The Medline Surgical Face Mask and Medline Procedural Face Mask are intended to be worn to protect both the patient and the healthcare worker from the transfer of microorganisms, body fluids, and particulate material. These face masks are intended for use in infection control practices to reduce the potential exposure to blood and body fluids. These masks are single use, disposable, non-sterile devices.

Device Description

The Medline Surgical Face Mask and Medline Procedural Face Mask are single-use, disposable device, provided non-sterile. Depending on the configurations, the Medline Surgical Face Mask and Medline Procedural Face Mask are composed of three or four layers of nonwoven materials: an outer layer, middle filtration layer(s) and an inner facing layer. The outer/inner facing layers are constructed of non-woven fabric and the middle filtration layer(s) are constructed of melt blown non-woven fabric. Each mask contains tie strings or ear loops to secure the user's face and mouth, and come in a flat pleated style that includes a malleable nosepiece to provide a firm fit over the nose. The Medline Surgical Face Mask and Medline Procedural Face Mask may also come equipped with an antifog foam stripe, anti-glare stripe and/or a face shield to cover the upper part of the face. The Medline Surgical Face Mask and Medline Procedural Face Mask may also be provided in an ASTM Fluid level of Level 1, Level 2 or Level 3. The color of the facemasks will be available in white, yellow, blue, or pink stripes.

AI/ML Overview

The provided document is a 510(k) Premarket Notification for a Medline Surgical Face Mask and Medline Procedural Face Mask. It primarily focuses on demonstrating substantial equivalence to a predicate device, which is different from an AI/ML medical device where the emphasis would be on the performance of an algorithm.

Therefore, the document does not contain the information requested regarding the acceptance criteria and study proving an AI/ML device meets those criteria. Specifically, it lacks data on:

A table of acceptance criteria and reported device performance: This document specifies performance criteria and test results for physical properties of surgical masks (e.g., bacterial filtration efficiency, fluid resistance, flammability), not for the performance of an AI/ML algorithm.
Sample size used for the test set and data provenance: No test set for an AI/ML algorithm is mentioned.
Number of experts used to establish ground truth and their qualifications: Not applicable to a physical mask.
Adjudication method for the test set: Not applicable.
Multi-reader multi-case (MRMC) comparative effectiveness study: Not applicable.
Standalone (algorithm only) performance: Not applicable.
Type of ground truth used: Not applicable.
Sample size for the training set: No training set for an AI/ML algorithm is mentioned.
How ground truth for the training set was established: Not applicable.

Instead, the document details:

Device Name: Medline Surgical Face Mask and Medline Procedural Face Mask
Intended Use: To protect both the patient and healthcare worker from the transfer of microorganisms, body fluids, and particulate material; for use in infection control practices to reduce potential exposure to blood and body fluids. Single use, disposable, non-sterile.
Predicate Device: Surgical Masks with Ear Loops or Ties, Level 1, Level 2, Level 3 (K202598)
Non-Clinical Testing: Performance testing was completed based on standards like ISO 10993 (biocompatibility), ASTM F2101-19 (Bacterial filtration efficiency), ASTM F1862 (Resistance to penetration by synthetic blood), 16 CFR Part 1610 (Flammability), ASTM F2100 (Performance of Materials), EN 14683:2019 (Differential Pressure), and ASTM F2299 (Sub-micron particulate filtration efficiency).
Clinical Testing: Not applicable (as stated in the document).

In summary, this document is for a medical device (surgical face mask) with physical performance requirements, not an AI/ML medical device, and therefore does not contain the specific information requested in the prompt about AI/ML device validation.

Summary

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

March 24, 2023

Medline Industries, LP Kelsey Closen Regulatory Affairs Specialist Three Lakes Drive Northfield, Illinois 60093

Re: K223236

Trade/Device Name: Medline Surgical Face Mask and Medline Procedural Face Mask Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical Apparel Regulatory Class: Class II Product Code: FXX Dated: February 3, 2023 Received: February 22, 2023

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 (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

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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 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 (QS) 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 medical devices and radiation-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,

Katherine D. Kavlock -S

for

Brent Showalter, Ph.D. Assistant Director DHT6B: Division of Spinal Devices OHT6: Office of Orthopedic 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) K223236

Device Name

Medline Surgical Face Mask and Medline Procedural Face Mask

Indications for Use (Describe)

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

Recreational Use (Part 91, CFR 90.1 Subpart D)
Commercial Use (91 CFR 90.1 Subpart C)

_ | Prescription Use (Part 21 CFR 801 Subpart D)

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

CONTINUE ON A SEPARATE PAGE IF NEEDED.

