KIMGUARD ONE-STEP STERILIZATION WRAP

K112805 · Kimberly-Clark Corp. · FRG · Jun 22, 2012 · General Hospital

Device Facts

• Record ID: K112805
• Device Name: KIMGUARD ONE-STEP STERILIZATION WRAP
• Applicant: Kimberly-Clark Corp.
• Product Code: FRG · General Hospital
• Decision Date: Jun 22, 2012
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.6850
• Device Class: Class 2

Intended Use

KIMGUARD ONE-STEP* Sterilization Wraps are intended to be used to enclose another medical device that is to be sterilized by a health care provider by prevacuum steam at 270°F/132°C for 4 minutes or by 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. KIMGUARD ONE-STEP* Sterilization Wrap is also intended to be used in the Amsco® V-PRO™ 1 Low Temperature Sterilization System's cycle, the Amsco® V-PRO™ 1 Plus Low Temperature Sterilization System's Lumen (identical to the V-PROTM 1 Cvcle) and Non Lumen Cycles, and the V-PRO™ Low Temperature Sterilization System's Flexible Cycle. The wrap is intended to allow sterilization of the enclosed medical device(s) and also to maintain sterility of the enclosed device(s) until opened within the period of time for which performance data demonstrating maintenance of sterility has been provided. The wrap was validated for aeration times for EO sterilization of 8 hours at 55 °C or 12 hours at 43.3 °C. The KIMGUARD ONE-STEP* Sterilization Wrap was validated for dry times for pre-vacuum steam sterilization of 20 minutes for Models 100 and 200, and for 30 minutes for Models 300, 400, 500, and 600. The KIMGUARD ONE-STEP* Sterilization Wrap was validated to be effectively aerated during the pre-programmed V-PRO™, the V-PRO™ 1 Plus, and the V-PRO™ Flexible Sterilization Cycles. KIMGUARD ONE-STEP* Sterilization Wrap is not indicated for use for gravity steam sterilization.

Device Story

KIMGUARD ONE-STEP* Sterilization Wrap consists of two ultrasonically seamed sheets of polypropylene SMS (spunbond-meltblown-spunbond) fabric. Used by healthcare providers to wrap medical instruments prior to sterilization. Device acts as a barrier to maintain sterility of contents post-sterilization. Validated for specific sterilization cycles (pre-vacuum steam, EO, and V-PRO low-temperature systems) and specific dry/aeration times. Performance varies by model (KC100-KC600) based on load weight and type. Benefits include convenient wrapping and validated sterility maintenance periods (up to 1 year for certain models/cycles).

Clinical Evidence

Bench testing only. Sterility maintenance validated through studies measuring maintenance of sterility for pack contents post-sterilization. Validated for pre-vacuum steam, EO, and V-PRO low-temperature cycles. Sterilant penetration, dry time, and physical integrity validated per previously cleared submissions.

Technological Characteristics

Two-sheet polypropylene SMS (spunbond-meltblown-spunbond) fabric; ultrasonically seamed. Models KC100-KC600 vary by weight capacity and validated sterility maintenance duration. Passive barrier technology; no energy source or software.

Indications for Use

Indicated for use by healthcare providers to enclose medical devices for sterilization via pre-vacuum steam, 100% ethylene oxide, or specific Amsco V-PRO low-temperature sterilization systems. Maintains sterility of enclosed devices until opened. Not indicated for gravity steam sterilization.

Regulatory Classification

Identification

A sterilization wrap (pack, sterilization wrapper, bag, or accessories, is a device intended to be used to enclose another medical device that is to be sterilized by a health care provider. It is intended to allow sterilization of the enclosed medical device and also to maintain sterility of the enclosed device until used.

