Predicate Devices

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The device description and performance studies focus on the physical barrier properties of the gown, with no mention of AI or ML.

Therapeutic

No

The device is a gown intended to protect healthcare personnel from exposure to chemotherapy drugs, not to treat a medical condition or therapeutic effect on a patient.

Diagnostic

No

The device is a protective gown designed to prevent exposure to chemotherapy drugs, not to diagnose medical conditions.

SaMD (Software as a Medical Device)

No

The device description clearly states it is a physical gown made of laminate with adhesive taped seams, hook and loop closures, waist ties, and knit cuffs. It is a tangible, physical medical device, not software.

IVD (In Vitro Diagnostic)

Based on the provided text, this device is not an IVD (In Vitro Diagnostic).

Here's why:

Intended Use: The intended use is to "protect healthcare personnel from exposure to chemotherapy drugs during preparation, handling, and administration." This is a protective function for the user, not a diagnostic test performed on a sample from a patient.
Device Description: The device is described as a "Surgical Gown" and is classified under "General & Plastic Surgery Panel." This classification is for devices used in surgical or protective settings, not for in vitro diagnostic testing.
Lack of Diagnostic Elements: There is no mention of analyzing biological samples, detecting markers, or providing diagnostic information about a patient's health status.
Performance Studies: The performance studies focus on barrier properties, chemical permeation resistance, and material characteristics, which are relevant to protective wear, not diagnostic accuracy.

IVD devices are specifically designed to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. This device does not fit that description.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

The Cardinal Health™ ChemoPlus™ Full Coverage Gowns, Closed Back, are intended to protect healthcare personnel from exposure to chemotherapy drugs during preparation, handling, and administration.

The closed back gowns are single use, disposable medical devices provided sterile. The non-sterile, closed back gowns are not intended for use in the operating room.

The Cardinal Health™ ChemoPlus™ Full Coverage Gowns, Open Back, are intended to protect healthcare personnel from exposure to chemotherapy drugs during preparation, handling, and administration.

The open back gowns are single use, disposable medical devices provided non-sterile. The open-back gown is nonprotective in the back. The open-back gowns are not intended for use in the operating room.

Product codes (comma separated list FDA assigned to the subject device)

FYA

Device Description

The Cardinal Health™ ChemoPlus™ Full Coverage Closed Back and Open Back Gowns are classified as Class II medical devices under Regulation 21 CFR 878.4040, General & Plastic Surgery Panel, FDA product code FYA, Surgical Gown.

The ChemoPlus™ Full Coverage Closed Back and Open Back Gowns are made of a laminate with adhesive taped seams. Both closed and open back gowns have a hook and loop closure at the back of the neck and a waist tie feature to secure the gown to the body of the user. The sleeves of the gown have knit cuffs sewn onto the end of the sleeve at the user's wrists to keep the sleeves in place on the wearer. The entire gown including the gown sleeves are made of the same material and utilize the same manufacturing processes.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Not Found

Indicated Patient Age Range

Not Found

Intended User / Care Setting

healthcare personnel

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

Non-Clinical Performance Testing was conducted.
The proposed gowns meet the barrier protection requirements of AAMI Level 3 per ANSI/AAMI Standard PB70:2012 Liquid Barrier Performance and Classification of Protective Apparel and Drapes intended for use in Health Care Facilities.
The gowns have been evaluated for resistance to permeation of various chemotherapy drugs per ASTM F739-12, Standard Test Method for Permeation of Liquids and Gases Through Protective Clothing Materials Under Conditions of Continuous Contact.
Chemotherapy drug permeation resistance, average standardized breakthrough time in minutes *:
Carmustine [3.3 mg/ml] >480
Cisplatin [1.0 mg/ml] >480
Cyclophosphamide [20 mg/ml] >480
Cytarabine Hydrochloride [100 mg/ml] >480
Dacarbazine [10 mg/ml] >480
Daunorubicin Hydrochloride [5 mg/ml] >480
Doxorubicin Hydrochloride [2 mg/ml] >480
Etopside [20 mg/ml] >480
Fluorouracil [50 mg/ml] >480
Ifosfamide [50 mg/ml] >480
Methotrexate [25 mg/ml] >480
Mitomycin C [0.5 mg/ml] >480
Mitoxantrone [2.0 mg/ml] >480
Paclitaxel [6 mg/ml] >480
Thiotepa [10 mg/ml] >480
Vincristine Sulfate [1 mg/ml] >480
*No permeation was detected at either the minimum detectable permeation or 0.1 µg/cm²/min

