(159 days)
No
The device description and intended use clearly define a physical surgical gown with barrier properties, and there is no mention of any software, algorithms, or data processing that would involve AI or ML.
No.
The device is a surgical gown intended to protect healthcare workers and patients from the transfer of microorganisms, body fluids, and particulate matter, not to treat or cure a disease or health condition.
No
Explanation: The device is a surgical gown, which is a protective apparel, not a device used to diagnose medical conditions. Its intended use is to protect from transfer of microorganisms, body fluids, and particulate matter.
No
The device description clearly states it is a physical surgical gown constructed from various materials, not software.
Based on the provided text, the Medline Level 4 Surgical Gown with Breathable Sleeves is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use clearly states the gown is for protecting healthcare professionals and patients from the transfer of microorganisms, body fluids, and particulate matter. This is a barrier function, not a diagnostic function performed in vitro (outside the body).
- Device Description: The description focuses on the materials and construction of the gown, emphasizing its barrier properties and compliance with standards for protective apparel. There is no mention of reagents, assays, or any components used for testing samples from the human body.
- Performance Studies: The performance studies listed are related to the physical properties and barrier performance of the gown (cytotoxicity, irritation, sensitization, liquid barrier tests, etc.). These are not studies related to diagnostic accuracy or the detection of substances in biological samples.
- Lack of IVD Characteristics: The text does not mention any of the typical characteristics of an IVD device, such as:
- Analyzing samples (blood, urine, tissue, etc.)
- Detecting specific analytes (proteins, genes, pathogens, etc.)
- Providing diagnostic information about a patient's health status
In summary, the Medline Level 4 Surgical Gown is a protective medical device designed to prevent the spread of contamination, not to perform diagnostic tests.
N/A
Intended Use / Indications for Use
The Medline Level 4 Surgical Gown with Breathable Sleeves is a sterile, single use surgical apparel intended to be worn by healthcare professionals to help protect both the healtheare worker from the transfer of microorganisms, body fluids, and particulate matter. The Medline Level 4 Surgical Gown with Breathable Sleeves meets the Level 4 requirements of ANSI/AAMIPB70:2022 Liquid barrier performance and classification of protective apparel and drapes intended for use in healthcare facilities.
The Medline Level 4 Surgical Gown with Breathable Sleeves is also sold in a non-sterile version to re-packagers Kitting entities, to be sterilized using the validated ethylene oxide sterilization method according to ISO 11135-1 in its final finished form, as a kit component.
Product codes (comma separated list FDA assigned to the subject device)
FYA
Device Description
The Medline Level 4 Surgical Gown with Breathable Sleeves is a single-use, sterile, disposable medical device that is provided in a variety of sizes (Large, X-Large, 3X-Large, 3X-Large and X-Long (only Sirus)) and styles (Sirus, Aurora and Eclipse). The Medline Level 4 Surgical Gown with Breathable Sleeves is constructed from nonwoven SMS (spunbond, meltblown, spunbond), a poly-fabric reinforcement on the chest front panel, and a breathable film (Polyester ether and polyester) for the sleeves. Each gown is designed with a hook and loop closure at the neck, ties at the waist, knitted cuffs at the end of the sleeves as well as a transfer tab for ease in donning. The Medline Level 4 Surgical Gown with Breathable Sleeves has been tested according to ANSI/AAMI PB70:2022 and meets AAMI Level 4 barrier level protection for a surgical gown.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
healthcare professionals
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-clinical tests were conducted to verify that the proposed device met all design specifications. The subject surgical gown was assessed for performance using the following standards and test methods. The test results demonstrated that the proposed device met its acceptance criteria or testing endpoints.
