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

Q: Who is the manufacturer of Cardinal Health ChemoPlus Full Coverage Gown, Closed Back, Cardinal Health ChemoPlus Full Coverage Gown, Open Back, Cardinal Health ChemoPlus Full Coverage Sleeve?

Cardinal Health200, LLC filed the 510(k) submission for Cardinal Health ChemoPlus Full Coverage Gown, Closed Back, Cardinal Health ChemoPlus Full Coverage Gown, Open Back, Cardinal Health ChemoPlus Full Coverage Sleeve (K193327).

Q: What is the FDA product code for Cardinal Health ChemoPlus Full Coverage Gown, Closed Back, Cardinal Health ChemoPlus Full Coverage Gown, Open Back, Cardinal Health ChemoPlus Full Coverage Sleeve?

FYA. It is classified under 21 CFR 878.4040 as a Class 2 device in the General, Plastic Surgery panel.

Q: What is the regulatory pathway for Cardinal Health ChemoPlus Full Coverage Gown, Closed Back, Cardinal Health ChemoPlus Full Coverage Gown, Open Back, Cardinal Health ChemoPlus Full Coverage Sleeve?

510(k) clearance (submission type: Traditional).

Q: What are the predicate devices for Cardinal Health ChemoPlus Full Coverage Gown, Closed Back, Cardinal Health ChemoPlus Full Coverage Gown, Open Back, Cardinal Health ChemoPlus Full Coverage Sleeve?

Kimberly-Clark Procedure Gown (K052824).

Q: Who can help prepare an FDA 510(k) submission like Cardinal Health ChemoPlus Full Coverage Gown, Closed Back, Cardinal Health ChemoPlus Full Coverage Gown, Open Back, Cardinal Health ChemoPlus Full Coverage Sleeve?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

K193327 · Cardinal Health200, LLC · FYA · Mar 20, 2020 · General, Plastic Surgery

Device Facts

Record ID	K193327
Device Name	Cardinal Health ChemoPlus Full Coverage Gown, Closed Back, Cardinal Health ChemoPlus Full Coverage Gown, Open Back, Cardinal Health ChemoPlus Full Coverage Sleeve
Applicant	Cardinal Health200, LLC
Product Code	FYA · General, Plastic Surgery
Decision Date	Mar 20, 2020
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 878.4040
Device Class	Class 2

Intended 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.

Device Story

Disposable, single-use surgical-style gowns designed to protect healthcare personnel from chemotherapy drug exposure during preparation, handling, and administration. Constructed from nonwoven polypropylene spunbond fabric with polyethylene laminate coating; features include knit cuffs, hook-and-loop neck closures, and waist ties. Closed-back and open-back versions available; closed-back version provided sterile or non-sterile, open-back version provided non-sterile. Gowns meet AAMI Level 3 liquid barrier performance requirements. Used in clinical settings by healthcare staff; provides a physical barrier against liquid permeation. Performance validated against 16 chemotherapy drugs per ASTM F739-12, demonstrating breakthrough times >480 minutes. Gown selection depends on specific chemical agents used; users must consult drug safety data sheets.

Clinical Evidence

Bench testing only. No clinical data. Performance validated via AATCC 42 (spray impact), AATCC 127 (hydrostatic pressure), ANSI/AAMI PB70:2012 (liquid barrier), ASTM F739-12 (chemical permeation), ASTM D3776 (weight), ASTM D5034 (tensile strength), ASTM 1683 (seam strength), ASTM D5587 (tear strength), NWSP 160.1 (linting), 16 CFR 1610 (flammability), and ISO 10993 series (cytotoxicity, irritation, sensitization).

Technological Characteristics

Nonwoven polypropylene spunbond fabric with polyethylene laminate coating. AAMI Level 3 barrier performance per ANSI/AAMI PB70:2012. Polyester knit cuffs. Hook and loop neck closure. Sterilization via Ethylene Oxide (EO) for sterile catalog numbers. Complies with CPSC Part 1610 flammability standards.

Indications for Use

Indicated for healthcare personnel requiring protection from chemotherapy drug exposure during preparation, handling, and administration. Not for use in the operating room.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

Kimberly-Clark Procedure Gown (K052824)

Related Devices

K214108 — Medline Orbis Chemo Surgical Gown · Medline Industries, LP · May 6, 2022
K211036 — Plus Medical Chemotherapy Gown · Foshan Nanhai Plus Medical Co, Ltd. · May 4, 2022
K230135 — Copioumed Chemotherapy Isolation Gown · Copioumed International, Inc. · Oct 4, 2023
K210414 — CoverU Disposable Gown with Tape AAMI Level 4 Isolation Gown CoverU Disposable Gown with Tape - Chemo Gown · Medtecs (Taiwan) Corp. · Oct 21, 2022
K052824 — KIMBERLY-CLARK PROCEDURE GOWN · Kimberly-Clark Corp. · May 2, 2006

Submission Summary (Full Text)

{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) ### 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 0MB number." {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 $\mu g/cm^2/min$ 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 | Non-sterile | Same | | Use | Single Use; Disposable | Single Use; Disposable | Same | | Color | Blue | Blue | Similar | | Gown Style | Open Back | Open Back | Same | 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…