Copioumed Chemotherapy Isolation Gown is intended to be worn by healthcare personnel to protect health care patients and health care personnel from the transfer of microorganisms, body fluids and particulate. Copioumed Chemotherapy Isolation Gown is non-sterile and for single use only.

Copioumed Chemotherapy Isolation Gown meets the requirements of an AAMI Level 3 barrier protection for an isolation gown per ANSI/AAMI PB70:2012 Liquid Barrier Performance Classification of Protective Apparel Drapes Intended for Use in Health Care Facilities (ANSI/AAMI PB70).

Copioumed Chemotherapy Isolation Gown is a disposable device intended to protect health care personal from exposure to chemotherapy drugs during preparation, handling, and administration.

The Copioumed Chemotherapy Isolation Gown has been evaluated for resistance to permeation of various chemotherapy drugs per ASTM F739-20 "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
Etoposide [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 ug/cm2/min

Device Description

Copioumed Chemotherapy Isolation Gown is a disposable device intended to protect health care personal from exposure to chemotherapy drugs during preparation, handling, and administration. This device is non-sterile and for single use only. Copioumed Chemotherapy Isolation Gown is a Polypropylene Gown laminated with Polyethylene and Knit cuff in three styles: Tie neck closure, Velcro neck closure and Sticker neck closure.

AI/ML Overview

This document pertains to the 510(k) premarket notification for the "Copioumed Chemotherapy Isolation Gown," a Class II medical device. The information provided outlines the device's technical specifications, indications for use, and a comparison to predicate and reference devices, supported by non-clinical testing.

Here's an analysis of the acceptance criteria and study proving the device meets these criteria, as presented in the document:

1. Table of Acceptance Criteria and Reported Device Performance

The device's performance is primarily evaluated against recognized standards for protective apparel and chemotherapy drug permeation. The criteria and results are summarized in section "L. SUMMARY OF NON-CLINICAL TESTING" on page 14.

No.	Standards	Purpose	Criteria	Results
1.	AATCC 42	To demonstrate resistance to penetration of sprayed water	≤1.0 g	Pass
2.	AATCC 127	To demonstrate resistance to penetration of pressurized water	≥50 cm H2O	Pass
3.	ANSI/AAMI PB70:2012 AAMI Level 3	To demonstrate adequate liquid barrier performance	Level 3	Pass
4.	ASTM F739-20 (For specified chemotherapy drugs)	To demonstrate resistance to penetration of chemotherapy drugs	≥480 minutes (for each listed drug)	Pass
5.	ASTM D3776/D3776M-17	To determine the mass of the fabric	Informative (This standard does not have a pass/fail criterion; it's for characterization)	Pass (meaning the test was conducted)
6.	ASTM D5034 - 9 2017	To demonstrate adequate tensile strength of the material	≥30 N	Pass
7.	ASTM 1683-17 (2018)	To demonstrate adequate seam strength	≥30 N	Pass
8.	ASTM D5587-15 (2019)	To demonstrate adequate tear strength of the material	≥10 N	Pass
9.	NWSP 160.1	To determine the linting properties	Informative	Pass (meaning the test was conducted)
10.	ISO 9073-10:2003	To determine linting properties	Informative	Pass (meaning the test was conducted)
11.	16 CFR 1610	Standard for the Flammability for Clothing Textiles	Class 1	Pass
12.	ISO 10993-5:2009	To assess the potential cytotoxicity of the gown	Under the conditions of the testing, non-cytotoxic	Pass
13	ISO 10993-10:2021	To assess the sensitization potential of the gown	Under the conditions of the testing, not a sensitizer	Pass
14	ISO 10993-23:2021	To assess the irritation potential of the gown	Under the conditions of the testing, not an irritant	Pass

Chemotherapy Drug Permeation Resistance (detailed from page 3, 6, and 8):
The device was evaluated for resistance to permeation based on ASTM F739-20. The acceptance criterion for each drug was a breakthrough time of >480 minutes, with "No permeation was detected at either the minimum detectable permeation or 0.1 µg/cm²/min." The device met this criterion for all 16 listed chemotherapy drugs:

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

2. Sample Size Used for the Test Set and Data Provenance

The document does not specify the exact sample sizes (e.g., number of gowns or material samples) used for each specific non-clinical test. It only states that the tests were performed "under the test conditions" for biocompatibility and that results for physical tests (e.g., breaking strength, tearing strength) are given as means and standard deviations, implying multiple samples were tested.