Testing was conducted to establish that the proposed devices meet acceptance criteria for its intended use and demonstrate that each device is as safe and as effective as the predicate device.
Summary of Non-Clinical Performance Testing:
AATCC 42 - Spray Impact - Water Resistance - PASS
AATCC 127 - Hydrostatic Pressure - Water Resistance - PASS
ANSI/AAMI PB70:2012 AAMI Level 3 - Liquid Barrier Performance - Water Resistance - PASS
ASTM F739-12 - Permeation of Liquids and Gasses through Protective Clothing - Chemical Permeation Under Continuous Contact - PASS
ASTM D3776/D3776M-17 - Weight of Woven Fabric - Material Weight - PASS
ASTM D5034 - 9 2017 - Grab Tensile, Peak Stretch, and Peak Energy – Nonwovens - Tensile Strength - PASS
ASTM 1683-17 (2018) - Standard Test Method for Failure in Sewn Seams of Woven Apparel Fabrics - Seam Strength - PASS
ASTM D5587-15 (2019) - Standard Test Method for Tearing Strength of Fabrics by the Trapezoid Procedure - Trapezoid Tear - PASS
NWSP 160.1 - Resistance to Linting of Nonwoven Fabrics (Dry) - Particulate - PASS
16 CFR 1610 - Standard for the Flammability for Clothing Textiles - Flammability - PASS
ISO 10993-5:2009 - ISO MEM Elution Cytotoxicity - Cytotoxicity - PASS
ISO 10993 10:2010 - ISO Indirect Primary Skin Irritation Test - Irritation - PASS
ISO 10993-10:2010 - Guinea Pig Maximization Test - Sensitization - PASS
ISO 10993-7:2008 (R) 2012 - EO Sterilization Residuals (Sterile Catalog Numbers) - EO and ECH Residuals - PASS

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K052824

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

Regulation Number and Section

§ 878.4040 Surgical apparel.

(a)
Identification. Surgical apparel are devices that are intended to be worn by operating room personnel during surgical procedures to protect both the surgical patient and the operating room personnel from transfer of microorganisms, body fluids, and particulate material. Examples include surgical caps, hoods, masks, gowns, operating room shoes and shoe covers, and isolation masks and gowns. Surgical suits and dresses, commonly known as scrub suits, are excluded.(b)
Classification. (1) Class II (special controls) for surgical gowns and surgical masks. A surgical N95 respirator or N95 filtering facepiece respirator is not exempt if it is intended to prevent specific diseases or infections, or it is labeled or otherwise represented as filtering surgical smoke or plumes, filtering specific amounts of viruses or bacteria, reducing the amount of and/or killing viruses, bacteria, or fungi, or affecting allergenicity, or it contains coating technologies unrelated to filtration (e.g., to reduce and or kill microorganisms). Surgical N95 respirators and N95 filtering facepiece respirators are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 878.9, and the following conditions for exemption:(i) The user contacting components of the device must be demonstrated to be biocompatible.
(ii) Analysis and nonclinical testing must:
(A) Characterize flammability and be demonstrated to be appropriate for the intended environment of use; and
(B) Demonstrate the ability of the device to resist penetration by fluids, such as blood and body fluids, at a velocity consistent with the intended use of the device.
(iii) NIOSH approved under its regulation.
(2) Class I (general controls) for surgical apparel other than surgical gowns and surgical masks. The class I device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 878.9.

Summary

0

Image /page/0/Picture/0 description: The image shows 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, with the letters "FDA" in a blue square. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

March 20, 2020

Cardinal Health 200, LLC Caroline Miceli Regulatory Affairs Manager 3651 Birchwood Drive Waukegan, Illinois 60085

Re: K193327

Trade/Device Name: Cardinal Health ChemoPlus Full Coverage Gown, Closed Back, Cardinal Health ChemoPlus Full Coverage Gown, Open Back Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical Apparel Regulatory Class: Class II Product Code: FYA Dated: January 28, 2020 Received: January 29, 2020

Dear Caroline Miceli:

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. 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 located 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.

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

1

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 803) for devices or postmarketing safety reporting (21 CFR 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 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 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 medical devices and radiation-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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Elizabeth F. Claverie, MS Assistant Director DHT4B: Division of Infection Control and Plastic Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

2

Indications for Use

510(k) Number (if known) K193327

Device Name

Cardinal Health™ ChemoPlus™ Full Coverage Gown, Closed Back Cardinal Health™ ChemoPlus™ Full Coverage Gown, Open Back

Indications for Use (Describe)

Cardinal Health™ ChemoPlus™ Full Coverage Gown, Closed Back

The Cardinal Health™ ChemoPlus™ Full Coverage Gowns, Closed Back, are intended to protect healthcare personnel from exposure to chemotherapy drugs during preparation, handling, and administration.

The closed back gowns are single use, disposable medical devices provided sterile. The non-sterile, closed back gowns are not intended for use in the operating room.

| Catalog

Number	Product Description	Size	Sterility
CT5502T	Cardinal Health™ ChemoPlus™ Full Coverage Gown Closed Back	M	Non-sterile
CT5503T	Cardinal Health™ ChemoPlus™ Full Coverage Gown Closed Back	L	Non-sterile
CT5504T	Cardinal Health™ ChemoPlus™ Full Coverage Gown Closed Back	XL	Non-sterile
CT5505T	Cardinal Health™ ChemoPlus™ Full Coverage Gown Closed Back	XXL	Non-sterile
CT5502TS	Cardinal Health™ ChemoPlus™ Full Coverage Gown Closed Back	M	Sterile
CT5503TS	Cardinal Health™ ChemoPlus™ Full Coverage Gown Closed Back	L	Sterile
CT5504TS	Cardinal Health™ ChemoPlus™ Full Coverage Gown Closed Back	XL	Sterile
CT5505TS	Cardinal Health™ ChemoPlus™ Full Coverage Gown Closed Back	XXL	Sterile

ChemoPlus™ Gowns Catalog Number Summary

The proposed gowns meet the barrer protection requirements of AAMI Level 3 per ANSI/AAMI Standard PB70:2012 Liquid Barrier Performance and Classification of Protective Apparel and Drapes intended for use in Health Care Facilities.

