Medline Orbis Chemo Surgical Gown
Device Facts
| Record ID | K214108 |
|---|---|
| Device Name | Medline Orbis Chemo Surgical Gown |
| Applicant | Medline Industries, LP |
| Product Code | FYA · General, Plastic Surgery |
| Decision Date | May 6, 2022 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 878.4040 |
| Device Class | Class 2 |
Indications for Use
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 to ISO 11135-1.
Device Story
Single-use, disposable, level 3 surgical gown; manufactured from nonwoven polypropylene spunbond fabric. Features include hook and loop neck closure, waist ties, knitted polyester cuffs, and ultrasonic sealed seams. Protects operating room personnel from microorganisms, body fluids, and particulates; protects healthcare personnel from chemotherapy drug exposure. Available in sterile and non-sterile configurations. Non-sterile versions require EtO sterilization per ISO 11135-1 before end-user distribution. Gown selection based on specific chemotherapy agent and required protection level per Material Safety Data Sheets.
Clinical Evidence
No clinical data. Bench testing only. Performance demonstrated via AAMI PB70:2012 (liquid barrier), ASTM F739-12 (chemotherapy permeation), ISO 10993-5/10 (biocompatibility), and various textile strength/flammability standards.
Technological Characteristics
Nonwoven polypropylene spunbond fabric; AAMI Level 3 barrier protection; ultrasonic sealed seams; polyester knit cuffs; hook and loop neck closure; ethylene oxide (EtO) sterilization per ISO 11135-1; biocompatibility per ISO 10993-5/10; flammability per 16 CFR 1610 Class 1.
Indications for Use
Indicated for operating room personnel during surgical procedures to protect against microorganisms, body fluids, and particulates; also indicated for healthcare personnel handling, preparing, or administering chemotherapy drugs.
Regulatory Classification
Identification
Surgical apparel are devices that are intended to be worn by operating room personnel during surgical procedures to protect both the surgical patient and the operating room personnel from transfer of microorganisms, body fluids, and particulate material. Examples include surgical caps, hoods, masks, gowns, operating room shoes and shoe covers, and isolation masks and gowns. Surgical suits and dresses, commonly known as scrub suits, are excluded.
Special Controls
*Classification.* (1) Class II (special controls) for surgical gowns and surgical masks. A surgical N95 respirator or N95 filtering facepiece respirator is not exempt if it is intended to prevent specific diseases or infections, or it is labeled or otherwise represented as filtering surgical smoke or plumes, filtering specific amounts of viruses or bacteria, reducing the amount of and/or killing viruses, bacteria, or fungi, or affecting allergenicity, or it contains coating technologies unrelated to filtration (e.g., to reduce and or kill microorganisms). Surgical N95 respirators and N95 filtering facepiece respirators are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 878.9, and the following conditions for exemption:(i) The user contacting components of the device must be demonstrated to be biocompatible. (ii) Analysis and nonclinical testing must: (A) Characterize flammability and be demonstrated to be appropriate for the intended environment of use; and (B) Demonstrate the ability of the device to resist penetration by fluids, such as blood and body fluids, at a velocity consistent with the intended use of the device. (iii) NIOSH approved under its regulation. (2) Class I (general controls) for surgical apparel other than surgical gowns and surgical masks. The class I device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 878.9.
Predicate Devices
- Cardinal Health ChemoPlus Full Coverage Gown, Closed Back, Cardinal Health ChemoPlus Full Coverage Gown, Open Back (K193327)
Submission Summary (Full Text)
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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 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 to ISO 11135-1.
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"
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/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
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.
| 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)
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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
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.
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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 or<br>Non-<br>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-<br>Large | Sterile |
| DYNJP2012CL | Orbis Chemo Surgical Gown, Breathable Film Gown, X-Large, X-<br>Long | Sterile |
| DYNJP2013CL | Orbis Chemo Surgical Gown, Breathable Film Gown, XX-Large,<br>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-<br>Long | Non-Sterile |
| SPT-2013CL | Orbis Chemo Surgical Gown, Breathable Film Gown, XX-Large, X-<br>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
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
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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
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.
