(109 days)
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.
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.
The provided text is a 510(k) Summary for the Cardinal Health™ ChemoPlus™ Full Coverage Gowns, indicating that these are medical devices subject to FDA regulation. The document describes non-clinical performance testing for these gowns.
It's important to note that this document pertains to physical medical devices (gowns), not an AI/ML powered device or a software as a medical device (SaMD). Therefore, many of the typical acceptance criteria and study components relevant to AI/ML devices (like sample size for test sets, data provenance, number of experts for ground truth, adjudication methods, MRMC studies, standalone performance, training set details, etc.) are not applicable in this context.
The study described is a series of non-clinical, laboratory-based performance tests conducted on the gowns themselves, adhering to specific industry standards.
Here's the information from the document relevant to acceptance criteria and the study that proves the device meets them:
1. A table of acceptance criteria and the reported device performance
| Standards Type | Purpose | Acceptance Criteria | Reported Device Performance |
|---|---|---|---|
| Liquid Barrier | |||
| 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 (AAMI Level 3 requirements) | PASS |
| Chemical Permeation | |||
| ASTM F739-12 | Permeation of Liquids and Gases through Protective Clothing | Chemical Permeation Under Continuous Contact | PASS (>480 minutes breakthrough for specified chemotherapy drugs with no permeation detected at minimum detectable permeation or 0.1 µg/cm²/min) |
| Material Properties | |||
| 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 |
| Flammability | |||
| 16 CFR 1610 | Standard for the Flammability for Clothing Textiles | Flammability (Meet Class I) | PASS |
| Biocompatibility | |||
| ISO 10993-5:2009 | ISO MEM Elution Cytotoxicity | Cytotoxicity (Non-cytotoxic) | PASS |
| ISO 10993 10:2010 | ISO Indirect Primary Skin Irritation Test | Irritation (Non-irritating) | PASS |
| ISO 10993-10:2010 | Guinea Pig Maximization Test | Sensitization (Non-sensitizing) | PASS |
| Sterilization Residuals | |||
| ISO 10993-7:2008 (R) 2012 | EO Sterilization Residuals (Sterile Catalog Numbers) | EO and ECH Residuals | PASS |
Study Proving Acceptance Criteria:
The study involved "Non-Clinical Performance Testing" of the Cardinal Health™ ChemoPlus™ Full Coverage Gowns (both closed and open back). This testing was conducted according to various recognized industry standards (AAMI, ASTM, AATCC, NWSP, CFR, ISO) to evaluate specific properties of the gowns. The results for all tests, as reported in the document, uniformly indicated "PASS," demonstrating that the proposed devices meet the acceptance criteria for their intended use.
Specific details for the chemical permeation test (ASTM F739-12) include:
- Chemotherapy drugs tested: Carmustine, Cisplatin, Cyclophosphamide, Cytarabine Hydrochloride, Dacarbazine, Daunorubicin Hydrochloride, Doxorubicin Hydrochloride, Etoposide, Fluorouracil, Ifosfamide, Methotrexate, Mitomycin C, Mitoxantrone, Paclitaxel, Thiotepa, Vincristine Sulfate.
- Reported performance: Average standardized breakthrough time for all tested chemotherapy drugs was ">480 minutes."
- Detection limit: No permeation was detected at either the minimum detectable permeation or 0.1 µg/cm²/min for any of the tested drugs.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided in the document. The tests are non-clinical, material performance tests, where "sample size" would refer to the number of gown material specimens tested according to the specific test standard's requirements, rather than patient data. Data provenance (country, retrospective/prospective) is not relevant for this type of materials testing.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This is not applicable. The "ground truth" for material performance criteria is established by the accepted scientific and engineering principles embedded in the referenced ASTM, ISO, AAMI, etc., standards, and the measurement equipment used for testing. It does not involve human expert consensus in the way an AI/ML medical image analysis device would.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This is not applicable as the evaluation is based on objective measurements against defined technical standards, not subjective human interpretations.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
This is not applicable. This is not an AI/ML device, nor does it involve human readers or diagnostic tasks.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is not applicable. This is not an AI/ML algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for these tests is defined by the objective measurement protocols and acceptance limits set forth in the various referenced international and national standards (e.g., AATCC 42, ASTM F739-12, ISO 10993-5:2009). For example, chemical permeation is measured directly using analytical methods, not expert consensus or pathology.