The data provenance is from non-clinical laboratory testing. The document does not explicitly state the country of origin of the data or whether it was retrospective or prospective, beyond acknowledging that these are test results supporting a 510(k) submission. Given it's a 510(k) submission to the US FDA from a Taiwanese company (Copioumed International Inc.), the testing would have been conducted to meet US regulatory requirements, likely in certified labs.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

This submission is for a physical medical device (isolation gown) and relies entirely on non-clinical laboratory testing against recognized industry standards (ASTM, AAMI, ISO, AATCC, CFR). Therefore:

No human experts were used to establish ground truth in the context of clinical interpretation (e.g., radiologists for imaging data).
The "ground truth" is defined by the numerical criteria outlined in the referenced performance standards. The qualifications of the personnel conducting these laboratory tests would be that they are trained and competent in performing the specific standard tests in accredited laboratories. The document does not provide details on these personnel.

4. Adjudication Method for the Test Set

Not applicable. Since the evaluation is based on non-clinical, objective laboratory tests with defined quantitative pass/fail criteria, there is no team of experts adjudicating results in the way one would for clinical data or imaging interpretations. The tests yield objective measurements that are compared against a pre-defined standard's requirements.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No. This is a 510(k) submission for an isolation gown, not a software or AI-assisted diagnostic tool. MRMC studies are not relevant for this type of device.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Yes, in a sense. The "performance" of this device is its physical and chemical barrier properties and material strength. These are assessed in laboratory settings without human intervention in the loop beyond the initial setup and analysis of the test apparatus. The tests are designed to measure the inherent properties of the gown material and construction.

7. The Type of Ground Truth Used

The ground truth used for this device's performance evaluation is based on defined quantitative and qualitative criteria set by recognized consensus standards (e.g., AAMI PB70:2012 for liquid barrier performance, ASTM F739-20 for chemotherapy drug permeation, various ASTM standards for material strength, and ISO 10993 for biocompatibility). These standards specify the methodology and acceptance criteria for demonstrating the device's protective capabilities.

8. The Sample Size for the Training Set

Not applicable. This device is an isolation gown, not an AI/ML-based device that requires a training set. The evaluation is based on physical and chemical testing of the final product.

9. How the Ground Truth for the Training Set Was Established

Not applicable, as there is no training set for this device.

Summary

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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" followed by the words "U.S. Food & Drug Administration".

October 4, 2023

Copioumed International Inc. % Ming-Yie Jan Principle Consultant RusCert Technology Co., Ltd. 8F., No. 187, Lequn 2nd Rd., Zhongshan Dist. Taipei City, 10462 Taiwan

Re: K230135

Trade/Device Name: Copioumed Chemotherapy Isolation Gown Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical Apparel Regulatory Class: Class II Product Code: FYC, QSO Dated: August 28, 2023 Received: September 5, 2023

Dear Ming-Yie Jan:

We have reviewed your section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (the Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

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

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Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

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Sincerely,

Bifeng Qian -S

BiFeng Qian, M.D., Ph.D. 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) K230135

Device Name Copioumed Chemotherapy Isolation Gown

Indications for Use (Describe)

Copioumed Chemotherapy Isolation Gown is a disposable device intended to protect health care personal from exposure to chemotherapy drugs during preparation, handling, and administration.

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 Etoposide [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 ug/cm2/min

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.