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K223236 Page 1 of 4

Image /page/3/Picture/1 description: The image features the logo of Medline, a healthcare company. The logo is set against a blue background and consists of the word "MEDLINE" in a bold, sans-serif font, positioned to the left of a stylized starburst or cross-like symbol. The symbol is white, creating a strong contrast against the blue, and it appears to be a central element of the logo's design.

Medline Industries, LP Three Lakes Drive Northfield. IL 60093

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

Submitter / 510(k) Sponsor

Medline Industries, LP Three Lakes Drive Northfield, IL 60093

Registration Number: 1417592

Contact Person

Contact Person: Kelsey Closen, Regulatory Affairs Specialist Phone: 847-949-2283 Email: KClosen@medline.com

Summary Preparation Date October 7, 2022

Type of 510(k) Submission Traditional

Device Name / Classification

Trade Name: Medline Surgical Face Mask and Medline Procedural Face Mask Common Name: Surgical Mask Classification Name: Mask, Surgical Product Code: FXX Classification Panel: Orthopedic Regulatory Class: II Regulation Number: 21 CFR 878.4040

Predicate Device

K202598: Surgical Masks with Ear Loops or Ties, Level 1, Level 2, Level 3

Device Description

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Image /page/4/Picture/1 description: The image features the Medline logo, which is set against a blue square background. The word "MEDLINE" is written in white, bold, sans-serif letters. A white, stylized starburst or cross-like symbol is positioned behind the text, with its center aligned with the middle of the word. A gray bar is located in the upper right corner of the image.

Aedline Industries. Three Lakes Drive Northfield, IL 60093

Each mask contains tie strings or ear loops to secure the user's face and mouth, and come in a flat pleated style that includes a malleable nosepiece to provide a firm fit over the nose. The Medline Surgical Face Mask and Medline Procedural Face Mask may also come equipped with an antifog foam stripe, anti-glare stripe and/or a face shield to cover the upper part of the face. The Medline Surgical Face Mask and Medline Procedural Face Mask may also be provided in an ASTM Fluid level of Level 1, Level 2 or Level 3. The color of the facemasks will be available in white, yellow, blue, or pink stripes.

Indications for Use

The Medline Surgical Face Mask and Medline Procedural Face Mask is intended to be worn to protect both the patient and the healthcare worker from the transfer of microorganisms, body fluids, and particulate material. These face masks are intended for use in infection control practices to reduce the potential exposure to blood and body fluids. These masks are single use, disposable, non-sterile devices.