8. The sample size for the training set
This is not applicable. This is not an AI/ML device that requires a training set.
9. How the ground truth for the training set was established
This is not applicable. This is not an AI/ML device that requires a training set or ground truth for training.
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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
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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.
| CatalogNumber | 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
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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.
| CatalogNumber | 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)
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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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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, LLC3651 Birchwood DriveWaukegan, IL 60085 |
|---|---|
| Regulatory Affairs Contact: | Caroline Miceli3651 Birchwood DriveWaukegan, 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, ClosedBackCardinal Health™ ChemoPlus™ Full Coverage Gown, OpenBack |
| 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.
| CatalogNumber | 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
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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.
| CatalogNumber | 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 ofComparison | Predicate Device:K052824 Kimberly-Clark ProcedureGown | Proposed Device:K193327 Cardinal Health™ChemoPlus™ Full Coverage Gowns,Closed Back | Comparison: |
|---|---|---|---|
| Intended Use | The Kimberly-ClarkProcedure Gown is a non-sterile, disposable, singleuse item of apparel intendedto be worn by healthcareprofessionals during thepreparation andadministration of selectedchemotherapy drugs. Thegown is not intended to beworn during surgicalprocedures. | The Cardinal Health™ ChemoPlus™ FullCoverage Gowns, Closed Back, are intendedto protect healthcare personnel fromexposure to chemotherapy drugs duringpreparation, handling, and administration.The closed back gowns are single use,disposable medical devices provided sterileand non-sterile. The non-sterile, closed backgowns are not intended for use in theoperating room. | Similar |
| Indications forUse | Not available in thepredicate device 510(k)Summary | The proposed gowns meet the barrierprotection requirements of AAMI Level 3per ANSI/AAMI Standard PB70:2012Liquid Barrier Performance andClassification of Protective Apparel andDrapes intended for use in Health CareFacilities.The gowns have been evaluated forresistance to permeation of variouschemotherapy drugs per ASTM F739-12,Standard Test Method for Permeation ofLiquids and Gases Through ProtectiveClothing Materials UnderConditions of Continuous Contact.Chemotherapy drug permeation resistance,average standardized breakthrough time inminutes *:Carmustine [3.3 mg/ml] >480Cisplatin [1.0 mg/ml] >480Cyclophosphamide [20 mg/ml] >480Cytarabine Hydrochloride [100 mg/ml] >480Dacarbazine [10 mg/ml] >480Daunorubicin Hydrochloride [5 mg/ml] >480Doxorubicin Hydrochloride [2 mg/ml] >480Etopside [20 mg/ml] >480 | Similar |
| Element ofComparison | Predicate Device:K052824 Kimberly-Clark Procedure Gown | Proposed Device:K193327 Cardinal HealthTMChemoPlusTM Full Coverage Gowns,Closed Back | Comparison: |
| Fluorouracil [50 mg/ml] >480Ifosfamide [50 mg/ml] >480Methotrexate [25 mg/ml] >480Mitomycin C [0.5 mg/ml] >480Mitoxantrone [2.0 mg/ml] >480Paclitaxel [6 mg/ml] >480Thiotepa [10 mg/ml] >480Vincristine Sulfate [1 mg/ml] >480 | |||
