sterilization<br>Packaging Systems in<br>Health Care Facilities;<br>Draft Guidance for<br>Industry and FDA, -<br>- Basis weight,<br>ASTM<br>D3776/D3776M<br>- Air permeability,<br>ASTM D737<br>Compatible<br>- Material burst<br>strength, ASTM<br>D3786<br>- Grab Tensile<br>strength, ASTM<br>D5034<br>- Trapezoidal Tear<br>strength, ASTM<br>D5587 | Compatible | Compatible | Compatible | Same |
| - Hydrosta°c Pressure,<br>AATC127 | | | | |
| Sterilant Penetra on<br>(BI incubation) | BI result: Negative | BI result: Negative | BI result: Negative | Same |
| Maintenance of<br>Package Sterility<br>(ASTM F1608 & USP<br><71>) | No growth<br>Real-time testing<br>following<br>sterilization<br>using pre-vacuum<br>steam or Ethylene<br>Oxide supports<br>maintenance of<br>package sterility for<br>30 days. | No growth<br>Real-time testing<br>following sterilization<br>using<br>pre-vacuum steam or<br>Ethylene Oxide<br>supports maintenance<br>of package sterility for<br>365 days. | No growth<br>Accelerated aging<br>testing following<br>sterilization using<br>pre-vacuum steam<br>or Ethylene Oxide<br>supports<br>maintenance of<br>package sterility<br>for 6 months. | Similar |
| Biocompatibility-<br>Cytotoxicity (ISO 10993-<br>5), Irritation &<br>Sensitization (ISO<br>10993-10) | Under the<br>conditions of the<br>study, the device did<br>not show<br>cytotoxicity<br>potential.<br>Under the<br>conditions of the<br>study, the irritation<br>response category<br>of the device was<br>classified as<br>Negligible.<br>Under the<br>conditions of the<br>study, the device<br>showed no<br>significant evidence<br>of causing delayed<br>dermal contact<br>sensitization. | Under the conditions<br>of the study, the<br>device did not show<br>cytotoxicity potential.<br>Under the conditions<br>of the study, the<br>irritation response<br>category of the device<br>was classified as<br>Negligible.<br>Under the conditions<br>of the study, the<br>device showed no<br>significant evidence of<br>causing delayed<br>dermal contact<br>sensitization. | Under the<br>conditions of the<br>study, the device<br>did not show<br>cytotoxicity<br>potential.<br>Under the<br>conditions of the<br>study, the<br>irritation response<br>category of the<br>device was<br>classified as<br>Negligible.<br>Under the<br>conditions of the<br>study, the device<br>showed no<br>significant<br>evidence of<br>causing delayed<br>dermal contact<br>sensitization. | Same |
| EO Sterilization<br>Residual (ISO 10993-7) | Meet requirements<br>of ISO 10993-7 | Meet requirements of<br>ISO 10993-7 | Meet<br>requirements of<br>ISO 10993-7 | Same |

{13}------------------------------------------------

{14}------------------------------------------------

### Non-Clinical Test Results:

The subject sterilization wraps were tested and found conformance with the following standards:

- ISO 10993-7:2008 Biological Evaluation of Medical Devices-Part 7: Ethylene Oxide Sterilization Residuals
- . ISO 10993-5:2009 Biological Evaluation of Medical Devices-Part 5: Tests for in Vitro Cytotoxicity
- . ISO 10993-10:2021 Biological Evaluation of Medical Devices-Part 10: Tests for Skin Sensitization
- ISO 10993-23: 2021 Biological Evaluation of Medical Devices-Part 23: Tests for Irritation
- ISO 6588-2:2021 Paper, board and pulps—Determination of pH of Aqueous Extracts—Part 2: Hot Extraction
- . ASTM F1980: 2021- Standard Guide for Accelerated Aging of Sterile Barrier Systems and Medical Devices
- ISO 11607-1: 2019 Packaging for Terminally Sterilized Medical Devices Part 1: Requirements for Materials, Sterile Barrier Systems and Packaging Systems
- . AAMI TIR12:2020 Designing, Testing, and Labeling Medical Devices Intended For Processing By Health Care Facilities: A Guide for Device Manufacturers
- . ANSI/AAMI ST79:2017/(R)2022 Comprehensive Guide to Steam Sterilization and Sterility Assurance in Health Care Facilities
- ASTM D3776/D3776M-20 Standard Test Method for Mass Per Unit Area (Weight) of Fabric
- ASTM D1683/D1683M-22 Standard Test Method for Failure in Sewn Seams of Woven Fabrics
- . ASTM D5034-21 Standard Test Method for Breaking Strength and Elongation of Textile Fabrics (Grab Test)
- ASTM D5587-15(2019) Standard Test Method for Tearing Strength of Fabrics by Trapezoid Procedure
- . ASTM D257-14 (Reapproved 2021) Standard Test Methods for DC Resistance or Conductance of Insulating Materials
- . ASTM D3786/D3786M-18 Standard Test Method for Bursting Strength of Textile Fabrics-Diaphragm Bursting Strength Tester Method
- . ISO 9073-10:2003 Textiles-Test methods for nonwovens -Part 10 Lint and other particles generation in the dry state
- 16 CFR Part 1610 Standard for the Flammability of Clothing Textiles
- . AATCC TM193(2017) Test Method for Aqueous Liquid Repellency: Water/Alcohol Solution Resistance
- . ASTM F2101-23 Standard Test Method for Evaluating the Bacterial Filtration Efficiency (BFE) of Medical Face Mask Materials, Using a Biological Aerosol of Staphylococcus aureus
- AATCC Test Method 127-2018 Water Resistance: Hydrostatic Pressure Test
- ASTM D737-18 Standard Test Method for Air Permeability of Textile Fabrics
- ASTM D4966-22 Standard Test Method for Abrasion Resistance of Textile Fabrics (Martindale Abrasion Tester Method)

