The Medline Orbis Chemo Surgical Gown is intended to be worn by operating room personnel during surgical procedures to protect operating room personnel from transfer of microorganisms, body fluids, and particulate material. Additionally the gown is intended to protect healthcare personnel from exposure to chemotherapy drugs during their preparation, handling, and administration. Non-sterile gowns are to be sold in bulk to re-packager/re-labeler establishments for ethylene oxide (EtO) sterilization according to ISO 11135-1 prior to marketing to the end users and Sterile surgical gowns are to be sold directly to users after EtO sterilization validation to ISO 11135-1.

The Medline Orbis Chemo Surgical Gown meets the level 3 barrier protection requirements in accordance with ANSI/AAMI Standard PB70:2012 "Liquid Barrier Performance and Classification of Protective Apparel and Drapes intended for use in Health Care Facilities"

The Medline Orbis Chemo Surgical gown has 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."

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

Gown selection should be specifically chosen for the type of chemotherapy agent used. Users are recommended to review Material Safety Data Sheets for Chemotherapy Drugs being used to determine the required level of protection.

Device Description

The Medline Orbis Chemo Surgical Gown is a single-use, disposable, level 3 surgical gown available in sterile and non-sterile configurations. The multiple configurations and sizes are described in Table 1 below. The Medline Orbis Chemo Surgical Gown is manufactured using a nonwoven polypropylene spunbond. Each gown is designed with a hook and loop closure at the neck, four ties at the waist, knitted polyester cuffs at the end of the sleeves as well as a transfer tab for ease in donning.

AI/ML Overview

The document describes the acceptance criteria and the performance studies for the Medline Orbis Chemo Surgical Gown. Since this is a physical medical device (surgical gown), the studies are non-clinical (laboratory testing) rather than clinical studies involving human or AI readers. Therefore, several of the requested categories (e.g., sample size for test set, number of experts, adjudication method, MRMC study, standalone performance, training set size) are not applicable in the context of this device.

Here's a breakdown of the requested information based on the provided text:

Acceptance Criteria and Device Performance

Standard	Name	Acceptance Criteria	Reported Device Performance
ISO 10993-5	ISO MEM Elution Using L-929 Mouse Fibroblast Cells	Cytotoxicity	Pass
ISO 10993-10	ISO Intracutaneous Irritation Test	Irritation and Sensitization	Pass
AATCC 42-17	Water Resistance	Water Resistance	Pass
AATCC 127-18	Hydrostatic Pressure	Water Resistance	Pass
ASTM D5034-09	Breaking Strength and Elongation of Textile Fabrics (Grab Test)	Tensile Strength	Pass
ASTM D5587-15	Tearing Strength of Fabrics by Trapezoid Procedure	Trapezoid Tear	Pass
ASTM D3776/D3776M-09a	Basis Weight-Mass Per Unit Area (Weight) of Fabric	Material Weight	Pass
ASTM D3786/D3786M-13	Bursting Strength of Textile Fabrics-Diaphragm Bursting Strength Tester Method	Burst Strength	Pass
ASTM D1683-17	Standard Test Method for Failure in Sewn Seams of Woven Apparel Fabrics	Seam Strength	Pass
16 CFR 1610	Flammability of Clothing Textiles	Flammability	Pass
ANSI/AAMI/ISO 10993-7: 2008(R)2012	Biological evaluation of medical devices –Part 7: Ethylene oxide sterilization residuals	EO and ECH Residuals	Pass
ANSI AAMI PB70:2012	Liquid Barrier and Performance Classification of Protective Apparel and Surgical Drapes Intended for Use in Healthcare Facilities	Fluid Resistance (AAMI Level 3)	Pass (Meets Level 3)
ASTM F739-12	Permeation of Liquids and Gases Through Protective Clothing	Chemical Penetration (various chemotherapy drugs, >480 minutes breakthrough time)	Pass (>480 minutes without breakthrough)
ISO 9073-10-2004	Test methods for nonwovens Lint and other particles generation in the dry state	Particulate	Pass