| *No permeation was detected at either theminimum detectable permeation or 0.1µg/cm²/min | |||
| When chemotherapy drugs are present, gownselection should be based on the specifictype(s) of chemicals used. Users arerecommended to review drug labeling ormaterial safety data sheets of the chemicalsbeing used to determine an adequate level ofprotection. | |||
| Directions forUse | None | None | Same |
| MaterialComposition | Nonwoven polypropylenespunbond fabric with apolyethylene laminate coating. | Nonwoven polypropylene spunbond fabricwith a polyethylene laminate coating (alsoreferred to as laminate) | Similar |
| Design Features | Knit CuffTape-Tab Neck ClosureBelt Ties | Polyester Knit cuffHook and Loop Neck ClosureBelt Ties integrated in the back of gownTaped 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 ofComparison | Predicate Device:K052824 Kimberly-Clark Procedure Gown | Proposed Device:K193327 Cardinal HealthTMChemoPlusTM Full Coverage Gowns,Open Back | Comparison: |
| Intended Use | The Kimberly-ClarkProcedure Gown is a non-sterile, disposable, single useitem of apparel intended to beworn by healthcareprofessionals during thepreparation and administrationof selected chemotherapydrugs. The gown is notintended to be worn duringsurgical procedures. | The Cardinal HealthTM ChemoPlusTM FullCoverage Gowns, Open Back, are intendedto protect healthcare personnel fromexposure to chemotherapy drugs duringpreparation, handling, and administration.The open back gowns are single use,disposable medical devices provided non-sterile. The open back gown is nonprotectivein the back. The open back gowns are notintended for use in the operating room. | Similar |
| Indications forUse | Not available in the predicatedevice 510(k) Summary | The proposed gowns meet the barrierprotection requirements of AAMI Level 3per ANSI/AAMI Standard PB70:2012Liquid Barrier Performance andClassification of Protective Apparel andDrapes intended for use in Health CareFacilities.The gowns have been evaluated forresistance to permeation of variouschemotherapy drugs per ASTM F739-12,Standard Test Method for Permeation ofLiquids and Gases Through ProtectiveClothing Materials UnderConditions of Continuous Contact.Chemotherapy drug permeation resistance,average standardized breakthrough time inminutes *:Carmustine [3.3 mg/ml] >480Cisplatin [1.0 mg/ml] >480Cyclophosphamide [20 mg/ml] >480Cytarabine Hydrochloride [100 mg/ml] >480Dacarbazine [10 mg/ml] >480Daunorubicin Hydrochloride [5 mg/ml] >480Doxorubicin Hydrochloride [2 mg/ml] >480Etopside [20 mg/ml] >480Fluorouracil [50 mg/ml] >480Ifosfamide [50 mg/ml] >480Methotrexate [25 mg/ml] >480Mitomycin C [0.5 mg/ml] >480Mitoxantrone [2.0 mg/ml] >480Paclitaxel [6 mg/ml] >480Thiotepa [10 mg/ml] >480Vincristine Sulfate [1 mg/ml] >480 | Similar |
| Element ofComparison | 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 theminimum detectable permeation or 0.1 $\mu g/cm^2/min$When chemotherapy drugs are present, gownselection should be based on the specifictype(s) of chemicals used. Users arerecommended to review drug labeling ormaterial safety data sheets of the chemicalsbeing used to determine an adequate level ofprotection. | |||
| Directions forUse | None | None | Same |
| MaterialComposition | Nonwoven polypropylenespunbond fabric with apolyethylene laminate coating. | Nonwoven polypropylene spunbond fabricwith a polyethylene laminate coating (alsoreferred to as laminate) | Similar |
| Design Features | Knit CuffTape-Tab Neck ClosureBelt Ties | Polyester Knit cuffHook and Loop Neck ClosureBelt Ties integrated in the back of gownTaped 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
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Table 2: Cardinal Health™ ChemoPlus™ Full Coverage Gowns, Open Back