The gowns have been evaluated for resistance to permeation of various chemotherapy drugs per ASTM F739-12, Standard Test Method for Permeation of Liquids and Gases Through Protective Clothing Materials Under Conditions of Continuous Contact. Chemotherapy drug permeation resistance, average standardized breakthrough time in minutes *:

Carmustine [3.3 mg/ml] >480 Cisplatin [1.0 mg/ml] >480 Cyclophosphamide [20 mg/ml] >480 Cytarabine Hydrochloride [100 mg/ml] >480 Dacarbazine [10 mg/ml] >480 Daunorubicin Hydrochloride [5 mg/ml] >480 Doxorubicin Hydrochloride [2 mg/ml] > 480 Etopside [20 mg/ml] >480 Fluorouracil [50 mg/ml] >480 lfosfamide [50 mg/ml] > 480 Methotrexate [25 mg/ml] >480 Mitomycin C [0.5 mg/ml] >480 Mitoxantrone [2.0 mg/ml] >480

3

Paclitaxel [6 mg/ml] >480 Thiotepa [10 mg/ml] >480 Vincristine Sulfate [1 mg/ml] >480

*No permeation was detected at either the minimum detectable permeation or 0.1 µg/cm²/min

When chemotherapy drugs are present, gown selection should be based on the specific type(s) of chemicals used. Users are recommended to review drug labeling or material safety data sheets for the chemicals being used to determine an adequate level of protection.

Cardinal Health™ ChemoPlus™ Full Coverage Gown, Open Back

The Cardinal Health™ ChemoPlus™ Full Coverage Gowns, Open Back, are intended to protect healthcare personnel from exposure to chemotherapy drugs during preparation, handling, and administration.

The open back gowns are single use, disposable medical devices provided non-sterile. The open-back gown is nonprotective in the back. The open-back gowns are not intended for use in the operating room.

| Catalog

Number	Product Description	Size	Sterility
DP5003GT	Cardinal Health™ ChemoPlus™ Full Coverage Gown Open Back	M	Non-Sterile
DP5001GT	Cardinal Health™ ChemoPlus™ Full Coverage Gown Open Back	L	Non-Sterile
DP5002GT	Cardinal Health™ ChemoPlus™ Full Coverage Gown Open Back	XL	Non-Sterile
DP5004GT	Cardinal Health™ ChemoPlus™ Full Coverage Gown Open Back	XXL	Non-Sterile

ChemoPlus™ Gowns Catalog Number Summary

The proposed gowns meet the barrier protection requirements of AAMI Level 3 per ANSI/AAMI Standard PB70:2012 Liquid Barrier Performance and Classification of Protective Apparel and Drapes intended for use in Health Care Facilities.

The gowns have been evaluated for resistance to permeation of various chemotherapy drugs per ASTM F739-12, Standard Test Method for Permeation of Liquids and Gases Through Protective Clothing Materials Under Conditions of Continuous Contact. Chemotherapy drug permeation resistance, average standardized breakthrough time in minutes *:

Carmustine [3.3 mg/ml] >480 Cisplatin [1.0 mg/ml] >480 Cyclophosphamide [20 mg/ml] >480 Cytarabine Hydrochloride [100 mg/ml] >480 Dacarbazine [10 mg/ml] >480 Daunorubicin Hydrochloride [5 mg/ml] >480 Doxorubicin Hydrochloride [2 mg/ml] > 480 Etopside [20 mg/ml] >480 Fluorouracil [50 mg/ml] >480 lfosfamide [50 mg/ml] > 480 Methotrexate [25 mg/ml] >480 Mitomycin C [0.5 mg/ml] >480 Mitoxantrone [2.0 mg/ml] >480

Page 2 of 3 FORM FDA 3881 (7/17)

4

Paclitaxel [6 mg/ml] >480 Thiotepa [10 mg/ml] >480 Vincristine Sulfate [1 mg/ml] >480

*No permeation was detected at either the minimum detectable permeation or 0.1 µg/cm²/min

When chemotherapy drugs are present, gown selection should be based on the specific type(s) of chemicals used. Users are recommended to review drug labeling or material safety data sheets for the chemicals being used to determine an adequate level of protection.

Type of Use (Select one or both, as applicable) Prescription Use (Part 21 CFR 801 Subpart D)

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

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5

Image /page/5/Picture/0 description: The image shows the logo and address of Cardinal Health. The logo consists of the company name in bold black letters with a red graphic above it. The address is listed as 3651 Birchwood Drive, Waukegan, IL 60085, and the website is www.cardinalhealth.com in red.