Predicate Devices

• Kimberly-Clark KIMGUARD* ONE-STEP* Sterilization Wrap (K082177)
• Kimberly-Clark KIMGUARD* ONE-STEP* Sterilization Wrap (K091685)
• Kimberly-Clark KIMGUARD* ONE-STEP* Sterilization Wrap (K092167)

Reference Devices

• V-PRO 1 Plus Low Temperature Sterilization System (K102330)

Submission Summary (Full Text)

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# JUN 2 2 2 2012

# KII2805

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## 510(k) Summary for the Kimberly-Clark* Corporation KIMGUARD ONE-STEP* Sterilization Wrap (Models KC100 – KC600)

| Date of Submission: | September 9, 2011 |
|---------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device type: | Sterilization Wrap |
| 510(k) Submitter: | Brenda Shelkey<br>Associate Director, Quality Assurance & Regulatory<br>Affairs<br>KIMBERLY-CLARK CORPORATION<br>1400 Holcomb Bridge Road<br>Roswell, GA 30076<br>678-654-8021<br>[e-mail]<br>Establishment Registration Number 1033422 |
| Primary Contact<br>for this 510(k)<br>Submission: | Brenda Shelkey<br>Associate Director, Quality Assurance & Regulatory<br>Affairs<br>KIMBERLY-CLARK CORPORATION<br>1400 Holcomb Bridge Road<br>Roswell, GA 30076<br>678-654-8021<br>[e-mail] |
| Confidentiality<br>Request: | Pursuant to 21 CFR 807.95, please treat with<br>confidentiality the additional information presented in<br>this notification and Kimberly-Clark's intent to market the<br>medical devices described herein with changes. |
| Classification<br>Regulation: | 21 CFR 880.6850 |
| Device Class: | Class II |
| Panel: | General Hospital |
| Product Code: | FRG |

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#### Intended Use:

KIMGUARD ONE-STEP* Sterilization Wraps are intended to be used to enclose another medical device that is to be sterilized by a health care provider by prevacuum steam at 270°F/132°C for 4 minutes or by 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. KIMGUARD ONE-STEP* Sterilization Wrap is also intended to be used in the Amsco® V-PRO™ 1 Low Temperature Sterilization System's cycle, the Amsco® V-PRO™ 1 Plus Low Temperature Sterilization System's Lumen (identical to the V-PROTM 1 Cvcle) and Non Lumen Cycles, and the V-PRO™ Low Temperature Sterilization System's Flexible Cycle. The wrap is intended to allow sterilization of the enclosed medical device(s) and also to maintain sterility of the enclosed device(s) until opened within the period of time for which performance data demonstrating maintenance of sterility has been provided. The wrap was validated for aeration times for EO sterilization of 8 hours at 55 °C or 12 hours at 43.3 °C. The KIMGUARD ONE-STEP* Sterilization Wrap was validated for dry times for pre-vacuum steam sterilization of 20 minutes for Models 100 and 200, and for 30 minutes for Models 300, 400, 500, and 600. The KIMGUARD ONE-STEP* Sterilization Wrap was validated to be effectively aerated during the pre-programmed V-PRO™, the V-PRO™ 1 Plus, and the V-PRO™ Flexible Sterilization Cycles.

KIMGUARD ONE-STEP* Sterilization Wrap is not indicated for use for gravity steam sterilization.

Device Description: KIMGUARD ONE-STEP* Sterilization Wrap is comprised of two sheets of KIMGUARD* Sterilization Wrap ultrasonically seamed on two sides. This allows for convenient wrapping with two sheets simultaneously. The sheets of sterilization wrap are square or rectanqular fabric produced usinq a polypropylene three-layer SMS (spunbond-meltblown-spunbond) process.

Substantial Equivalence: KIMGUARD ONE-STEP* Sterilization Wrap is substantially equivalent to the predicate Kimberly-Clark KIMGUARD* ONE-STEP* Sterilization Wrap (K082177,K091685, and K092167) in intended use, design, and materials.