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新萬盟有限公司

510(k) SUMMARY

A. 510(K) NUMBER	K230135
B. DATE PREPARED	September 27, 2023
C. SUBMITTER	COPIOUMED INTERNATIONAL INC.
D. CONTACT PERSON	Primary ContactTitle: General ManagerName: James LiuTel: + 886 928 644 966E-Mail: james.liu@gcv.com.twOfficial CorrespondentTitle: Principal ConsultantName: Ming-Yie JanTel: + 8886 2 8785 8989E-Mail: mingyie.jan@ruscert.net
E. SUBJECT DEVICE	Proprietary Name: Copioumed Chemotherapy Isolation GownProduct Code: FYC, QSOClassification Names: Gown, Isolation, Surgical; Medical Gowns WithChemotherapy Labeling Claims - Tested For Use WithChemotherapy DrugsRegulation Number 21 CFR 878.4040Regulation Name: Surgical ApparelDevice Class: Class IIReview Panel: General Hospital
F. INDICATIONS FORUSE	Copioumed Chemotherapy Isolation Gown is intended to be worn by healthcarepersonnel to protect health care patients and health care personnel from the transferof microorganisms, body fluids and particulate. Copioumed ChemotherapyIsolation Gown is non-sterile and for single use only.Copioumed Chemotherapy Isolation Gown meets the requirements of an AAMILevel 3 barrier protection for an isolation gown per ANSI/AAMI PB70:2012Liquid Barrier Performance Classification of Protective Apparel Drapes Intendedfor Use in Health Care Facilities (ANSI/AAMI PB70).Copioumed Chemotherapy Isolation Gown is a disposable device intended toprotect health care personal from exposure to chemotherapy drugs duringpreparation, handling, and administration.The Copioumed Chemotherapy Isolation Gown has been evaluated for resistanceto permeation of various chemotherapy drugs per ASTM F739-20 "Standard TestMethod for Permeation of Liquids and Gases Through Protective ClothingMaterials Under Conditions of Continuous Contact."

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新萬盟有限公司

		Chemotherapy drug permeation resistance, average standardized breakthrough timein minutes. *: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] > 480Etoposide [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
		*No permeation was detected at either the minimum detectable permeation or 0.1µg/cm2/min
	G. PREDICATEDEVICE	Proprietary Name: AMD Ritmed AssureWear VersaGownProduct Code: FYCRegulation Number: 21 CFR 878.4040Regulation Name: Surgical Apparel510(k) Number: K190306510(k) Submitter: AMD Medicom Inc.Device Class: Class IIReview Panel: General Hospital
	H. REFERENCEDEVICE	Proprietary Name: CoverU Disposable Gown with Tape - Chemo GownProduct Code: FYC, QSORegulation Number: 21 CFR 878.4040Regulation Name: Surgical Apparel510(k) Number: K210414510(k) Submitter: Medtecs (Taiwan) Corp.Device Class: Class IIReview Panel: General Hospital
	I. DEVICEDESCRIPTION	Copioumed Chemotherapy Isolation Gown is a disposable device intended toprotect health care personal from exposure to chemotherapy drugs duringpreparation, handling, and administration. This device is non-sterile and for singleuse only. Copioumed Chemotherapy Isolation Gown is a Polypropylene Gownlaminated with Polyethylene and Knit cuff in three styles: Tie neck closure, Velcroneck closure and Sticker neck closure.

