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 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.

AI/ML Overview

This document describes the performance testing for the Medline Level 4 Surgical Gown with Breathable Sleeves (K242844), a surgical apparel device. The information provided is based on non-clinical testing only, as no clinical testing was performed for this 510(k) submission.

Here's an analysis of the acceptance criteria and the study proving the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance:

Standard	Standard Title	Acceptance Criteria	Reported Device Performance (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
		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

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

The document describes non-clinical tests conducted to verify design specifications. For each test listed in the table, the "Results" column indicates a "Pass," meaning the acceptance criteria were met.

Sample Size: The specific sample sizes for each non-clinical test (e.g., number of fabric specimens tested for ASTM F1671) are not detailed in this summary. The 510(k) summary typically provides a high-level overview, and the detailed test reports (which FDA reviews) would contain this information.
Data Provenance: The tests are generally performed by accredited testing laboratories or the manufacturer's own qualified labs. The document does not specify the country of origin of the data. Given it's an FDA submission, the tests would typically adhere to recognized international standards like ISO and ASTM. These are prospective tests performed specifically to support the regulatory submission of this new device.

3. Number of Experts Used to Establish Ground Truth and Qualifications:

Not Applicable. For this type of medical device (surgical gowns), "ground truth" is established through adherence to standardized, objective performance tests (e.g., measuring water resistance, breaking strength, biocompatibility). These are not studies that rely on expert interpretation of images or clinical outcomes to establish ground truth in the way an AI diagnostic device would.

4. Adjudication Method for the Test Set:

None. Adjudication methods (like 2+1, 3+1) are relevant for studies involving human interpretation or clinical endpoints, often in the context of diagnostic accuracy or clinical trials. As this is a non-clinical performance evaluation against objective standards, no adjudication method is used. The results are quantitative measurements interpreted against pre-defined thresholds.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done:

No, an MRMC comparative effectiveness study was not done. This type of study is typically performed for diagnostic devices (especially those involving image interpretation by human readers) to assess how an AI algorithm impacts reader performance. The Medline Level 4 Surgical Gown is a protective apparel, not a diagnostic device, and its performance is evaluated through physical and material property tests, not human reader studies.

6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done:

Not Applicable. This question typically pertains to AI/ML software as a medical device (SaMD). The Medline Level 4 Surgical Gown is a physical medical device. Its performance is inherent in its material properties and manufacturing, not an algorithm.

7. The Type of Ground Truth Used:

The "ground truth" for this device's performance is established by objective, quantitative measurements against published national and international standards. This includes:

Biocompatibility Standards: ISO 10993 series (Cytotoxicity, Irritation, Sensitization).
Barrier Performance Standards: ASTM F1671 (blood-borne pathogens), AATCC 42 (impact penetration), AATCC 127 (hydrostatic pressure), and ANSI/AAMI PB70:2022 (overall liquid barrier performance classification).
Material Strength Standards: ASTM D5034 (breaking strength), ASTM D5587 (tearing strength), ASTM D1683 (sewn seam failure).
Other Performance Standards: 16 CFR 1610 (flammability), ASTM E96 (water vapor transmission/breathability).

The "ground truth" is therefore the measured physical and chemical properties of the gown, compared against the predefined acceptance criteria of these standard test methods.

8. The Sample Size for the Training Set:

Not Applicable. The concept of a "training set" is relevant for machine learning algorithms. This device is a manufactured product, not an AI algorithm. Its design and manufacturing process would involve material selection and engineering, not machine learning training.

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

Not Applicable. As there is no training set for an AI algorithm, this question is not relevant.

Summary

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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.

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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.