Summary of Testing: KIMGUARD ONE-STEP* Sterilization Wrap was previously tested in compliance with the irritation and sensitization biocompatibility methods of ISO 10993 and cleared under K082177 and K091685. Sterilant penetration, dry time, and physical integrity were validated and cleared under K082177, K091685 and K092167. The wrap, Models KC300, KC400, KC500, and KC600, has been tested and shown to maintain sterility of pack contents after sterilization for at least one (1) year under standard conditions following pre-vacuum steam and ethylene oxide sterilization cycles. The wrap, Models KC100 and KC200, has been tested and shown to maintain

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sterility of pack contents after sterllization for at least 30 days under standard conditions following pre-vacuum steam and ethylene oxide sterilization. The wrap, Models KC100, KC200, KC300, KC400, KC500, and KC600, has been tested and shown to maintain sterility of pack contents after sterllization for at least 30 days under standard conditions following sterilization with the Amsco V-PRO 1 and V-PRO 1 Plus and Flexible Cycle Low Temperature Sterilization Systems. Additionally, the wrap, Models KC100 through KC600, has been tested for use in the V-PRO 16 Low Temperature Sterilization System's Flexible Cycle being considered under K102330 filed by STERIS Corporation.

| Table 1. Wrap Model Recommendations for Pre-Vacuum Steam and Ethylene |
|-----------------------------------------------------------------------|
| Oxide Sterilization Cycles1 |

| KIMGUARD<br>ONE-STEP*<br>Sterilization<br>Wrap Models | Intended Loads | Maximum<br>Wrapped<br>Package<br>Content<br>Weights Used in<br>Sterility<br>Maintenance<br>Validation<br>Study2 | Descriptions of Loads Used in Sterility<br>Maintenance Validation Study2 |
|-------------------------------------------------------|------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| KC100 | Very Light Weight<br>Package (for<br>example: towel<br>packs) | 3 lbs | 16 huck towels (17"x 29") |
| KC200 | Light Weight Package<br>(for example:<br>standard linen packs) | 6 lbs | 2 huck towels (17"x 29")<br>2 fluid resistant U-drape (68"x109")<br>1 fluid resistant universal bar drape<br>(70" x 108") |
| KC300 | Light to Moderate<br>Weight Package (for<br>example: general use<br>medical instruments) | 9 lbs | For Pre-Vacuum Steam:<br>15 huck towels (17"x 29")<br>1 small fluid resistant drape (60"x 76")<br>5 lbs of metal mass<br>For EO:<br>16 huck towels<br>2 fluid resistant large drapes (76"x100")<br>1 fluid resistant small drape (76"x60")<br>1 fluid resistant table cover (60"x 90") |
| KC4003 | Moderate to Heavy<br>Weight Package (for<br>example: general use<br>medical instruments) | 13 lbs | 4 tray liners 20" x 25" stacked<br>10" x 10" x 3 ½ " tray containing 11 lbs of<br>metal mass |
| KC5003 | Heavyweight<br>Package (for<br>example: general use<br>medical instruments) | 17 lbs | 4 tray liners 20" x 25" stacked<br>10" x 10" x 3 ½ " tray containing<br>15 lbs of metal mass |
| KC6003 | Very Heavy Weight<br>Package (for<br>example: general<br>use medical<br>instruments) | 25 lbs | 4 tray liners 20" x 25" stacked<br>10" x 10" x 3 ½ " tray containing<br>23 lbs of metal mass |

Individual results may differ due to factors such as variations in handling practices, wrapping techniques, and folding mornodal router 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. 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

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validated for the KIMGUARD ONE-STEP* Sterilization Wraps (i.e.: the number and size of the fluid resistant linens or the weight of the metal mass).

"The KC400, KC500 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 KC600 model wraps, as use of such fluid resistant materials has not been evaluated with these models.