K230135

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新萬盟有限公司

Elements ofComparison	Proposed Device:Copioumed ChemotherapyIsolation GownK230135	Predicate Device:AMD Ritmed AssureWearVersaGownK190306	Comparisons
Product Code	FYC, QSO	FYC	Same for FYC
IntendedUse/Indicationsfor Use	Copioumed ChemotherapyIsolation Gown is intended to beworn by healthcare personnel toprotect health care patients andhealth care personnel from thetransfer of microorganisms, bodyfluids and particulate. CopioumedChemotherapy Isolation Gown isnon- sterile and for single useonly.Copioumed ChemotherapyIsolation Gown meets therequirements of an AAMI Level 3barrier protection for an isolationgown per ANSI/AAMIPB70:2012 Liquid BarrierPerformance Classification ofProtective Apparel DrapesIntended for Use in Health CareFacilities (ANSI/AAMI PB70).Copioumed ChemotherapyIsolation Gown is a disposabledevice intended to protect healthcare personal fromexposure to chemotherapy drugsduring preparation, handling, andadministration.The Copioumed ChemotherapyIsolation Gown has been evaluatedfor resistance to permeation ofvarious chemotherapy drugs perASTM F739-20 "Standard TestMethod for Permeation of Liquidsand Gases Through ProtectiveClothing Materials UnderConditions of ContinuousContact "	AMD Ritmed Assure Wear™VersaGown is intended to beworn by healthcare personnelto protect health care patientsand health care personnel fromthe transfer ofmicroorganisms, body fluidsand particulate material.AssureWear™ VersaGownmeets the requirements of anAAMI Level 3 barrierprotection for an isolationgown per ANSI/AAMIPB70:2012 Liquid BarrierPerformance Classification ofProtective Apparel DrapesIntended for Use in HealthCareFacilities (ANSI/AAMIPB70). AMD RitmedAssureWear™ VersaGown isa single use, non-steriledisposable medical device andnot intended for use inoperating rooms. The medicaldevice will be available in 18models in large and X-largesizes.Flexneck Models FlexneckPlus Models Tie ModelsA69964 A69933 A8300A69965 A69934 A8301A69966 A69935 A8302A69967 A69936 A8303A69968 A69937 A8304A69969 A69938 A8305	Same:1. AAMILevel 3IsolationGowns2. Meet therequirementsof level 3Liquid BarrierPerformanceas per AAMIPB70:20123. Non-sterile andsingle useonly.Similar¹:1. ProtectiondescriptionDifferent¹:1. Evaluatedfor resistanceto permeationof variouschemotherapy