{15}------------------------------------------------

- . USP-NF 2022 <71> Sterility test
- . ASTM F1608-21 Standard Test Method for Microbial Ranking of Porous Packaging Materials (Exposure Chamber Method)

# Summary for Non-Clinical Testing:

| Test Item | Test<br>Standard<br>Methods | Test Requirements | Test Results of Subject<br>Device-Dukal SMS<br>Sterilization Wrap | Remark |
|------------------------------------------------------------------------|--------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------|
| Basis Weight | ASTM<br>D3776/<br>D3776M-20 | 100: 35gsm(±2gsm)<br>200: 45gsm (±2gsm)<br>300: 52gsm(±2gsm)<br>400: 60gsm(±2gsm)<br>500 70gsm(±2gsm)<br>600:75gsm(±2gsm) | 100: 35gsm(±2gsm)<br>200: 45gsm (±2gsm)<br>300: 52gsm(±2gsm)<br>400: 60gsm(±2gsm)<br>500 70gsm(±2gsm)<br>600:75gsm(±2gsm) | Meets<br>requirement |
| Seam Strength | ASTM<br>D1683/D168<br>3M-22 | ≥20N | ≥20N | Meets<br>requirement |
| Breaking Strength<br>and Elongation | ASTM D5034-<br>21 | Breaking Strength<br>MD≥45N<br>CD≥30N<br>Elongation<br>MD≥20%<br>CD≥20% | Breaking Strength<br>MD≥45N<br>CD≥30N<br>Elongation<br>MD≥20%<br>CD≥20% | Meets<br>requirement |
| Tearing Strength | ASTM D5587-<br>15(2019) | MD≥10N<br>CD≥7N | MD≥10N<br>CD≥7N | Meets<br>requirement |
| Surface Resistance | ASTM D257-<br>14<br>(Reapproved<br>2021) | ≤ 2*10^12 Ω | ≤ 2*10^12 Ω | Meets<br>requirement |
| Bursting Strength | ASTM<br>D3786/D378<br>6M-18 | ≥80 kPa | ≥80 kPa | Meets<br>requirement |
| Lint Generation | ISO 9073-<br>10:2003 | 1.0~4.0<br>(Log 10) | 1.0~4.0<br>(Log 10) | Meets<br>requirement |
| Flammability | 16 CFR Part<br>1610 | Class 1 | Class 1 | Meets<br>requirement |
| Aqueous Liquid<br>Repellency | AATCC<br>TM193(2017) | Grade 3 or above | Grade 3 or above | Meets<br>requirement |
| Bacterial Filtration<br>Efficiency (BFE) | ASTM F2101-<br>23 | ≥50% | ≥50% | Meets<br>requirement |
| Hydrostatic Pressure | AATCC Test<br>Method 127-<br>2018 | ≥20 cmH2O | ≥20 cmH2O | Meets<br>requirement |
| Air Permeability | ASTM D737-<br>18 | ≥20 ft^3/min/ ft^2 | ≥20 ft^3/min/ ft^2 | Meets<br>requirement |
| Abrasion Resistance | ASTM D4966-<br>22 | Grade 3 or above | Grade 3 or above | Meets<br>requirement |
| Sterilant penetra�on-<br>BI incubation | BI incubation | Bl result: Negative | BI result: Negative | Meets<br>requirement |
| Maintenance of<br>Package Sterility-<br>Sterility Test | USP-NF 2022<br><71> | No growth | No growth | Meets<br>requirement |
| Maintenance of<br>Package Sterility-<br>Microbial Aerosol<br>Challenge | ASTM F1608-<br>21 | Average Spore<br>Retained: ≥60% | Average Spore<br>Retained: ≥60% | Meets<br>requirement |
| Biocompatibility-<br>Cytotoxicity, Irritation<br>and Sensitization | ISO 10993-<br>5:2009, ISO<br>10993-23:<br>2021, ISO<br>10993-<br>10:2021 | Under the conditi…