Table 2. Wrap Model Recommendations for Amsco V-PRO™ 1. V-PRO 1 Plus and Flexible Cycle1 Low Temperature Sterilization System

| KIMGUARD<br>ONE-STEP*<br>Sterilization<br>Wrap Models | Intended Loads | Maximum<br>Wrapped<br>Package<br>Content<br>Weights Used<br>in Sterility<br>Maintenance<br>Validation<br>Study2 | Descriptions of Loads Used in<br>Sterility Maintenance Validation<br>Study2 |
|-------------------------------------------------------|------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------|
| KC100 | Very Light Weight<br>Package (for<br>example batteries) | 3 lbs | 3 lbs metal mass 6 forceps |
| KC200 | Light Weight<br>Package (for<br>example telescope<br>with light cord) | 6.5 lbs | 2.5 lbs metal mass 6 forceps V-PRO tray (17" x 10" x 3½") at 4 lbs |
| KC300 | Light to Moderate<br>Weight Package<br>(for example:<br>general use<br>medical<br>instruments) | 9 lbs | 5 lbs metal mass 6 forceps V-PRO tray (17" x 10" x 3½") at 4 lbs |
| KC400 | Moderate to Heavy<br>Weight Package<br>(for example:<br>general use<br>medical<br>instruments) | 10 lbs | 6 lbs metal mass 6 forceps V-PRO tray (17" x 10" x 3½") at 4 lbs |
| KC500 | Heavyweight<br>Package (for<br>example: general<br>use medical<br>instruments) | 10 lbs | 5 lbs metal mass 6 forceps V-PRO tray (21" x 10" x 3½") at 5 lbs |
| KC600 | Very Heavy Weight<br>Package (for<br>example: general<br>use medical<br>instruments) | 10 lbs | 5 lbs metal mass 6 forceps V-PRO tray (21" x 10" x 3½") at 5 lbs |

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 grade 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 KIMGUARD ONE-STEP Sterilization Wraps (i.e.: the weight of the metal mass).

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| Models | Pre-Vacuum Steam<br>Sterilization | EO Sterilization | V-PRO Cycles |
|----------------------------------------------------------------------------------------|-----------------------------------|------------------|------------------|
| KIMGUARD One-Step*<br>Sterilization Wrap<br>Models KC100 and<br>KC200 | At least 30 days | At least 30 days | At least 30 days |
| KIMGUARD One-Step*<br>Sterilization Wrap<br>Models KC300,<br>KC400, KC500 and<br>KC600 | At least 1 year | At least 1 year | At least 30 days |

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Table 3: Maintenance of Package Sterility Recommendations

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Image /page/5/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo features a stylized caduceus symbol, which is a staff with two snakes coiled around it. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the caduceus symbol.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room-WO66-G609 Silver Spring, MD 20993-0002

Ms. Brenda Shelkey Associate Director, Quality Assurance & Regulatory Kimberly-Clark Corporation 1400 Holcomb Bridge Road Building 300 Roswell, Georgia 30076

JUN 2 2 2012

Re: K112805

Trade/Device Name: KIMGUARD ONE- STEP* Sterilization Wrap (Models KC100, KC200, KC300, KC400, KC500, and KC600) Regulation Number: 21 CFR 880.6850 Regulation Name: Sterilization Wrap Regulatory Class: II Product Code: FRG Dated: June 14, 2012 Received: June 14, 2012

Dear Ms. Shelkey:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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### Page 2- Ms. Shelkey

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 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to

http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Th for

Anthony D. Watson, B.S., M.S., M.B.A. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