J. COMPARISON OF CHARACTERISTICS WITH THE PREDICATE DEVICE

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新萬盟有限公司

	Chemotherapydrug permeation resistance,average standardized breakthroughtime in minutes.:Carmustine [3.3 mg/ml] >480Cisplatin [1.0 mg/ml] >480Cyclophosphamide [20 mg/ml]>480Cytarabine Hydrochloride [100mg/ml]>480Dacarbazine [10 mg/ml] >480Daunorubicin Hydrochloride [5mg/ml]>480Doxorubicin Hydrochloride [2mg/ml] >480Etoposide [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]>480No permeation was detected ateither the minimum detectablepermeation or 0.1 µg/cm2/min
MaterialComposition	Polypropylene Gown laminatedwith polyethylene	PP SMS non-woven + PE	Similar2
Design Features	Knit cuff in three style(model) Tieneck closure, Velcro neck closureand Sticker neck closure	Thumb loop Elastic cuffsExtended cuff (Thumb loop)Flexneck™Tie (neck)Straight sleeve Inclined sleeveBlue belt tie	Similar3
Sterility	Non-sterile	Non-sterile	Same
Color	Blue	Blue	Same
Use	OTC	OTC	Same
Contact Durations	Surface, < 24 hours	Surface, < 24 hours	Same
Disposable	Disposable	Disposable	Same
SingleUse/Reusable	Single Use	Single Use	Same
Performance perAAMI PB70:2012	AAMI Level 3	AAMI Level 3	Same
Basis weightASTM D3776	51.2 ± 1.2 g/m²(1.5 oz/yd² ± 0.04)	39.97 ± 1.61 g/m²(1.17 oz/yd² ± 0.05)	Similar5
Liquid barrierperformance:HydrostaticPressure AATCC127	Pass.Met the standard's requirement (≥50 cm H2 O)Testing targets: main body fabric,sleeve seam, shoulder seam, belt,armpit	Chest: 109.34 ± 0.34 cmH2OSleeve seams: 110.67± 3.84cmH2OBelt attachments: 104 ± 5.19cmH2OBody/sleeve/belt mean: 108 ±3.1 cm H2O	Similar6
Liquid barrierperformance:Impact PenetrationAATCC 42	Pass,Met the standard's requirement. (≤1.0 g)	Chest: <0.1 gSleeve seams: <0.1 gBelt attachments: < 0.1 gBody/sleeve/belt mean: <0.1 g	Same
Breaking strength(MD)ASTM D5034	15.8 ± 3.7 lbf	18.17 ± 0.31 lbf	Similar7
Breaking strength(CD)ASTM D5034	12.25 ± 1.95 lbf	11.78 ± 0.33 lbf	Similar8
Tearing strength(MD)ASTM D5587-08	6.3 ± 1.7 lbf	11.01 ± 0.64 lbf	Similar9
Tearing strength(CD)ASTM D5587	3.6 ± 0.8 lbf	5.30 ± 0.35 lbf	Similar10
Biocompatibility	Under the test conditions, thesubject device was shown to benoncytotoxic, non-irritating andnon-sensitizing per ISO 10993-5,ISO 10993-10, and ISO 10993-23.	Under the test conditions, thesubject device was shown tobe noncytotoxic, non-irritating and non-sensitizingper ISO 10993-5 & ISO10993-10.	Same
Flammability 16CFR Part 1610.7	Meets requirements of FlameResistant CPSC 16 CFR 1610 Class 1	Meets requirements of FlameResistant CPSC 16 CFR 1610Class 1	Same
resistance to permeation of various chemotherapy drugs.
Elements ofComparison	Proposed Device:Copioumed ChemotherapyIsolation GownK230135	Reference Device:CoverU Disposable Gown withTape - Chemo GownK210414	Comparisons
Product Code	FYC, QSO	FYC, QSO	Same
IntendedUse/Indicationsfor Use	Copioumed ChemotherapyIsolation Gown is intended to beworn by healthcare personnel toprotect health care patients andhealth care personnel from thetransfer of microorganisms, bodyfluids and particulate. CopioumedChemotherapy Isolation Gown isnon- sterile and for single useonly.Copioumed ChemotherapyIsolation Gown meets therequirements of an AAMI Level3 barrier protection for anisolation gown per ANSI/AAMIPB70:2012 Liquid BarrierPerformance Classification ofProtective Apparel DrapesIntended for Use in Health CareFacilities (ANSI/AAMI PB70).	CoverU Disposable Gown withTape- Chemo Gown (Modelnumber: IL-4036YKTP-CM) isintended to provide barrierprotection and protect healthcarepersonnel and patients from thetransfer of microorganisms,body fluids and particulatematerial. CoverU DisposableGown with Tape meets therequirements of AAMI Level 4barrier protection for a surgicalisolation gown per ANSI/AAMI PB70:2012 Liquidbarrier performance andclassification of protectiveapparel and drapes intended foruse in health care facilities. Notintended for use in the operatingroom. CoverU DisposableGown with Tapes is a singleuse, disposable medical deviceprovided non-sterile. The gowns	Similar11:1. Referencedevice is onlychosen todemonstratethe evaluatedfor resistanceto permeationof variouschemotherapydrugs