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

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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

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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

Indication for Use

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 Liquidbarrier performance andclassification of protective appareland drapes intended for use inhealthcare facilities.The Medline Level 4 SurgicalGown with Breathable Sleeves isalso sold in a non-sterile versionto re-packagers/kitting entities, tobe sterilized using the validatedethylene oxide sterilizationmethod according to ISO 11135-1in its final finished form, as a kitcomponent.	PB70:2012 Liquid barrierperformance and classification ofprotective apparel and drapesintended for use in healthcarefacilities.
Regulation Number	21 CFR 878.4040	21 CFR 878.4040	Same
Gown Color	Blue	Blue	Same
Design Features	Neck Closure: Hook and LoopBelt TiesKnit CuffsReinforced MaterialSet-in/Standard Sleeves	Hoop & Neck ClosuresTie Waist ClosureCuffsFilm ReinforcementSleeves	Similar - The proposedhas some designfeatures that differslightly from thepredicate but have thesame functions
Design Configurations	3 Styles: Sirus, Eclipse, andAuroraLarge, X-Large, 2X-Large, 3X-Large and X-Long (only Sirus)	3 Styles: Sirus, Eclipse, andAuroraLarge, X-Large, 2X-Large, 3X-Large (only Sirus) and X-Long	Similar- The proposeddevice will have size3X-Large available inthe 3 sizes and size X-Long will only beavailable in Sirus
Material Composition	Nonwoven SMS polypropyleneAnti-Static, RepellencyPoly-Reinforcement FilmBreathable film (Polyester etherand polyester)White Knitted Cuffs	Nonwoven SMS polypropyleneAnti-Static, RepellencyFilm ReinforcementCuffs	Similar- The proposeddevice will have a poly-reinforcement film and apolyester ether andpolyester 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 proposeddevice will also beavailable as bulk non-sterile
Disposable vs. Non-Disposable	Disposable	Disposable	Same
Single Use vs. Reusable	Single	Single	Same
PerformanceSpecifications:	Level 4 barrier protectionBreathability	Level 4 barrier protection	Similar - Refer toK202447 forbreathability claim
Biocompatibility	Meets requirements per: ISO10993-5 CytotoxicityISO 10993-23 IrritationISO 10993-10 Sensitization	Under the test conditions, thesubject device was shown to benon-cytotoxic, non-irritating, andnon-sensitizing per ISO 10993-5& ISO 10993-10	Same
Flammability	Meets requirements of FlameResistant CPSC 16 CFR 1610Class 1	Meets requirements of FlameResistant CPSC 16 CFR 1610Class 1	Same
Sterilization Method	EO Sterilization	EO Sterilization	Same

TABLE 1: COMPARISON OF PROPOSED AND PREDICATE DEVICES

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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 10993-5Cytotoxicity	ISO MEM Elution Using L-929Mouse Fibroblast Cells	Non-cytotoxic	Pass- Non-cytotoxic
ISO 10993-23Irritation	ISO Intracutaneous Irritation Test	Non-irritating	Pass- Non-irritating
ISO 10993-10Sensitization	ISO Guinea Pig MaximizationSensitization Test	Non-sensitizing	Pass- Non-sensitizing
ASTM F1671	Resistance of Materials Used inProtective Clothing to PenetrationbyBlood-Borne Pathogens	4.0 AQL	Pass
AATCC 42	Water Resistance: ImpactPenetration Test	≤4.5 g	Pass
AATCC 127	Water Resistance: HydrostaticPressure Test	≥50 cmH20	Pass
ASTM D5034-09 (2013)	Breaking Strength and Elongationof Textile Fabrics (Grab Test)	≥20 N	Pass
ASTM D5587-15	Tearing Strength of Fabrics byTrapezoid Procedure	≥20 N	Pass
ASTM D1683	Standard Method for Failure inSewn Seams of Woven ApparelFabrics	≥20 N	Pass
16 CFR 1610	Flammability of Clothing Textiles	Meets Class 1 Requirements	Pass
ASTM E96	Water Vapor Transmission ofMaterials	ReinforcedOutside Material >800 g/m²/24 hrs	Pass

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		Sleeve Material >1200 g/m²/24 hrs	Pass
ANSI/AAMIPB70:2022	Liquid Barrier performance andclassification of protective appareland drapes intended for use inhealthcare facilities.	Meets ANSI/AAMIPB 70:2012 Level 3and Level 4 LiquidBarrier 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.

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.