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#### Indications for Use

#### 510(k) Number: K112805

#### KIMGUARD ONE-STEP* Sterilization Wrap (Models KC100, KC200, Device Name: KC300, KC400, KC500, and KC600)

#### Indications for Use:

KIMGUARD ONE-STEP* Sterilization Wraps are intended to be used to enclose another medical device that is to be sterilized by a health care provider by pre-vacuum steam at 270°F/132°C for 4 minutes or by 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. KIMGUARD ONE-STEP* Sterilization Wrap is also intended to be used in the Amsco® V-PRO™ 1 Low Temperature Sterilization System's cycle, the Amsco® V-PRO™ 1 Plus Low Temperature Sterilization System's Lumen (identical to the V-PRO™ 1 Cycle) and Non Lumen Cycles, and the V-PRO™ Low Temperature Sterilization System's Flexible Cycle. The wrap is intended to allow sterilization of the enclosed medical device(s) and also to maintain sterility of the enclosed device(s) until opened within the period of time for which performance data demonstrating maintenance of sterility has been provided. The wrap was validated for aeration times for EO sterilization of 8 hours at 55 ℃ or 12 hours at 43.3 °C. The KIMGUARD ONE-STEP* Sterilization Wrap were validated for dry times for pre-vacuum steam sterilization of 20 minutes for Models 100 and 200, and for 30 minutes for Models 300, 400, 500, and 600. The KIMGUARD ONE-STEP* Sterilization Wrap was validated to be effectively aerated during the pre-programmed V-PRO™, V-PROTM 1 Plus, and the V-PROTM Flexible Sterilization Cycles.

KIMGUARD ONE-STEP* Sterilization Wraps are not indicated for use for gravity steam sterilization.

Prescription Use (Part 21 CFR 801 Subpart D) AND/OR

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

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Elizth F. Chamire-Willer

ion of Anesthesionaly, Goneral Hos

K112895 KIMGUARD ONE-STEP* Sterilization Wrap

510(k) Numbe

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Table 1. Wrap Model Recommendations for Pre-Vacuum Steam and Ethylene Oxide Sterilization Cvcles1

| KIMGUARD<br>ONE-STEP*<br>Sterilization<br>Wrap Models | Intended Loads | Maximum<br>Wrapped<br>Package<br>Content<br>Weights Used in<br>Sterility<br>Maintenance<br>Validation<br>Study2 | Descriptions of Loads Used in Sterility<br>Maintenance Validation Study2 |
|-------------------------------------------------------|------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| KC100 | Very Light Weight<br>Package (for<br>example: towel<br>packs) | 3 lbs | 16 huck towels (17"x 29") |
| KC200 | Light Weight Package<br>(for example:<br>standard linen packs) | 6 lbs | 2 huck towels (17"x 29")<br>2 fluid resistant U-drape (68"x109")<br>1 fluid resistant universal bar drape<br>(70" x 108") |
| KC300 | Light to Moderate<br>Weight Package (for<br>example: general use<br>medical instruments) | 9 lbs | For Pre-Vacuum Steam:<br>15 huck towels (17"x 29")<br>1 small fluid resistant drape (60"x 76")<br>5 lbs of metal mass<br>For EO:<br>16 huck towels<br>2 fluid resistant large drapes (76"x100")<br>1 fluid resistant small drape (76"x60")<br>1 fluid resistant table cover (60"x 90") |
| KC4003 | Moderate to Heavy<br>Weight Package (for<br>example: general use<br>medical.instruments) | 13 lbs | 4 tray liners 20" x 25" stacked<br>10" x 10" x 3 ½ " tray containing 11 lbs of<br>metal mass |
| KC5003 | Heavyweight<br>Package (for<br>example: general use<br>medical instruments) | 17 lbs | 4 tray liners 20" x 25" stacked<br>10" x 10" x 3 ½ " tray containing<br>15 lbs of metal mass |
| KC6003 | Very Heavy Weight<br>Package (for<br>example: general<br>use medical<br>instruments) | 25 lbs | 4 tray liners 20" x 25" stacked<br>10" x 10" x 3 ½ " tray containing<br>23 lbs of metal mass |

' Individual results may differ due to factors such as variations in handling practices, wroping techniques, and folding methods. Results may also differ due to the use of irregularly shaped contents, which may put added stress on the menous. They also they also olifer doo to the asso of itself which wrap model is most appropriate for each intended use.