Copioumed ChemotherapyIsolation Gown is a disposabledevice intended to protect healthcare personal fromexposure to chemotherapy drugsduring preparation, handling, andadministration.The Copioumed ChemotherapyIsolation Gown has beenevaluated for resistance topermeation of variouschemotherapy drugs per ASTMF739-20 "Standard Test Methodfor Permeation of Liquids andGases Through ProtectiveClothing Materials UnderConditions of ContinuousContact."Chemotherapydrug permeation resistance,average standardizedbreakthrough time in minutes.*:Carmustine [3.3 mg/ml] >480Cisplatin [1.0 mg/ml] >480Cyclophosphamide [20 mg/ml]>480Cytarabine Hydrochloride [100mg/ml]>480Dacarbazine [10 mg/ml] >480Daunorubicin Hydrochloride [5mg/ml]>480Doxorubicin Hydrochloride [2mg/ml] >480Etoposide [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] >480	have been evaluated forresistance to permeation ofvarious chemotherapy drugs perASTM F739-12, Standard TestMethod for Permeation ofLiquids and Gases ThroughProtective Clothing MaterialsUnder Conditions of ContinuousContact. Chemotherapy drugpermeation resistance, averagestandardized breakthrough timein minutes :Carmustine [3.3 mg/ml] >480Cisplatin [1.0 mg/ml] >480Cyclophosphamide [20 mg/ml]>480Cytarabine Hydrochloride [100mg/ml] >480Dacarbazine [10 mg/ml] >480Daunorubicin Hydrochloride [5mg/ml] >480Doxorubicin Hydrochloride [2mg/ml] > 480Etopside [20 mg/ml] >480Fluorouracil [50 mg/ml] >480lfosfamide [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]>480Docetaxel [10mg/ml] >480Oxaliplatin [5mg/ml] >480Leucovorin [1 0mg/ml] >480No permeation was detected ateither the minimum detectablepermeation or 0.1 g/cm2/min
	Vincristine Sulfate [1 mg/ml]>480
	*No permeation was detected ateither the minimum detectablepermeation or 0.1 µg/cm2/min
MaterialComposition	Polypropylene Gown laminatedwith polyethylene	Spunbonded Polypropylenecoated with Polyethylene(PPSB Coated PE materials)	Different2
Design Features	Knit cuff in three style(model)Tie neck closure, Velcro neckclosure and Sticker neck closure	Close-back	Similar12
Sterility	Non-sterile	Non-sterile	Same
Color	Blue	Yellow	Different3
Use	OTC	OTC	Same
Disposable	Disposable	Disposable	Same
SingleUse/Reusable	Single Use	Single Use	Same
Performance perAAMI PB70:2012	AAMI Level 3	AAMI Level 4	Different4
Resistance topermeation ofchemotherapydrugs testing	ASTM F739-20	ASTM F739-12	Similar13
	Results showed no averageStandardized breakthrough for upto 480 minutes for claimed 16drugs.Chemotherapydrug permeation resistance,average standardizedbreakthrough time in minutes.:Carmustine [3.3 mg/ml] >480Cisplatin [1.0 mg/ml] >480Cyclophosphamide [20 mg/ml]>480Cytarabine Hydrochloride [100mg/ml]>480Dacarbazine [10 mg/ml] >480Daunorubicin Hydrochloride [5mg/ml]>480Doxorubicin Hydrochloride [2mg/ml] >480Etoposide [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]>480No permeation was detected ateither the minimum detectablepermeation or 0.1 µg/cm2/min	Results showed no averagestandardized breakthrough forup to 480 minutes for claimed19 drugsChemotherapy drug permeationresistance, average standardizedbreakthrough time in minutes :Carmustine [3.3 mg/ml] >480Cisplatin [1.0 mg/ml] >480Cyclophosphamide [20 mg/ml]>480Cytarabine Hydrochloride [100mg/ml] >480Dacarbazine [10 mg/ml] >480Daunorubicin Hydrochloride [5mg/ml] >480Doxorubicin Hydrochloride [2mg/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]>480Docetaxel [10mg/ml] >480Oxaliplatin [5mg/ml] >480Leucovorin [1 0mg/ml] >480No permeation was detected ateither the minimum detectablepermeation or 0.1 g/cm2/min