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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 PB70:2012AAMI Level 3 | Liquid BarrierPerformance | Water Resistance | PASS |
| ASTM F739-12 | Permeation ofLiquids and Gassesthrough ProtectiveClothing | Chemical PermeationUnder Continuous Contact | PASS |
| ASTM D3776/D3776M-17 | Weight of WovenFabric | Material Weight | PASS |
| ASTM D5034 - 92017 | Grab Tensile, PeakStretch, and PeakEnergy –Nonwovens | Tensile Strength | PASS |
| ASTM 1683-17 (2018) | Standard TestMethod for Failurein Sewn Seams ofWoven ApparelFabrics | Seam Strength | PASS |
Table 1: Cardinal Health™ ChemoPlus™ Full Coverage Gowns, Closed Back
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| ASTM D5587-15 (2019) | Standard TestMethod for TearingStrength of Fabricsby the TrapezoidProcedure | Trapezoid Tear | PASS |
|---|---|---|---|
| NWSP 160.1 | Resistance toLinting ofNonwoven Fabrics(Dry) | Particulate | PASS |
| 16 CFR 1610 | Standard for theFlammability forClothing Textiles | Flammability | PASS |
| ISO 10993-5:2009 | ISO MEM ElutionCytotoxicity | Cytotoxicity | PASS |
| ISO 10993 10:2010 | ISO IndirectPrimary SkinIrritation Test | Irritation | PASS |
| ISO 10993-10:2010 | Guinea PigMaximization Test | Sensitization | PASS |
| ISO 10993-7:2008 (R)2012 | EO SterilizationResiduals (SterileCatalog Numbers) | EO and ECH Residuals | PASS |
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| Element ofComparison | Predicate Device:K052824 Kimberly-ClarkProcedure Gown | Proposed Device:K193327 Cardinal Health™ChemoPlus™ Full CoverageGowns, Closed Back | Comparison: |
|---|---|---|---|
| Liquid BarrierPerformanceClassificationProperties | Penetration testing per ASTMF1670-03 with resistance of thegown fabric to penetration by bloodunder conditions of continuousliquid contact. The 'pass'determination was based on visualdetection of synthetic bloodpenetration.Penetration testing per ASTMF1671-03 with resistance of thegown fabric to penetration by bloodborne pathogen under conditions ofcontinuous liquid contact. The'pass' determination was based ondetection of viral penetration. | The proposed device meets the barrierprotection requirements of AAMI Level3 per ANSI/AAMI PB70:2012, LiquidBarrier Performance and Classificationof Protective Apparel and DrapesIntended for Use in Health CareFacilities. | Different |
| Biocompatibility | Dermal Irritation and Sensitization:No evidence of dermal irritation orallergic contact sensitization. | Under the conditions of each study, theCardinal Health™ ChemoPlus™ FullCoverage Gown, Closed Back is non-cytotoxic, non-irritating and non-sensitizing and have met the requirementsper ISO-10993-1. | Similar |
| Liquid ChemicalPermeation | Permeation testing per ASTMF739-99a with the followingchemotherapy drugs: Carmustine,Cisplatin, Cyclophosphamide,dacarbazine, doxorubicinhydrochloride, etoposide,fluorouracil, paclitaxel, Thiotepa,and vincristine sulfate. Resultsshowed no permeation of the drugsfor up to 240 minutes. | These proposed gowns have beenevaluated for the followingchemotherapy drugs according toASTM F739-12: Carmustine, Cisplatin,Cyclophosphamide, Cytarabine,Dacarbazine, Daunorubicin,Doxorubicin Hydrochloride, Etoposide,Fluorouracil, Ifosfamide, Methotrexate,Mitomycin C, Mitoxantrone, Paclitaxel,Thiotepa, Vincristine Sulfate. Resultsshowed no average standardizedbreakthrough for up to 480 minutes. | Similar |
| SterilizationModality | None, non-sterile | None, non-sterileEthylene Oxide (EO) Sterilization forsterile catalog numbers. | Similar |
| Flammability | Meets Class I flammabilityrequirements 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.