Specific Chemotherapy Drug Permeation Results (ASTM F739-12):
For the following chemotherapy drugs, the device showed no average standardized breakthrough for up to 480 minutes:

Carmustine [3.3 mg/ml]
Cisplatin [1.0 mg/ml]
Cyclophosphamide [20 mg/ml]
Cytarabine Hydrochloride [100 mg/ml]
Dacarbazine [10 mg/ml]
Daunorubicin Hydrochloride [5 mg/ml]
Doxorubicin Hydrochloride [2 mg/ml]
Etopside [20 mg/m1]
Fluorouracil [50 mg/ml]
Ifosfamide [50 mg/ml]
Methotrexate [25 mg/ml]
Mitomycin C [0.5 mg/ml]
Mitoxantrone [2.0 mg/ml]
Paclitaxel [6 mg/m]]
Thiotepa [10 mg/ml]
Vincristine Sulfate [1 mg/m]]

Additional Requested Information:

Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Sample Size: Not explicitly stated in terms of number of gowns, but standard testing for such products involves a specific number of samples as dictated by each ASTM/ISO/AATCC standard. The tests are laboratory-based, not based on a "test set" of patient data.
- Data Provenance: Not specified, but generally, such non-clinical tests are performed in certified laboratories, likely within the manufacturer's operational region or by contract testing facilities. The tests are prospective in nature, as they are performed specifically to evaluate the device.
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):
- Not Applicable. This is a non-clinical device that relies on standardized laboratory test methods for performance evaluation, not expert-derived ground truth from human observations or medical imaging.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not Applicable. The performance is determined by objective laboratory measurements against defined acceptance criteria, not through expert adjudication.
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:
- Not Applicable. This is a physical medical device (surgical gown), not an AI-powered diagnostic or assistive tool for human readers.
If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Not Applicable. This is a physical medical device, not an algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- Objective Test Standards and Criteria: The "ground truth" for this device's performance is established by the specific, objective measurement methods and acceptance criteria defined within internationally recognized standards (e.g., ISO, ASTM, AATCC, ANSI/AAMI). For example, "Pass" for cytotoxicity per ISO 10993-5 means the material did not exhibit cytotoxic effects according to that standard's defined procedure.
The sample size for the training set:
- Not Applicable. This is a physical device, and there is no "training set" in the context of machine learning or AI.
How the ground truth for the training set was established:
- Not Applicable. As there is no training set for a physical device, this question is irrelevant.

Summary

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food & Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

May 6, 2022

Medline Industries LP Adam Ostrower Sr. Specialist RA Three Lakes Drive Northfield, Illinois 60093

Re: K214108

Trade/Device Name: Medline Orbis Chemo Surgical Gown Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical Apparel Regulatory Class: Class II Product Code: FYA, QSO Dated: April 13, 2022 Received: April 13, 2022

Dear Adam Ostrower:

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 statutes and regulations administered by other Federal agencies. You must comply with all the Act's

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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 (OS) 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 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).

Sincerely,

Clarence W. Murray, III, PhD 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) K214108

Device Name Medline Orbis Chemo Surgical Gown

Indications for Use (Describe)

The Medline Orbis Chemo Surgical Gown meets the level 3 barrier protection requirements in accordance with ANSU A AMI Standard PB 70:2012 "Liquid Barrier Performance and Classification of Protective Apparel and Drapes intended for use in Health Care Facilities"

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/m1] >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/m]] >480 Thiotepa [10 mg/ml] >480 Vincristine Sulfate [1 mg/m]] >480

Type of Use (Select one or both, as applicable)
-------------------------------------------------

Prescription Use (Part 21 CFR 801 Subpart D)

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

CONTINUE ON A SEPARATE PAGE IF NEEDED.