510(k) SUMMARY K193327

Cardinal Health™ ChemoPlus™ Full Coverage Gown, Closed Back Cardinal Health™ ChemoPlus™ Full Coverage Gown, Open Back

| Manufacturer: | Cardinal Health 200, LLC
3651 Birchwood Drive
Waukegan, IL 60085 |
|-----------------------------|--------------------------------------------------------------------------------------------------------------------------------|
| Regulatory Affairs Contact: | Caroline Miceli
3651 Birchwood Drive
Waukegan, IL 60085 |
| Telephone Number: | (312) 270-2013 |
| Fax Number: | 847-473-2114 |
| Date Summary Prepared: | March 18, 2020 |
| Trade Name: | Cardinal Health™ ChemoPlus™ Full Coverage Gown, Closed
Back
Cardinal Health™ ChemoPlus™ Full Coverage Gown, Open
Back |
| Regulation Number: | 21 CFR §878.4040 |
| Device Class: | Class II |
| Regulation Name: | Surgical Apparel |
| Common/Classification Name: | Surgical Gown |
| Product Codes: | FYA |
| Predicate Device: | Kimberly-Clark Procedure Gown (K052824) |

6

Description

The Cardinal Health™ ChemoPlus™ Full Coverage Closed Back and Open Back Gowns are classified as Class II medical devices under Regulation 21 CFR 878.4040, General & Plastic Surgery Panel, FDA product code FYA, Surgical Gown.

The device description of the Cardinal Health™ ChemoPlus™ Gowns is in accordance with the Guidance on Premarket Notification [510(k)] Submissions for Surgical Gowns and Surgical Drapes, issued on August 1, 1993 and Guidance for Industry and FDA Staff: Premarket Notification Requirements Concerning Gowns Intended for Use in Healthcare Settings, issued on December 9, 2015.

The ChemoPlus™ Full Coverage Closed Back and Open Back Gowns are made of a laminate with adhesive taped seams. Both closed and open back gowns have a hook and loop closure at the back of the neck and a waist tie feature to secure the gown to the body of the user. The sleeves of the gown have knit cuffs sewn onto the end of the sleeve at the user's wrists to keep the sleeves in place on the wearer. The entire gown including the gown sleeves are made of the same material and utilize the same manufacturing processes.

| Catalog

Number	Product Description	Size	Sterility
CT5502T	Cardinal Health™ ChemoPlus™ Full Coverage Gown Closed Back	M	Non-sterile
CT5503T	Cardinal Health™ ChemoPlus™ Full Coverage Gown Closed Back	L	Non-sterile
CT5504T	Cardinal Health™ ChemoPlus™ Full Coverage Gown Closed Back	XL	Non-sterile
CT5505T	Cardinal Health™ ChemoPlus™ Full Coverage Gown Closed Back	XXL	Non-sterile
CT5502TS	Cardinal Health™ ChemoPlus™ Full Coverage Gown Closed Back	M	Sterile
CT5503TS	Cardinal Health™ ChemoPlus™ Full Coverage Gown Closed Back	L	Sterile
CT5504TS	Cardinal Health™ ChemoPlus™ Full Coverage Gown Closed Back	XL	Sterile
CT5505TS	Cardinal Health™ ChemoPlus™ Full Coverage Gown Closed Back	XXL	Sterile
DP5003GT	Cardinal Health™ ChemoPlus™ Full Coverage Gown Open Back	M	Non-sterile
DP5001GT	Cardinal Health™ ChemoPlus™ Full Coverage Gown Open Back	L	Non-sterile
DP5002GT	Cardinal Health™ ChemoPlus™ Full Coverage Gown Open Back	XL	Non-sterile
DP5004GT	Cardinal Health™ ChemoPlus™ Full Coverage Gown Open Back	XXL	Non-sterile

ChemoPlus™ Gowns Catalog Number Summary

7

Indications for Use

The Cardinal Health™ ChemoPlus™ Full Coverage Gowns, Closed Back, are intended to protect healthcare personnel from exposure to chemotherapy drugs during preparation, handling, and administration. The closed back gowns are single use, disposable medical devices provided sterile and non- sterile. The non-sterile, closed back gowns are not intended for use in the operating room.

The Cardinal Health™ ChemoPlus™ Full Coverage Gowns, Open Back, are intended to protect healthcare personnel from exposure to chemotherapy drugs during preparation, handling, and administration. The open back gowns are single use, disposable medical devices provided non-sterile. The open back gown is nonprotective in the back. The open back gowns are not intended for use in the operating room.

| Catalog

Number	Product Description	Size	Sterility
CT5502T	Cardinal Health™ ChemoPlus™ Full Coverage Gown Closed Back	M	Non-sterile
CT5503T	Cardinal Health™ ChemoPlus™ Full Coverage Gown Closed Back	L	Non-sterile
CT5504T	Cardinal Health™ ChemoPlus™ Full Coverage Gown Closed Back	XL	Non-sterile
CT5505T	Cardinal Health™ ChemoPlus™ Full Coverage Gown Closed Back	XXL	Non-sterile
CT5502TS	Cardinal Health™ ChemoPlus™ Full Coverage Gown Closed Back	M	Sterile
CT5503TS	Cardinal Health™ ChemoPlus™ Full Coverage Gown Closed Back	L	Sterile
CT5504TS	Cardinal Health™ ChemoPlus™ Full Coverage Gown Closed Back	XL	Sterile
CT5505TS	Cardinal Health™ ChemoPlus™ Full Coverage Gown Closed Back	XXL	Sterile
DP5003GT	Cardinal Health™ ChemoPlus™ Full Coverage Gown Open Back	M	Non-sterile
DP5001GT	Cardinal Health™ ChemoPlus™ Full Coverage Gown Open Back	L	Non-sterile
DP5002GT	Cardinal Health™ ChemoPlus™ Full Coverage Gown Open Back	XL	Non-sterile
DP5004GT	Cardinal Health™ ChemoPlus™ Full Coverage Gown Open Back	XXL	Non-sterile