## Summary of Technological Characteristics
| Device Characteristic | Proposed Device | Predicate Device | Comparison<br>Analysis |
|-----------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------|
| Product Name | Medline Orbis Chemo<br>Surgical Gown | Cardinal Health ChemoPlus<br>Full Coverage Gown, Closed<br>Back, Cardinal Health<br>ChemoPlus Full Coverage<br>Gown, 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 Chemo<br>Surgical Gown is intended<br>to be worn by operating<br>room personnel during<br>surgical procedures to<br>protect operating room<br>personnel from transfer of<br>microorganisms, body<br>fluids, and particulate<br>material. Additionally the<br>gown is intended to<br>protect healthcare<br>personnel from exposure<br>to chemotherapy drugs<br>during their preparation | The Cardinal Health™<br>ChemoPlus™ Full<br>Coverage Gowns, Open<br>Back, are intended<br>to protect healthcare<br>personnel from exposure to<br>chemotherapy drugs during<br>preparation, handling, and<br>administration. The open<br>back gowns are single use,<br>disposable medical devices<br>provided nonsterile. The<br>open back gown is<br>nonprotective in the back.<br>The open back gowns are not | Similar |
| | | | |
| | handling, and<br>administration. Non-<br>sterile gowns are to be<br>sold in bulk to re-<br>packager/re-labeler<br>establishments for<br>ethylene oxide (EtO)<br>sterilization according<br>to ISO 11135-1 prior<br>to marketing to the<br>end users and Sterile<br>surgical gowns are to<br>be sold directly to<br>users after EtO<br>sterilization validation<br>to ISO 11135-1.<br>The Medline Orbis Chemo<br>Surgical Gown meets the<br>level 3 barrier protection<br>requirements in<br>accordance with<br>ANSI/AAMI Standard<br>PB70:2012 "Liquid<br>Barrier Performance and<br>Classification of<br>Protective Apparel and<br>Drapes intended for use in<br>Health Care Facilities"<br>The Medline Orbis Chemo<br>Surgical gown has been<br>evaluated for resistance to<br>permeation of various<br>chemotherapy drugs per<br>ASTM F739-12 "Standard<br>Test Method for<br>Permeation of Liquids and<br>Gases Through Protective<br>Clothing Materials Under<br>Conditions of Continuous<br>Contact." | intended for use in the<br>operating room. | |
| Regulation Number | 21 CFR 878.4040 | 21 CFR 878.4040 | Same |
| Color | Light Blue | Blue | Similar |
| Design Features | Polyester Knit Cuff<br>Hook and Loop Neck<br>Closure<br>Waist Ties<br>Ultrasonic Sealed Seams | Polyester Knit cuff<br>Hook and Loop Neck<br>Closure<br>Belt Ties integrated in the<br>back of gown<br>Taped seams | Similar |
| Sizes | Small-XXXX-Large | Medium to XX-Large | Different |
| Materials | Nonwoven polypropylene<br>spunbond fabric | Nonwoven polypropylene<br>spunbond fabric<br>with a polyethylene laminate<br>coating (also<br>referred 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-<br>Disposable | Disposable | Disposable | Same |
| Single Use vs. Reusable | Single Use | Single Use | Same |
| Performance per AAMI<br>PB70:2012 | AAMI Level 3 | AAMI Level 3 | Same |
| Evaluation per ASTM<br>F739-12 | Carmustine, Cisplatin,<br>Cyclophosphamide,<br>Cytarabine,<br>Dacarbazine,<br>Daunorubicin,<br>Doxorubicin<br>Hydrochloride, Etoposide,<br>Fluorouracil, Ifosfamide,<br>Methotrexate,<br>Mitomycin C,<br>Mitoxantrone, Paclitaxel,<br>Thiotepa, Vincristine<br>Sulfate. Results<br>showed no average<br>standardized<br>breakthrough for up to 480<br>minutes. | Carmustine, Cisplatin,<br>Cyclophosphamide,<br>Cytarabine,<br>Dacarbazine, Daunorubicin,<br>Doxorubicin Hydrochloride,<br>Etoposide,<br>Fluorouracil, Ifosfamide,<br>Methotrexate,<br>Mitomycin C, Mitoxantrone,<br>Paclitaxel.<br>Thiotepa, Vincristine<br>Sulfate. Results<br>showed no average<br>standardized<br>breakthrough for up to 480<br>minutes. | Same |
| Biocompatibility | Under the test conditions,<br>the subject device was<br>shown to be non-<br>cytotoxic, non-irritating<br>and non-sensitizing per<br>ISO 10993-5 & ISO<br>10993-10. | Under the test conditions, the<br>subject device was shown to<br>be non-cytotoxic, non-<br>irritating and non-sensitizing<br>per ISO 10993-5 & ISO<br>10993-10. | Same |
| Flammability | Meets requirements of<br>Flame Resistant CPSC 16<br>CFR 1610 Class 1 | Meets requirements of Flame<br>Resistant CPSC 16 CFR<br>1610 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 Fibroblast<br>Cells | Cytotoxicity | Pass |
| ISO 10993-10 | ISO Intracutaneous Irritation Test | Irritation and<br>Sensitization | 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<br>(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<br>Bursting Strength Tester Method | Burst Strength | Pass |
| ASTM D1683-17 | Standard Test Method for Failure in Sewn Seams<br>of Woven Apparel Fabrics | Seam Strength | Pass |
| 16 CFR 1610 | Flammability of Clothing Textiles | Flammability | Pass |
| ANSI/AAMI/ISO 10993-7:<br>2008(R)2012 | Biological evaluation of medical devices –Part 7:<br>Ethylene oxide sterilization residuals | EO and ECH Residuals | Pass |
| ANSI AAMI PB70:2012 | Liquid Barrier and Performance Classification of<br>Protective Apparel and Surgical Drapes Intended for<br>Use in Healthcare Facilities | Fluid Resistance | Pass |
| ASTM F739-12 | Permeation of Liquids and Gasses Through<br>Protective Clothing | Chemical Penetration,<br>under continuous contact | Pass |
| ISO 9073-10-2004 | Test methods for nonwovens Lint and other particles<br>generation 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.