Summary of Technological Characteristics

TABLE 1: COMPARISON OF PROPOSED AND PREDICATE DEVICES

DeviceCharacteristic	Proposed Device	Predicate Device	ComparisonAnalysis
Product Name	Medline Surgical Face Mask and MedlineProcedural Face Mask	Surgical Masks with Ear Loops or Ties, Level 1,Level 2, Level 3	N/A
510(k)Reference	TBD	K202598	N/A
Product Owner	Medline Industries LP	3A Medical Products Co., Ltd	N/A
RegulationNumber	878.4040	878.4040	Same
Product Code	FXX	FXX	Same
Intended Use	This mask is intended to be worn toprotect both the patient and the healthcareworker from the transfer ofmicroorganisms, body fluids, andparticulate material. These face masks areintended for use in infection controlpractices to reduce the potential exposureto blood and body fluids. These masks aresingle use, disposable, non-sterile devices	This mask is intended to be worn to protect boththe patient and healthcare worker from the transferof microorganisms, body fluids and Particulatematerial. This mask is intended for use in infectioncontrol practices to reduce the potential exposureto blood and body fluids. This is a single usedevice provided nonsterile.	Same
Design Features	PleatedNose Piece	PleatedNose Piece	Similar-Additionally
	Face Shield	Ties	Medline offers thefacemask in a faceshield, anti-glareand anti- fog style.There are no safetyor risk concern withthese optionalfeatures.
	Anti-glare strip	Ear loops
	Anti-fog foam strip
	Ties
	Ear loops
ColorConfigurations			Similar – Medlineoffers the facemasksin more colors.There is no safety orrisk concern withthe additional colorsbased onbiocompatibilitytesting
	Blue
	Yellow	Blue
	White
	Pink Stripe
Materials	Face Mask:		Similar – Medlineoffers more fabricvariations but thereis no safety or riskconcern based onperformance andbiocompatibilitytesting
	1. Spunbond/Meltblown/Spunbond
	2. Cellulose/Meltblown/Spunbond
	3. Cellulose/Meltblown/Cellulose
	4. Cellulose/MeltblownSpunbond/Cellulose	Face Mask:1. Polypropylene/Spunbond/Polypropylene2. Polypropylene/Meltblown/Polypropylene
	5. Thermalbond/Meltblown/Spunbond
	Ear Loops:	Ear Loops:1. Polyester/Spandex
	1. PP& Lycra2. Polyester & Spandex3. Polypropylene4. Polyester, Spandex & Urethane
	Ties:1. PP	Ties:1. Polypropylene Spunbond
	Nose Strip:1. HDPE, Paper, Wire2. Polypropylene & iron3. Aluminum4. Iron & PE5. Steel & PE	Nose Strip :1. Polyethylene coated Steel Wire
Prescription vs.OTC	OTC	OTC	Same

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Image /page/5/Picture/0 description: The image features the Medline logo against a blue background. The logo consists of the word "MEDLINE" in a sans-serif font, positioned to the left of a stylized white graphic. The graphic resembles a starburst or a stylized medical symbol, with sharp, angular lines converging towards a central point.

Medline Industries, LP
Three Lakes Drive
Northfield, IL 60093

K223236 Page 3 of 4

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Image /page/6/Picture/0 description: The image shows the Medline logo. The logo consists of the word "MEDLINE" in a sans-serif font, with a stylized white starburst or lightning bolt symbol positioned vertically behind the text. The background is a solid dark blue color. The logo is simple and modern, with a clean design.

Sterile vs. Non-Same Non-Sterile Non-Sterile Sterile Disposable vs. Same Disposable Disposable Non-Disposable Same Single Use vs. Single Use Single Use Reusable ASTM F2100 Same Level 1, 2, 3 Level 1, 2, 3 Level

Summary of Non-Clinical Testing

Non-clinical performance testing was completed on the Medline Surgical Face Mask and Medline Procedural Face Mask to demonstrate the safety and effectiveness of the subject device with the relevant test methods described in Table 2 below.

ISO 10993-5	ISO MEM Elution Using L-929 Mouse Fibroblast Cells
ISO 10993-10	Repeated Patch Dermal Sensitization Test
ISO 10993-10	ISO Intracutaneous Irritation Test
ISO 10993-1	Biological evaluation of medical devices -- Part 1: Evaluation and testing within a risk management process
ASTM F2101-19	Bacterial filtration efficiency (BFE)
ASTM F1862	Resistance to penetration by synthetic blood
16 CFR Part 1610	Standard for the Flammability of Clothing
ASTM F2100	Standard Specification for Performance of Materials Used in Medical Face Masks
EN 14683:2019	Differential Pressure (Delta-P)
ASTM F2299	Sub-micron particulate filtration efficiency (PFE)

Table 2. Non-Clinical Performance Testing Standards

Medline Industries, LP Three Lakes Drive Northfield, IL 60093

Summary of Clinical Testing

Not applicable.

Conclusion

In accordance with 21 CFR Part 807, and based on the information provided in this premarket notification, Medline Industries, LP. concludes that the Medline Surgical Face Mask and Medline Procedural Face Mask are as safe and as effective for their intended use as the predicate device, Surgical Masks with Ear Loops or Ties, Level 1, Level 2, Level 3 (K202598).

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.