with is recommended to not exceed the maximum wrapped package content weights indicated for each ware model. it is roommondou to not exceed the number, weight, and size of individual content types that were Futuremore, it is recommended to not bloods the hands, we and size of the fluid resistant linens or the weight of the metal mass).

welglif of the metal mass;
3 The KC400, KC500, and KC600 model wraps were validated for sterilant penetration with has models The KC400, RC300, and RO00 model Maps were validation of sterilization ordels will these models. It is
linen, and it is recommended to not exceed 3 lbs of non-fluid research iment, and its recommended to the exceed i bother hand in KC400, KC500, and KC600 model wraps, as use of such fluid resistant materials has not been evaluated with these models.

# K112895 KIMGUARD ONE-STEP* Sterilization Wrap

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| Table 2. Wrap Model Recommendations for Amsco V-PRO'™ 1, V-PRO 1 | |
|-------------------------------------------------------------------|--|
| Plus and Flexible Cvcle' Low Temperature Sterilization System | |

| KIMGUARD<br>ONE-STEP*<br>Sterilization<br>Wrap Models | Intended Loads | Maximum<br>Wrapped<br>Package.<br>Content<br>Weights Used<br>in Sterility<br>Maintenance<br>Validation<br>Study2 | Descriptions of Loads Used in<br>Sterility Maintenance Validation<br>Study2 |
|-------------------------------------------------------|------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------|
| KC100 | Very Light Weight<br>Package (for<br>example batteries) | 3 lbs | 3 lbs metal mass 6 forceps |
| KC200 | Light Weight<br>Package (for<br>example telescope<br>with light cord) | 6.5 lbs | 2.5 lbs metal mass 6 forceps V-PRO tray (17" x 10" x 3½") at 4 lbs |
| KC300 | Light to Moderate<br>Weight Package<br>(for example:<br>general use<br>medical<br>instruments) | 9 lbs | 5 lbs metal mass 6 forceps V-PRO tray (17" x 10" x 3½") at 4 lbs |
| KC400 | Moderate to Heavy<br>Weight Package<br>(for example:<br>general use<br>medical<br>instruments) | 10 lbs | 6 lbs metal mass 6 forceps V-PRO tray (17" x 10" x 3½") at 4 lbs |
| KC500 | Heavyweight<br>Package (for<br>example: general<br>use medical<br>instruments) | 10 lbs | 5 lbs metal mass 6 forceps V-PRO tray (21" x 10" x 3½") at 5 lbs |
| KC600 | Very Heavy Weight<br>Package (for<br>example: general<br>use medical<br>instruments) | 10 lbs | 5 lbs metal mass 6 forceps V-PRO tray (21" x 10" x 3½") at 5 lbs |

Individual results may differ due to factors such as variations in handling practices, wrapping techniques, and folling methods. Results may also differ due to the use of irregularly shaped contents, which may put added stress on the wrap. methous: Tresults may also differ doo or mogulary of the spropriate for each intended use.
Each healthcare facility should determine for itself which wrappropriate for each w ² It is recommended to not exceed the maximum wapped 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 r dithornere, it is 1000mmbhidou to not Sterliization Wraps (i.e.: the weight of the metal mass).

# K112895 KIMGUARD ONE-STEP* Sterilization Wrap

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| Models | Pre-Vacuum Steam<br>Sterilization | EO Sterilization | V-PRO Cycles |
|----------------------------------------------------------------------------------------|-----------------------------------|------------------|------------------|
| KIMGUARD One-Step*<br>Sterilization Wrap<br>Models KC100 and<br>KC200 | At least 30 days | At least 30 days | At least 30 days |
| KIMGUARD One-Step*<br>Sterilization Wrap<br>Models KC300,<br>KC400, KC500 and<br>KC600 | At least 1 year | At least 1 year | At least 30 days |

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### Table 3: Maintenance of Package Sterility Recommendations

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# K112895 KIMGUARD ONE-STEP* Sterilization Wrap

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