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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:

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Image /page/4/Picture/0 description: The image shows the logo for Medline, a healthcare company. The logo features the word "MEDLINE" in white, bold sans-serif font. Above the word is a white star-like symbol with four points, resembling a compass rose. The background is a solid dark blue color, providing a strong contrast to the white text and symbol.

510(k) SUMMARY - K214108 [AS REQUIRED BY 21CFR807.92(c)]

Submitter / 510(k) Sponsor

Medline Industries, LP. Three Lakes Drive Northfield, IL 60093

Registration Number: 1417592

Contact Person

Adam Ostrower Regulatory Affairs Sr. Specialist Phone: 224-931-1513 Email: aostrower@medline.com

Summary Preparation Date

December 27th, 2021

Type of 510(k) Submission Traditional

Device Name / Classification

Trade Name: Medline Orbis Chemo Surgical Gown Common Name: Surgical Gown Classification Name: Surgical Gown Product Code: FYA, QSO Classification Panel: General Hospital Regulatory Class: II Regulation Number: 21 CFR 878.4040

Predicate Device

Cardinal Health ChemoPlus Full Coverage Gown, Closed Back, Cardinal Health ChemoPlus Full Coverage Gown, Open Back K193327

Device Description

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Image /page/5/Picture/0 description: The image shows the Medline logo. The logo is white text on a blue background. The text "MEDLINE" is in bold, sans-serif font and is stacked on top of a white starburst symbol.

Catalog #	Description	Sterile orNon-Sterile
DYNJP2015C	Orbis Chemo Surgical Gown, Breathable Film Gown, Small	Sterile
DYNJP2011C	Orbis Chemo Surgical Gown, Breathable Film Gown, Large	Sterile
DYNJP2012C	Orbis Chemo Surgical Gown, Breathable Film Gown, X-Large	Sterile
DYNJP2013C	Orbis Chemo Surgical Gown, Breathable Film Gown, XX-Large	Sterile
DYNJP2014C	Orbis Chemo Surgical Gown, Breathable Film Gown, XXX-Large	Sterile
DYNJP2019C	Orbis Chemo Surgical Gown, Breathable Film Gown, XXXX-Large	Sterile
DYNJP2012CL	Orbis Chemo Surgical Gown, Breathable Film Gown, X-Large, X-Long	Sterile
DYNJP2013CL	Orbis Chemo Surgical Gown, Breathable Film Gown, XX-Large,X-Long	Sterile
SPT-2015C	Orbis Chemo Surgical Gown, Breathable Film Gown, Small	Non-Sterile
SPT-2011C	Orbis Chemo Surgical Gown, Breathable Film Gown, Large	Non-Sterile
SPT-2012C	Orbis Chemo Surgical Gown, Breathable Film Gown, X-Large	Non-Sterile
SPT-2013C	Orbis Chemo Surgical Gown, Breathable Film Gown, XX-Large	Non-Sterile
SPT-2014C	Orbis Chemo Surgical Gown, Breathable Film Gown, XXX-Large	Non-Sterile
SPT-2012CL	Orbis Chemo Surgical Gown, Breathable Film Gown, X-Large, X-Long	Non-Sterile
SPT-2013CL	Orbis Chemo Surgical Gown, Breathable Film Gown, XX-Large, X-Long	Non-Sterile

Table 1: Medline Orbis Chemo Surgical Gown configurations

Note: SPT, non-sterile gowns will be offered as part of a separate kit

Indications for Use

Carmustine [3.3 mg/ml] >480 Cisplatin [1.0 mg/ml] >480

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Image /page/6/Picture/0 description: The image features the logo for Medline, a company specializing in medical supplies and solutions. The logo consists of the word "MEDLINE" in bold, sans-serif font, positioned to the left of a stylized starburst symbol. The starburst is white, while the word "MEDLINE" is in a darker color, possibly black or a dark shade of blue. The background is a solid, lighter shade of blue, providing contrast and making the logo elements stand out.