ChemoPlus™ Gowns Catalog Number Summary

The proposed gowns meet the barrier protection requirements of AAMI Level 3 per ANSI/AAMI Standard PB70:2012 Liquid Barrier Performance and Classification of Protective Apparel and Drapes Intended for Use in Health Care Facilities.

8

The gowns have been evaluated for resistance to permeation of various chemotherapy drugs per ASTM F739-12, Standard Test Method for Permeation of Liquids and Gases Through Protective Clothing Materials Under Conditions of Continuous Contact.

Chemotherapy drug permeation resistance, average standardized breakthrough time in minutes *:

Carmustine [3.3 mg/ml] >480 Cisplatin [1.0 mg/ml] >480 Cyclophosphamide [20 mg/ml] >480 Cytarabine Hydrochloride [100 mg/ml] >480 Dacarbazine [10 mg/ml] >480 Daunorubicin Hydrochloride [5 mg/ml] >480 Doxorubicin Hydrochloride [2 mg/ml] >480 Etopside [20 mg/ml] >480 Fluorouracil [50 mg/ml] >480 Ifosfamide [50 mg/ml] >480 Methotrexate [25 mg/ml] >480 Mitomycin C [0.5 mg/ml] >480 Mitoxantrone [2.0 mg/ml] >480 Paclitaxel [6 mg/ml] >480 Thiotepa [10 mg/ml] >480 Vincristine Sulfate [1 mg/ml] >480

*No permeation was detected at either the minimum detectable permeation or 0.1 µg/cm²/min

When chemotherapy drugs are present, gown selection should be based on the specific type(s) of chemicals used. Users are recommended to review drug labeling or material safety data sheets for the chemicals being used to determine an adequate level of protection.

9

Technological Characteristics Comparison Tables

Shown below is the technological characteristics comparison of the subject or proposed device and the predicate device. Refer to Table 1 and Table 2.

| Element of
Comparison | Predicate Device:
K052824 Kimberly-
Clark Procedure
Gown | Proposed Device:
K193327 Cardinal Health™
ChemoPlus™ Full Coverage Gowns,
Closed Back | Comparison: |
|--------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------|
| Intended Use | The Kimberly-Clark
Procedure Gown is a non-
sterile, disposable, single
use item of apparel intended
to be worn by healthcare
professionals during the
preparation and
administration of selected
chemotherapy drugs. The
gown is not intended to be
worn during surgical
procedures. | The Cardinal Health™ ChemoPlus™ Full
Coverage Gowns, Closed Back, are intended
to protect healthcare personnel from
exposure to chemotherapy drugs during
preparation, handling, and administration.

The closed back gowns are single use,
disposable medical devices provided sterile
and non-sterile. The non-sterile, closed back
gowns are not intended for use in the
operating room. | Similar |
| Indications for
Use | Not available in the
predicate device 510(k)
Summary | The proposed gowns meet the barrier
protection requirements of AAMI Level 3
per ANSI/AAMI Standard PB70:2012
Liquid Barrier Performance and
Classification of Protective Apparel and
Drapes intended for use in Health Care
Facilities.

The gowns have been evaluated for
resistance to permeation of various
chemotherapy drugs per ASTM F739-12,
Standard Test Method for Permeation of
Liquids and Gases Through Protective
Clothing Materials Under
Conditions of Continuous Contact.

Chemotherapy drug permeation resistance,
average standardized breakthrough time in
minutes *:

Carmustine [3.3 mg/ml] >480
Cisplatin [1.0 mg/ml] >480
Cyclophosphamide [20 mg/ml] >480
Cytarabine Hydrochloride [100 mg/ml] >480
Dacarbazine [10 mg/ml] >480
Daunorubicin Hydrochloride [5 mg/ml] >480
Doxorubicin Hydrochloride [2 mg/ml] >480
Etopside [20 mg/ml] >480 | Similar |
| Element of
Comparison | Predicate Device:
K052824 Kimberly-
Clark Procedure Gown | Proposed Device:
K193327 Cardinal HealthTM
ChemoPlusTM Full Coverage Gowns,
Closed Back | Comparison: |
| | | Fluorouracil [50 mg/ml] >480
Ifosfamide [50 mg/ml] >480
Methotrexate [25 mg/ml] >480
Mitomycin C [0.5 mg/ml] >480
Mitoxantrone [2.0 mg/ml] >480
Paclitaxel [6 mg/ml] >480
Thiotepa [10 mg/ml] >480
Vincristine Sulfate [1 mg/ml] >480 | |
| | | *No permeation was detected at either the
minimum detectable permeation or 0.1
µg/cm²/min | |
| | | When chemotherapy drugs are present, gown
selection should be based on the specific
type(s) of chemicals used. Users are
recommended to review drug labeling or
material safety data sheets of the chemicals
being used to determine an adequate level of
protection. | |
| Directions for
Use | None | None | Same |
| Material
Composition | Nonwoven polypropylene
spunbond fabric with a
polyethylene laminate coating. | Nonwoven polypropylene spunbond fabric
with a polyethylene laminate coating (also
referred to as laminate) | Similar |
| Design Features | Knit Cuff
Tape-Tab Neck Closure
Belt Ties | Polyester Knit cuff
Hook and Loop Neck Closure
Belt Ties integrated in the back of gown
Taped seams | Similar |
| Sterility | Non-sterile | Sterile and Non-sterile | Similar |
| Use | Single Use; Disposable | Single Use; Disposable | Same |
| Color | Blue | Blue | Similar |
| Gown Style | Open Back | Closed Back | Similar |
| Element of
Comparison | Predicate Device:
K052824 Kimberly-
Clark Procedure Gown | Proposed Device:
K193327 Cardinal HealthTM
ChemoPlusTM Full Coverage Gowns,
Open Back | Comparison: |
| Intended Use | The Kimberly-Clark
Procedure Gown is a non-
sterile, disposable, single use
item of apparel intended to be
worn by healthcare
professionals during the
preparation and administration
of selected chemotherapy
drugs. The gown is not
intended to be worn during
surgical procedures. | The Cardinal HealthTM ChemoPlusTM Full
Coverage Gowns, Open Back, are intended
to protect healthcare personnel from
exposure to chemotherapy drugs during
preparation, handling, and administration.
The open back gowns are single use,
disposable medical devices provided non-
sterile. The open back gown is nonprotective
in the back. The open back gowns are not
intended for use in the operating room. | Similar |
| Indications for
Use | Not available in the predicate
device 510(k) Summary | The proposed gowns meet the barrier
protection requirements of AAMI Level 3
per ANSI/AAMI Standard PB70:2012
Liquid Barrier Performance and
Classification of Protective Apparel and
Drapes intended for use in Health Care
Facilities.
The gowns have been evaluated for
resistance to permeation of various
chemotherapy drugs per ASTM F739-12,
Standard Test Method for Permeation of
Liquids and Gases Through Protective
Clothing Materials Under
Conditions of Continuous Contact.
Chemotherapy drug permeation resistance,
average standardized breakthrough time in
minutes *:
Carmustine [3.3 mg/ml] >480
Cisplatin [1.0 mg/ml] >480
Cyclophosphamide [20 mg/ml] >480
Cytarabine Hydrochloride [100 mg/ml] >480
Dacarbazine [10 mg/ml] >480
Daunorubicin Hydrochloride [5 mg/ml] >480
Doxorubicin Hydrochloride [2 mg/ml] >480
Etopside [20 mg/ml] >480
Fluorouracil [50 mg/ml] >480
Ifosfamide [50 mg/ml] >480
Methotrexate [25 mg/ml] >480
Mitomycin C [0.5 mg/ml] >480
Mitoxantrone [2.0 mg/ml] >480
Paclitaxel [6 mg/ml] >480
Thiotepa [10 mg/ml] >480
Vincristine Sulfate [1 mg/ml] >480 | Similar |
| Element of
Comparison | Predicate Device:
K052824 Kimberly-
Clark Procedure Gown | Proposed Device:
K193327 Cardinal Health™
ChemoPlus™ Full Coverage Gowns,
Open Back | Comparison: |
| | | *No permeation was detected at either the
minimum detectable permeation or 0.1 $\mu g/cm^2/min$

Table 1: Cardinal Health™ ChemoPlus™ Full Coverage Gowns, Closed Back

10

11

Table 2: Cardinal Health™ ChemoPlus™ Full Coverage Gowns, Open Back

12

13

Non-Clinical Performance Testing

Test results establish that the proposed devices meet acceptance criteria for its intended use and demonstrate that each device is as safe and as effective as the predicate device.

Refer to the Summary of Non-Clinical Performance Testing, Table 1 and Table 2 below. The tables include a summary of the non-clinical performance testing and followed by a comparison of the predicate and proposed devices.

Summary of Non-Clinical Performance Testing

Standards	Purpose	Acceptance Criteria	Results
AATCC 42	Spray Impact	Water Resistance	PASS
AATCC 127	Hydrostatic Pressure	Water Resistance	PASS
ANSI/AAMI PB70:2012
AAMI Level 3	Liquid Barrier
Performance	Water Resistance	PASS
ASTM F739-12	Permeation of
Liquids and Gasses
through Protective
Clothing	Chemical Permeation
Under Continuous Contact	PASS
ASTM D3776/D3776M-17	Weight of Woven
Fabric	Material Weight	PASS
ASTM D5034 - 9
2017	Grab Tensile, Peak
Stretch, and Peak
Energy –
Nonwovens	Tensile Strength	PASS
ASTM 1683-17 (2018)	Standard Test
Method for Failure
in Sewn Seams of
Woven Apparel
Fabrics	Seam Strength	PASS