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Similarity': The proposed device and predicate device have the same isolation protection. The proposed device also emphasizes on the protection of chemotherapy drugs. This difference does not affect the safety and efficacy of the proposed gown.

Similarity-2: Even though the description of materials for proposed device are slightly different, it shall be the same materials. Therefore, this difference does not raise any concerns on safety and efficacy.

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Similarity3 The predicate device has more various designs on gowns and the main different designs of proposed device are on the neck. The design of the gown has been evaluated in different tests which does not raise any concerns about safety and efficacy.

Similarity5: Theses gowns were tested using the ASTM D3776 standard testing methods. As there were no limit or criteria for this test, the test values of proposed device passed the criteria set by Copioumed International INC. The bigger values of testing results do not raise extra concerns of safety and efficacy.

Similarity. The testing targets of proposed device have covered the testing targets of predicate device. The proposed device also tested the armpit and shoulder seam. All the testing results of proposed device met the criteria of standard.

Similarity 3. The proposed device and predicate device were tested for "breaking strength" using ASTM D5034. The breaking strength of the proposed device differed from the predicate device but were within the acceptance criteria. Therefore, the difference does not raise any questions on the safety and effectiveness of the proposed device. Similarity 300. The proposed device and predicate device were tested for "breaking strength" using ASTM D5587. The breaking strength of the proposed device differed from the predicate device but were within the acceptance criteria. Different : The predicate device does not test the resistance to permeation of various chemotherapy drugs.

K. COMPARISON TO REFERENCE DEVICE

In order to compare with the legal marketed Chemo gown, another cleared device, K210414, CoverU Disposable Gown with Tape - Chemo Gown, was selected for reference to demonstrate the evaluated for

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Similar ! The reference device is only chosen to demonstrate the evaluated for resistance to permeation of various chemotherapy drugs. Both proposed device and reference device were tested for resistance to permeation of various chemotherapy drugs per the Consensus Standard ASTM F739-20, Test Method for Permeation of Liquids and Gases Through Protective Clothing Materials Under Conditions of Continuous Contact. The reference device was tested for three more drugs than the subject device. The tested drugs are listed clearly in labeling with the proposed device.

Similar12: The reference device has similar designs, offering protective backs.

Different23: The proposed device and reference device utilize different textiles and are different colors. Both meet their respective performance test requirements.

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Different4: Even the proposed device and reference device are different level of protection, the main reason to choose the reference device is to demonstrate the evaluated for resistance to permeation of various chemotherapy drugs.

The reference device, a chemo gown meeting AAMI PB70 Level 4 barrier performance, relies upon ASTM F739-12 to demonstrate its resistance to listed chemotherapy drug permeation. ASTM F739-20, the version of the standard currently recognized, is used to demonstrate the barrier performance for tested chemotherapy drugs in the subject AAMI PB70 Level 3 chemotherapy isolation gown.

No.	Standards	Purpose	Criteria	Results
1.	AATCC 42	To demonstrate resistance to penetration of sprayed water	≤1.0 g	Pass
2.	AATCC 127	To demonstrate resistance to penetration of pressurized water	≥50 cm H2O	Pass
3.	ANSI/AAMIPB70:2012AAMI Level 3	To demonstrate adequate liquid barrier performance	Level 3	Pass
4.	ASTM F739-20	To demonstrate resistance to penetration of chemotherapy drugs	≥480 minutes	Pass
5.	ASTMD3776/D3776M-17	To determine the mass of the fabric	Informative	Pass
6.	ASTM D5034 - 92017	To demonstrate adequate tensile strength of the material	≥30 N	Pass
7.	ASTM 1683-17(2018)	To demonstrate adequate seam strength	≥30 N	Pass
8.	ASTM D5587-15(2019)	To demonstrate adequate tear strength of the material	≥10 N	Pass
9.	NWSP 160.1	To determine the linting properties	Informative	Pass
10.	ISO 9073-10:2003	To determine linting properties	Informative	Pass
11.	16 CFR 1610	Standard for the Flammability forClothing Textiles	Class 1	Pass
12.	ISO 10993-5:2009	To assess the potential cytotoxicity of the gown	Under the conditions ofthe testing, non-cytotoxic	Pass
13	ISO 10993-10:2021	To assess the sensitization potential of the gown	Under the conditions ofthe testing, not asensitizer	Pass
14	ISO 10993-23:2021	To assess the irritation potential of the gown	Under the conditions ofthe testing, not an irritant	Pass

L. SUMMARY OF NON-CLINICAL TESTING

M. SUMMARY OF CLINICAL TESTING

No clinical testing was performed in support of this 510(k)

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N. CONCLUSION

The conclusions drawn from the non-clinical testing demonstrate that the subject device, Copioumed Chemotherapy Isolation Gown, is as safe, as effective, and performs as well as or better than the legally marketed predicate device K190306.

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.

Bifeng Qian -S

Indications for Use

Indications for Use (Describe)

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510(k) SUMMARY

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J. COMPARISON OF CHARACTERISTICS WITH THE PREDICATE DEVICE

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L. SUMMARY OF NON-CLINICAL TESTING

M. SUMMARY OF CLINICAL TESTING

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N. CONCLUSION

§ 878.4040 Surgical apparel.

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