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

Summary of Technological Characteristics

Device Characteristic	Proposed Device	Predicate Device	ComparisonAnalysis
Product Name	Medline Orbis ChemoSurgical Gown	Cardinal Health ChemoPlusFull Coverage Gown, ClosedBack, Cardinal HealthChemoPlus Full CoverageGown, Open Back	Different
510(k) Reference	N/A	K193327	Different
Product Owner	Medline Industries Inc.	Cardinal Health 200, LLC	Different
Product Code	FYA, QSO	FYA	Same
Intended Use	The Medline Orbis ChemoSurgical Gown is intendedto be worn by operatingroom personnel duringsurgical procedures toprotect operating roompersonnel from transfer ofmicroorganisms, bodyfluids, and particulatematerial. Additionally thegown is intended toprotect healthcarepersonnel from exposureto chemotherapy drugsduring their preparation	The Cardinal Health™ChemoPlus™ FullCoverage Gowns, OpenBack, are intendedto protect healthcarepersonnel from exposure tochemotherapy drugs duringpreparation, handling, andadministration. The openback gowns are single use,disposable medical devicesprovided nonsterile. Theopen back gown isnonprotective in the back.The open back gowns are not	Similar

	handling, andadministration. Non-sterile gowns are to besold in bulk to re-packager/re-labelerestablishments forethylene oxide (EtO)sterilization accordingto ISO 11135-1 priorto marketing to theend users and Sterilesurgical gowns are tobe sold directly tousers after EtOsterilization validationto ISO 11135-1.The Medline Orbis ChemoSurgical Gown meets thelevel 3 barrier protectionrequirements inaccordance withANSI/AAMI StandardPB70:2012 "LiquidBarrier Performance andClassification ofProtective Apparel andDrapes intended for use inHealth Care Facilities"The Medline Orbis ChemoSurgical gown has beenevaluated for resistance topermeation of variouschemotherapy drugs perASTM F739-12 "StandardTest Method forPermeation of Liquids andGases Through ProtectiveClothing Materials UnderConditions of ContinuousContact."	intended for use in theoperating room.
Regulation Number	21 CFR 878.4040	21 CFR 878.4040	Same
Color	Light Blue	Blue	Similar
Design Features	Polyester Knit CuffHook and Loop NeckClosureWaist TiesUltrasonic Sealed Seams	Polyester Knit cuffHook and Loop NeckClosureBelt Ties integrated in theback of gownTaped seams	Similar
Sizes	Small-XXXX-Large	Medium to XX-Large	Different
Materials	Nonwoven polypropylenespunbond fabric	Nonwoven polypropylenespunbond fabricwith a polyethylene laminatecoating (alsoreferred to as laminate)	Similar
Prescription vs. OTC	OTC	OTC	Same
Contact Durations	Surface, Intact, < 24 hours	Surface, Intact, < 24 hours	Same

Table 2: Comparison of Proposed and Predicate Devices

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Image /page/8/Picture/0 description: The image shows the logo for Medline. The logo consists of the word "MEDLINE" in a bold, sans-serif font, with the letters stacked on top of each other. To the right of the word is a white, stylized starburst symbol. The background of the logo is a solid dark blue color.

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Image /page/9/Picture/0 description: The image shows the Medline logo. The logo consists of the word "MEDLINE" in a bold, sans-serif font, with the letters slightly slanted to the right. Above the word is a white star-like symbol with four points. The background of the logo is a solid dark blue color.