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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 | HydrostaticPressure | Water Resistance | PASS |
| ANSI/AAMI PB70:2012AAMI Level 3 | Liquid BarrierPerformance | Water Resistance | PASS |
| ASTM F739-12 | Permeation ofLiquids andGasses throughProtectiveClothing | Chemical PermeationUnder ContinuousContact | PASS |
| ASTM D3776/D3776M-17 | Weight of WovenFabric | Material Weight | PASS |
| ASTM D5034 - 92017 | Grab Tensile,Peak Stretch, andPeak Energy -Nonwovens | Tensile Strength | PASS |
| ASTM 1683-17 (2018) | Standard TestMethod forFailure in SewnSeams of WovenApparel Fabrics | Seam Strength | PASS |
| ASTM D5587-15 (2019) | Standard TestMethod forTearing Strengthof Fabrics by theTrapezoidProcedure | Trapezoid Tear | PASS |
| NWSP 160.1 | Resistance toLinting ofNonwoven Fabrics(Dry) | Particulate | PASS |
| 16 CFR 1610 | Standard for theFlammability forClothing Textiles | Flammability | PASS |
| ISO 10993-5:2009 | ISO MEM ElutionCytotoxicity | Cytotoxicity | PASS |
| ISO 10993 10:2010 | ISO IndirectPrimary SkinIrritation Test | Irritation | PASS |
| ISO 10993-10:2010 | Guinea PigMaximizationTest | Sensitization | PASS |
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| Element of | Predicate Device: | Proposed Device: | Comparison: |
|---|---|---|---|
| Comparison | K052824 Kimberly-Clark | Cardinal HealthTM ChemoPlusTM | |
| Procedure Gown | Full Coverage Gowns, Open Back | ||
| Liquid BarrierPerformanceClassificationProperties | Penetration testing per ASTMF1670-03 with resistance of thegown fabric to penetration by bloodunder conditions of continuousliquid contact. The 'pass'determination was based on visualdetection of synthetic bloodpenetration.Penetration testing per ASTMF1671-03 with resistance of thegown fabric to penetration by bloodborne pathogen under conditions ofcontinuous liquid contact. The'pass' determination was based ondetection of viral penetration. | The proposed device meets the barrierprotection requirements of AAMI Level3 per ANSI/AAMI PB70:2012, LiquidBarrier Performance and Classificationof Protective Apparel and DrapesIntended for Use in Health CareFacilities. The ChemoPlusTM FullCoverage Open Back Gown has an openback which is non-protective. | Different |
| Biocompatibility | Dermal Irritation and Sensitization:No evidence of dermal irritation orallergic contact sensitization. | Under the conditions of each study, theCardinal HealthTM ChemoPlusTM FullCoverage Gown, Open Back is non-cytotoxic, non-irritating and non-sensitizing and have met therequirements per ISO-10993-1. | Similar |
| Liquid ChemicalPermeation | Permeation testing per ASTMF739-99a with the followingchemotherapy drugs: Carmustine,Cisplatin, Cyclophosphamide,dacarbazine, doxorubicinhydrochloride, etoposide,fluorouracil, paclitaxel, Thiotepa,and vincristine sulfate. Resultsshowed no permeation of the drugsfor up to 240 minutes. | These proposed gowns have beenevaluated for the followingchemotherapy drugs according toASTM F739-12: Carmustine, Cisplatin,Cyclophosphamide, Cytarabine,Dacarbazine, Daunorubicin,Doxorubicin Hydrochloride, Etoposide,Fluorouracil, Ifosfamide, Methotrexate,Mitomycin C, Mitoxantrone, Paclitaxel,Thiotepa, Vincristine Sulfate. Resultsshowed no average standardizedbreakthrough for up to 480 minutes. | Similar |
| SterilizationModality | None, non-sterile | None, non-sterile | Same |
| Flammability | Meets Class I flammabilityrequirements 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.
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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/AAMIPB70:2012 | Liquid Barrier Performance and Classification of Protective Apparel andDrapes Intended for Use in Health Care Facilities. |
| ASTMD3776/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 TextileFabrics (Grab Test) |
| ASTM 1683-17(2018) | Standard Test Method for Failure in Sewn Seams of Woven ApparelFabrics |
| ASTM D5587-15(2019) | Standard Test Method for Tearing Strength of Fabrics by the TrapezoidProcedure |
| 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 throughProtective Clothing Materials under Conditions of Continuous Contact |
| ISO 10993-5:2009 | Biological Evaluation of Medical Devices- Part 5: Tests for In-VitroCytotoxicity |
| ISO 10993-10:2010 | Biological Evaluation of Medical Devices- Part 10: Tests for irritationand delayed-type hypersensitivity |
| ISO 10993-7:2008 (R)2012 | EO Sterilization Residues, Section 4.3.3 - Limited ExposureDevices. |
List of Standard Test Methods Performed
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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.
§ 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.