Table 1: Cardinal Health™ ChemoPlus™ Full Coverage Gowns, Closed Back

14

| ASTM D5587-15 (2019) | Standard Test
Method for Tearing
Strength of Fabrics
by the Trapezoid
Procedure | Trapezoid Tear | PASS |
|------------------------------|---------------------------------------------------------------------------------------------|----------------------|------|
| NWSP 160.1 | Resistance to
Linting of
Nonwoven Fabrics
(Dry) | Particulate | PASS |
| 16 CFR 1610 | Standard for the
Flammability for
Clothing Textiles | Flammability | PASS |
| ISO 10993-5:2009 | ISO MEM Elution
Cytotoxicity | Cytotoxicity | PASS |
| ISO 10993 10:2010 | ISO Indirect
Primary Skin
Irritation Test | Irritation | PASS |
| ISO 10993-10:2010 | Guinea Pig
Maximization Test | Sensitization | PASS |
| ISO 10993-7:2008 (R)
2012 | EO Sterilization
Residuals (Sterile
Catalog Numbers) | EO and ECH Residuals | PASS |

15

| Element of
Comparison | Predicate Device:
K052824 Kimberly-Clark
Procedure Gown | Proposed Device:
K193327 Cardinal Health™
ChemoPlus™ Full Coverage
Gowns, Closed Back | Comparison: |
|---------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------|
| Liquid Barrier
Performance
Classification
Properties | Penetration testing per ASTM
F1670-03 with resistance of the
gown fabric to penetration by blood
under conditions of continuous
liquid contact. The 'pass'
determination was based on visual
detection of synthetic blood
penetration.

Penetration testing per ASTM
F1671-03 with resistance of the
gown fabric to penetration by blood
borne pathogen under conditions of
continuous liquid contact. The
'pass' determination was based on
detection of viral penetration. | The proposed device meets the barrier
protection requirements of AAMI Level
3 per ANSI/AAMI PB70:2012, Liquid
Barrier Performance and Classification
of Protective Apparel and Drapes
Intended for Use in Health Care
Facilities. | Different |
| Biocompatibility | Dermal Irritation and Sensitization:
No evidence of dermal irritation or
allergic contact sensitization. | Under the conditions of each study, the
Cardinal Health™ ChemoPlus™ Full
Coverage Gown, Closed Back is non-
cytotoxic, non-irritating and non-
sensitizing and have met the requirements
per ISO-10993-1. | Similar |
| Liquid Chemical
Permeation | Permeation testing per ASTM
F739-99a with the following
chemotherapy drugs: Carmustine,
Cisplatin, Cyclophosphamide,
dacarbazine, doxorubicin
hydrochloride, etoposide,
fluorouracil, paclitaxel, Thiotepa,
and vincristine sulfate. Results
showed no permeation of the drugs
for up to 240 minutes. | These proposed gowns have been
evaluated for the following
chemotherapy drugs according to
ASTM F739-12: Carmustine, Cisplatin,
Cyclophosphamide, Cytarabine,
Dacarbazine, Daunorubicin,
Doxorubicin Hydrochloride, Etoposide,
Fluorouracil, Ifosfamide, Methotrexate,
Mitomycin C, Mitoxantrone, Paclitaxel,
Thiotepa, Vincristine Sulfate. Results
showed no average standardized
breakthrough for up to 480 minutes. | Similar |
| Sterilization
Modality | None, non-sterile | None, non-sterile
Ethylene Oxide (EO) Sterilization for
sterile catalog numbers. | Similar |
| Flammability | Meets Class I flammability
requirements per NFPA Standard
#702-1980** | Meet Class I Flammability per CPSC,
Part 1610 | Similar |

**Flammability standard, NFPA 702-1980 is now an inactive standard. NFPA 702-1980 has since been replaced by CPSC Part 1610 to evaluate the flammability class of protective apparel.

16

Summary of Non-Clinical Performance Testing

Table 2: Cardinal Health™ ChemoPlus™ Full Coverage Gowns, Open Back

Standards	Purpose	Acceptance Criteria	Results
AATCC 42	Spray Impact	Water Resistance	PASS
AATCC 127	Hydrostatic
Pressure	Water Resistance	PASS
ANSI/AAMI PB70:2012
AAMI Level 3	Liquid Barrier
Performance	Water Resistance	PASS
ASTM F739-12	Permeation of
Liquids and
Gasses through
Protective
Clothing	Chemical Permeation
Under Continuous
Contact	PASS
ASTM D3776/D3776M-
17	Weight of Woven
Fabric	Material Weight	PASS
ASTM D5034 - 9
2017	Grab Tensile,
Peak Stretch, and
Peak Energy -
Nonwovens	Tensile Strength	PASS
ASTM 1683-17 (2018)	Standard Test
Method for
Failure in Sewn
Seams of Woven
Apparel Fabrics	Seam Strength	PASS
ASTM D5587-15 (2019)	Standard Test
Method for
Tearing Strength
of Fabrics by the
Trapezoid
Procedure	Trapezoid Tear	PASS
NWSP 160.1	Resistance to
Linting of
Nonwoven Fabrics
(Dry)	Particulate	PASS
16 CFR 1610	Standard for the
Flammability for
Clothing Textiles	Flammability	PASS
ISO 10993-5:2009	ISO MEM Elution
Cytotoxicity	Cytotoxicity	PASS
ISO 10993 10:2010	ISO Indirect
Primary Skin
Irritation Test	Irritation	PASS
ISO 10993-10:2010	Guinea Pig
Maximization
Test	Sensitization	PASS