Sterile vs. Non-Sterile	Sterile and Non-Sterile	Sterile and Non-Sterile	Same
Disposable vs. Non-Disposable	Disposable	Disposable	Same
Single Use vs. Reusable	Single Use	Single Use	Same
Performance per AAMIPB70:2012	AAMI Level 3	AAMI Level 3	Same
Evaluation per ASTMF739-12	Carmustine, Cisplatin,Cyclophosphamide,Cytarabine,Dacarbazine,Daunorubicin,DoxorubicinHydrochloride, Etoposide,Fluorouracil, Ifosfamide,Methotrexate,Mitomycin C,Mitoxantrone, Paclitaxel,Thiotepa, VincristineSulfate. Resultsshowed no averagestandardizedbreakthrough for up to 480minutes.	Carmustine, Cisplatin,Cyclophosphamide,Cytarabine,Dacarbazine, Daunorubicin,Doxorubicin Hydrochloride,Etoposide,Fluorouracil, Ifosfamide,Methotrexate,Mitomycin C, Mitoxantrone,Paclitaxel.Thiotepa, VincristineSulfate. Resultsshowed no averagestandardizedbreakthrough for up to 480minutes.	Same
Biocompatibility	Under the test conditions,the subject device wasshown to be non-cytotoxic, non-irritatingand non-sensitizing perISO 10993-5 & ISO10993-10.	Under the test conditions, thesubject device was shown tobe non-cytotoxic, non-irritating and non-sensitizingper ISO 10993-5 & ISO10993-10.	Same
Flammability	Meets requirements ofFlame Resistant CPSC 16CFR 1610 Class 1	Meets requirements of FlameResistant CPSC 16 CFR1610 Class 1	Same
Sterilization Method	Ethylene Oxide (EtO)	Ethylene Oxide (EtO)	Same

Summary of Non-Clinical Testing

Non-clinical performance testing was completed on the Medline Orbis Chemo Surgical Gown to demonstrate the subject device is in accordance with the relevant test methods described in Table 3 below.

Table 3: Summary of Non-Clinical Testing and Standards Applied

Standard	Name	Acceptance Criteria	Result
ISO 10993-5	ISO MEM Elution Using L-929 Mouse FibroblastCells	Cytotoxicity	Pass
ISO 10993-10	ISO Intracutaneous Irritation Test	Irritation andSensitization	Pass
AATCC 42-17	Water Resistance	Water Resistance	Pass

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Image /page/10/Picture/0 description: The image shows the word "MEDLINE" in white font on a blue background. The word is positioned to the left of a white starburst symbol. The starburst symbol has four points, one pointing up, one pointing down, and one pointing to each side.

AATCC 127-18	Hydrostatic Pressure	Water Resistance	Pass
ASTM D5034-09	Breaking Strength and Elongation of Textile Fabrics(Grab Test)	Tensile Strength	Pass
ASTM D5587-15	Tearing Strength of Fabrics by Trapezoid Procedure	Trapezoid Tear	Pass
ASTM D3776/D3776M-09a	Basis Weight-Mass Per Unit Area (Weight) of Fabric	Material Weight	Pass
ASTM D3786/D3786M-13	Bursting Strength of Textile Fabrics-DiaphragmBursting Strength Tester Method	Burst Strength	Pass
ASTM D1683-17	Standard Test Method for Failure in Sewn Seamsof Woven Apparel Fabrics	Seam Strength	Pass
16 CFR 1610	Flammability of Clothing Textiles	Flammability	Pass
ANSI/AAMI/ISO 10993-7:2008(R)2012	Biological evaluation of medical devices –Part 7:Ethylene oxide sterilization residuals	EO and ECH Residuals	Pass
ANSI AAMI PB70:2012	Liquid Barrier and Performance Classification ofProtective Apparel and Surgical Drapes Intended forUse in Healthcare Facilities	Fluid Resistance	Pass
ASTM F739-12	Permeation of Liquids and Gasses ThroughProtective Clothing	Chemical Penetration,under continuous contact	Pass
ISO 9073-10-2004	Test methods for nonwovens Lint and other particlesgeneration in the dry state	Particulate	Pass

Summary of Clinical Testing

Not applicable.

Conclusion

The conclusions drawn from the nonclinical test demonstrate that the device, Medline Orbis Chemo Surgical Gown, is as safe, as effective and perform as well or better than the legally marketed predicate device, Cardinal Health ChemoPlus Full Coverage Gown, Closed Back, Cardinal Health ChemoPlus Full Coverage Gown, Open Back, K193327.

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.