The tests conducted were ISO 10993-5 Cytotoxicity, ISO 10993-23 Irritation, ISO 10993-10 Sensitization, ASTM F1671 (Resistance of Materials Used in Protective Clothing to Penetration by Blood-Borne Pathogens), AATCC 42 (Water Resistance: Impact Penetration Test), AATCC 127 (Water Resistance: Hydrostatic Pressure Test), ASTM D5034-09 (2013) (Breaking Strength and Elongation of Textile Fabrics (Grab Test)), ASTM D5587-15 (Tearing Strength of Fabrics by Trapezoid Procedure), ASTM D1683 (Standard Method for Failure in Sewn Seams of Woven Apparel Fabrics), 16 CFR 1610 (Flammability of Clothing Textiles), ASTM E96 (Water Vapor Transmission of Materials), and ANSI/AAMI PB70:2022 (Liquid Barrier performance and classification of protective apparel and drapes intended for use in healthcare facilities). All tests passed their respective acceptance criteria.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health and 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 square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
February 26, 2025
Medline Industries LP Kelsey Closen Regulatory Affairs Specialist Three Lakes Drive Northfield, Illinois 60093
Re: K242844
Trade/Device Name: Medline Level 4 Surgical Gown with Breathable Sleeves Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical Apparel Regulatory Class: Class II Product Code: FYA Dated: January 22, 2025 Received: January 22, 2025
Dear Kelsey Closen:
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.
1
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.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
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-regulatory
2
assistance/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,
ALLAN GUAN -S
For Bifeng Qian, M.D., Ph.D. Assistant Director DHT4C: Division of Infection Control Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
3
Indications for Use
510(k) Number (if known) K242844
Device Name
Medline Level 4 Surgical Gown with Breathable Sleeves
Indications for Use (Describe)
The Medline Level 4 Surgical Gown with Breathable Sleeves is a sterile, single use surgical apparel intended to be worn by healthcare professionals to help protect both the healtheare worker from the transfer of microorganisms, body fluids, and particulate matter. The Medline Level 4 Surgical Gown with Breathable Sleeves meets the Level 4 requirements of ANSI/AAMIPB70:2022 Liquid barrier performance and classification of protective apparel and drapes intended for use in healthcare facilities.
The Medline Level 4 Surgical Gown with Breathable Sleeves is also sold in a non-sterile version to re-packagers Kitting entities, to be sterilized using the validated ethylene oxide sterilization method according to ISO 11135-1 in its final finished form, as a kit component.
| 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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510(k) SUMMARY
[AS REQUIRED BY 21CFR807.92]
Submitter / 510(k) Sponsor
Medline Industries, Inc. Three Lakes Drive Northfield, IL 60093 Registration Number: 1417592
Submission Contact
Kelsey Closen Regulatory Affairs Specialist Phone: 847-949-2283 Email: kclosen@medline.com
Summary Preparation Date
February 26, 2025
Type of 510(k) Submission Traditional
Device Name / Classification
| Regulation Name: | Surgical Apparel |
|---|---|
| Classification Panel: | General & Plastic Surgery |
| Regulation Number: | 21 CFR 878.4040 |
| Common Name: | Surgical Gown |
| Classification Name: | Surgical Gown |
| Trade Name: | Medline Level 4 Surgical Gown with Breathable Sleeve |
| Product Code: | FYA |
| Classification Panel: | II |
Predicate Device
PREDICATE DEVICE:
- Medline Level 4 Surgical Gown, K182172 .
REFERENCE DEVICVE:
- . Medline Orbis Surgical Gown, K202447
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Device Description
The Medline Level 4 Surgical Gown with Breathable Sleeves is a single-use, sterile, disposable medical device that is provided in a variety of sizes (Large, X-Large, 3X-Large, 3X-Large and X-Long (only Sirus)) and styles (Sirus, Aurora and Eclipse). The Medline Level 4 Surgical Gown with Breathable Sleeves is constructed from nonwoven SMS (spunbond, meltblown, spunbond), a poly-fabric reinforcement on the chest front panel, and a breathable film (Polyester ether and polyester) for the sleeves. Each gown is designed with a hook and loop closure at the neck, ties at the waist, knitted cuffs at the end of the sleeves as well as a transfer tab for ease in donning. The Medline Level 4 Surgical Gown with Breathable Sleeves has been tested according to ANSI/AAMI PB70:2022 and meets AAMI Level 4 barrier level protection for a surgical gown.
Indication for Use
The Medline Level 4 Surgical Gown with Breathable Sleeves is a sterile, single use surgical apparel intended to be worn by healthcare professionals to help protect both the patient and the healthcare worker from the transfer of microorganisms, body fluids, and particulate matter. The Medline Level 4 Surgical Gown with Breathable Sleeves meets the Level 4 requirements of ANSI/AAMIPB70:2022 Liquid barrier performance and classification of protective apparel and drapes intended for use in healthcare facilities.