17

18

Element of	Predicate Device:	Proposed Device:	Comparison:
Comparison	K052824 Kimberly-Clark	Cardinal HealthTM ChemoPlusTM
	Procedure Gown	Full Coverage Gowns, Open Back
Liquid Barrier
Performance
Classification
Properties	Penetration testing per ASTM
F1670-03 with resistance of the
gown fabric to penetration by blood
under conditions of continuous
liquid contact. The 'pass'
determination was based on visual
detection of synthetic blood
penetration.
Penetration testing per ASTM
F1671-03 with resistance of the
gown fabric to penetration by blood
borne pathogen under conditions of
continuous liquid contact. The
'pass' determination was based on
detection of viral penetration.	The proposed device meets the barrier
protection requirements of AAMI Level
3 per ANSI/AAMI PB70:2012, Liquid
Barrier Performance and Classification
of Protective Apparel and Drapes
Intended for Use in Health Care
Facilities. The ChemoPlusTM Full
Coverage Open Back Gown has an open
back which is non-protective.	Different
Biocompatibility	Dermal Irritation and Sensitization:
No evidence of dermal irritation or
allergic contact sensitization.	Under the conditions of each study, the
Cardinal HealthTM ChemoPlusTM Full
Coverage Gown, Open Back is non-
cytotoxic, non-irritating and non-
sensitizing and have met the
requirements per ISO-10993-1.	Similar
Liquid Chemical
Permeation	Permeation testing per ASTM
F739-99a with the following
chemotherapy drugs: Carmustine,
Cisplatin, Cyclophosphamide,
dacarbazine, doxorubicin
hydrochloride, etoposide,
fluorouracil, paclitaxel, Thiotepa,
and vincristine sulfate. Results
showed no permeation of the drugs
for up to 240 minutes.	These proposed gowns have been
evaluated for the following
chemotherapy drugs according to
ASTM F739-12: Carmustine, Cisplatin,
Cyclophosphamide, Cytarabine,
Dacarbazine, Daunorubicin,
Doxorubicin Hydrochloride, Etoposide,
Fluorouracil, Ifosfamide, Methotrexate,
Mitomycin C, Mitoxantrone, Paclitaxel,
Thiotepa, Vincristine Sulfate. Results
showed no average standardized
breakthrough for up to 480 minutes.	Similar
Sterilization
Modality	None, non-sterile	None, non-sterile	Same
Flammability	Meets Class I flammability
requirements per NFPA Standard
#702-1980**	Meet Class I Flammability per CPSC,
Part 1610	Similar

**Flammability standard, NFPA 702-1980 is now an inactive standard. NFPA 702-1980 has since been replaced by CPSC Part 1610 to evaluate the flammability class of protective apparel.

19

The following standards were evaluated for the Cardinal Health™ ChemoPlus™ Full Coverage Gowns, both Open and Closed Back to further characterize these devices.

Standard Number	Standard Title
ANSI/AAMI
PB70:2012	Liquid Barrier Performance and Classification of Protective Apparel and
Drapes Intended for Use in Health Care Facilities.
ASTM
D3776/D3776M-17	Test Methods for Mass Per Unit Area (Weight) of Woven Fabric
ASTM D5034-09
(2017)	Standard Test Method for Breaking Strength and Elongation of Textile
Fabrics (Grab Test)
ASTM 1683-17
(2018)	Standard Test Method for Failure in Sewn Seams of Woven Apparel
Fabrics
ASTM D5587-15
(2019)	Standard Test Method for Tearing Strength of Fabrics by the Trapezoid
Procedure
NWSP 160.1	Resistance to Linting of Nonwoven Fabrics (Dry)
AATCC 127-2017	Water Resistance: Hydrostatic Pressure Test
AATCC 42-2017	Water Resistance: Water Impact Test
16 CFR Part 1610	Standard for the Flammability of Clothing Textiles (2016)
ASTM F739-12	Standard Test Method for Permeation of Liquids and Gases through
Protective Clothing Materials under Conditions of Continuous Contact
ISO 10993-5:2009	Biological Evaluation of Medical Devices- Part 5: Tests for In-Vitro
Cytotoxicity
ISO 10993-
10:2010	Biological Evaluation of Medical Devices- Part 10: Tests for irritation
and delayed-type hypersensitivity
ISO 10993-7:2008 (R)
2012	EO Sterilization Residues, Section 4.3.3 - Limited Exposure
Devices.

List of Standard Test Methods Performed

20

Conclusion

The Cardinal Health™ ChemoPlus™ Full Coverage Gown, Closed Back and the Cardinal Health™ ChemoPlus™ Full Coverage Gown, Open Back gowns are as safe, as effective and perform as well as or better than the legally marketed predicate device identified in this submission.