The Medline Level 4 Surgical Gown with Breathable Sleeves is also sold in a non-sterile version to repackagers/kitting entities, to be sterilized using the validated ethylene oxide sterilization method according to ISO 11135-1 in its final finished form, as a kit component.
| Device Characteristic | Proposed Device | Predicate Device | Comparison Analysis |
|---|---|---|---|
| Product Name | Medline Level 4 Surgical Gown with Breathable Sleeves | Medline Level 4 Surgical Gown | N/A |
| 510(k) Reference | K242844 | K182172 | N/A |
| Product Owner | Medline Industries, LP. | Medline Industries, LP. | Same |
| Product Code | FYA | FYA | Same |
| Intended Use | The Medline Level 4 Surgical Gown with Breathable Sleeves is a single use surgical apparel intended to be worn by healthcare professionals to help protect both the patient and the healthcare worker from the transfer of microorganisms, body fluids, and particulate matter. The Medline Level 4 Surgical Gown w/ Breathable Sleeves meets the Level 4 requirements of | The Medline Level 4 Surgical Gown is a sterile, single use surgical apparel intended to be worn by healthcare professionals to help protect both the patient and the healthcare worker from the transfer of microorganisms, body fluids, and particulate matter. The Medline Level 4 Surgical Gown meets the Level 4 requirements of ANSI/AAMI | Similar – the proposed device also includes how the gowns are to be used when bulk non-sterile. Predicate is only offered as sterile device. |
| ANSI/AAMIPB70:2022 Liquid | |||
| barrier performance and | |||
| classification of protective apparel | |||
| and drapes intended for use in | |||
| healthcare facilities. | |||
| The Medline Level 4 Surgical | |||
| Gown with Breathable Sleeves is | |||
| also sold in a non-sterile version | |||
| to re-packagers/kitting entities, to | |||
| be sterilized using the validated | |||
| ethylene oxide sterilization | |||
| method according to ISO 11135-1 | |||
| in its final finished form, as a kit | |||
| component. | PB70:2012 Liquid barrier | ||
| performance and classification of | |||
| protective apparel and drapes | |||
| intended for use in healthcare | |||
| facilities. | |||
| Regulation Number | 21 CFR 878.4040 | 21 CFR 878.4040 | Same |
| Gown Color | Blue | Blue | Same |
| Design Features | Neck Closure: Hook and Loop | ||
| Belt Ties | |||
| Knit Cuffs | |||
| Reinforced Material | |||
| Set-in/Standard Sleeves | Hoop & Neck Closures | ||
| Tie Waist Closure | |||
| Cuffs | |||
| Film Reinforcement | |||
| Sleeves | Similar - The proposed | ||
| has some design | |||
| features that differ | |||
| slightly from the | |||
| predicate but have the | |||
| same functions | |||
| Design Configurations | 3 Styles: Sirus, Eclipse, and | ||
| Aurora | |||
| Large, X-Large, 2X-Large, 3X- | |||
| Large and X-Long (only Sirus) | 3 Styles: Sirus, Eclipse, and | ||
| Aurora | |||
| Large, X-Large, 2X-Large, 3X- | |||
| Large (only Sirus) and X-Long | Similar- The proposed | ||
| device will have size | |||
| 3X-Large available in | |||
| the 3 sizes and size X- | |||
| Long will only be | |||
| available in Sirus | |||
| Material Composition | Nonwoven SMS polypropylene | ||
| Anti-Static, Repellency | |||
| Poly-Reinforcement Film | |||
| Breathable film (Polyester ether | |||
| and polyester) | |||
| White Knitted Cuffs | Nonwoven SMS polypropylene | ||
| Anti-Static, Repellency | |||
| Film Reinforcement | |||
| Cuffs | Similar- The proposed | ||
| device will have a poly- | |||
| reinforcement film and a | |||
| polyester ether and | |||
| polyester breathable film. | |||
| Prescription vs. OTC | OTC | OTC | Same |
| Contact Durations | Surface, Intact, ≤ 24 hours | Surface, Intact, ≤ 24 hours | Same |
| Sterile vs. Non-Sterile | Sterile, Non-Sterile | Sterile | Similar -the proposed |
| device will also be | |||
| available as bulk non- | |||
| sterile | |||
| Disposable vs. Non- | |||
| Disposable | Disposable | Disposable | Same |
| Single Use vs. Reusable | Single | Single | Same |
| Performance | |||
| Specifications: | Level 4 barrier protection | ||
| Breathability | Level 4 barrier protection | Similar - Refer to | |
| K202447 for | |||
| breathability claim | |||
| Biocompatibility | Meets requirements per: ISO | ||
| 10993-5 Cytotoxicity | |||
| ISO 10993-23 Irritation | |||
| ISO 10993-10 Sensitization | Under the test conditions, the | ||
| subject device was shown to be | |||
| non-cytotoxic, non-irritating, and | |||
| non-sensitizing per ISO 10993-5 | |||
| & ISO 10993-10 | Same | ||
| Flammability | Meets requirements of Flame | ||
| Resistant CPSC 16 CFR 1610 | |||
| Class 1 | Meets requirements of Flame | ||
| Resistant CPSC 16 CFR 1610 | |||
| Class 1 | Same | ||
| Sterilization Method | EO Sterilization | EO Sterilization | Same |
TABLE 1: COMPARISON OF PROPOSED AND PREDICATE DEVICES
6
7
Summary of Non-Clinical Testing
Non-clinical tests were conducted to verify that the proposed device met all design specifications. The subject surgical gown was assessed for performance using the following standards and test methods. The test results demonstrated that the proposed device met its acceptance criteria or testing endpoints.
| Standard | Standard Title | Acceptance Criteria | Results |
|---|---|---|---|
| ISO 10993-5 | |||
| Cytotoxicity | ISO MEM Elution Using L-929 | ||
| Mouse Fibroblast Cells | Non-cytotoxic | Pass- Non-cytotoxic | |
| ISO 10993-23 | |||
| Irritation | ISO Intracutaneous Irritation Test | Non-irritating | Pass- Non-irritating |
| ISO 10993-10 | |||
| Sensitization | ISO Guinea Pig Maximization | ||
| Sensitization Test | Non-sensitizing | Pass- Non-sensitizing | |
| ASTM F1671 | Resistance of Materials Used in | ||
| Protective Clothing to Penetration | |||
| by | |||
| Blood-Borne Pathogens | 4.0 AQL | Pass | |
| AATCC 42 | Water Resistance: Impact | ||
| Penetration Test | ≤4.5 g | Pass | |
| AATCC 127 | Water Resistance: Hydrostatic | ||
| Pressure Test | ≥50 cmH20 | Pass | |
| ASTM D5034- | |||
| 09 (2013) | Breaking Strength and Elongation | ||
| of Textile Fabrics (Grab Test) | ≥20 N | Pass | |
| ASTM D5587- | |||
| 15 | Tearing Strength of Fabrics by | ||
| Trapezoid Procedure | ≥20 N | Pass | |
| ASTM D1683 | Standard Method for Failure in | ||
| Sewn Seams of Woven Apparel | |||
| Fabrics | ≥20 N | Pass | |
| 16 CFR 1610 | Flammability of Clothing Textiles | Meets Class 1 Requirements | Pass |
| ASTM E96 | Water Vapor Transmission of | ||
| Materials | Reinforced | ||
| Outside Material >800 g/m²/24 hrs | Pass |
8
| Sleeve Material >1200 g/m²/24 hrs | Pass | ||
|---|---|---|---|
| ANSI/AAMI | |||
| PB70:2022 | Liquid Barrier performance and | ||
| classification of protective apparel | |||
| and drapes intended for use in | |||
| healthcare facilities. | Meets ANSI/AAMI | ||
| PB 70:2012 Level 3 | |||
| and Level 4 Liquid | |||
| Barrier requirements | Pass |
Summary of Clinical Testing
Not applicable.
Conclusion
The conclusions drawn from the non-clinical tests demonstrate that the Medline Level 4 Surgical Gown with Breathable Sleeves is as safe and as effective and perform as well as or better than the legally marketed predicate device, the Medline Level 4 Surgical Gown, K182172.