The Cardinal Health™ Level 3 surgical masks with Anti-Fog Foam Strip are intended to be worn by operating room personnel and other general healthcare workers to protect both patients and healthcare workers against transfer of microorganisms, blood and body fluids, and airborne particulates. The Cardinal Health™ Level 3 surgical masks are single use, disposable devices provided non-sterile.

Device Description

The Cardinal Health™ Level 3 Surgical Mask with Anti-Fog Foam Strip is a four-layer mask constructed of 1 layer of nonwoven polyester/polyethylene blend (inner facing), 1 layer of nonwoven polyolefin melt blown (filter media), 1 layer of nonwoven polyester/polyethylene blend (middle layer), and 1 layer polyolefin spunbond material (outer facing). The four layers of the mask body are collated and sonically welded around the edges to enclose the filter media. The mask is provided with nonwoven polyolefin ties attached by ultrasonic welding. A malleable nosepiece is placed within the binding for comfort and individualized fit around the wearer's nose. The Anti-Fog Foam Strip is intended to minimize fogging.

AI/ML Overview

The provided text describes the acceptance criteria and the study conducted for the Cardinal Health™ Level 3 Surgical Mask with Anti-Fog Foam Strip (K192374).

Here's the breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance:

Test	Purpose	Acceptance Criteria per ASTM F2100-11 Level 3 (AQL = 4.0%)	Reported Device Performance (Test Results)	Average Performance
ASTM F1862 Synthetic Blood	Determine synthetic blood penetration resistance	160 mmHg	Pass (31/32)	N/A
ASTM F2101 BFE	Determine the bacterial filtration efficiency	≥ 98%	Pass (32/32)	99.7%
ASTM F2299 PFE at 0.1 micron	Determine sub-micron particulate filtration efficiency	≥ 98%	Pass (32/32)	99.2%
Mil-M-36954C Delta P	Determine breathing resistance or differential pressure	< 5.0 mm H2O/cm2	Pass (32/32)	2.8 mm H2O/cm2
CPSC 1610 Flammability	Determine flammability or flame spread	Class 1	Pass (32/32)	Did Not Ignite

2. Sample size used for the test set and the data provenance:

Sample Size: For all tests (synthetic blood penetration, BFE, PFE, Delta P, and Flammability), the sample size was 32.
Data Provenance: The document does not specify the country of origin or whether the data was retrospective or prospective. It only states that the tests were conducted according to established ASTM and CPSC standards.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

This information is not applicable to a surgical mask. The "ground truth" for a device like a surgical mask is established by objective physical and chemical performance tests against predefined standards, not by expert interpretation or judgment of images or clinical data.

4. Adjudication method for the test set:

This information is not applicable. As mentioned above, the "ground truth" is based on objective measurements and predefined acceptance criteria in engineering and material science, not on expert adjudication of ambiguous cases.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

This information is not applicable. The device is a surgical mask, not an AI-powered diagnostic or assistive technology that would involve human readers or AI assistance.

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

This information is not applicable. The device is a surgical mask and does not involve any algorithms or AI for standalone performance.

7. The type of ground truth used:

The ground truth used for this device is based on objective performance standards and measurements as defined by:

ASTM F2100-11, Standard Specification for Performance of Materials Used in Medical Face Masks (which includes ASTM F1862, ASTM F2101, ASTM F2299, and Mil-M-36954C)
CPSC 1610 for Flammability

These standards define the physical and material properties that classify a surgical mask for a particular performance level (Level 3 in this case).

8. The sample size for the training set:

This information is not applicable. The device is a physical product (surgical mask) and does not involve AI or machine learning models that require training sets.

9. How the ground truth for the training set was established:

This information is not applicable for the same reason as point 8.

Summary

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Image /page/0/Picture/0 description: The image shows the logos of the Department of Health & Human Services and the U.S. Food & Drug Administration. The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. Food & Drug Administration" in blue.

Cardinal Health 200, LLC Dominic Tunzi Regulatory Affairs Manager 3651 Birchwood Drive Waukegan, Illinois 60085

Re: K192374

Trade/Device Name: Cardinal Health Level 3 Surgical Mask with Anti-Fog Foam Strip Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical Apparel Regulatory Class: Class II Product Code: FXX Dated: August 29, 2019 Received: August 30, 2019

Dear Dominic Tunzi:

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,

For Elizabeth Claverie, M.S. Assistant Director DHT4B: Division of Infection Control and Plastic Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known)

K192374

Device Name

Cardinal Health™ Level 3 Surgical Mask with Anti-Fog Foam Strip

Indications for Use (Describe)

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/3/Picture/0 description: The image contains the logo for Cardinal Health. The logo consists of a stylized red bird-like design above the company name. The company name "CardinalHealth" is written in a bold, sans-serif font, with the "C" capitalized and the rest of the letters in lowercase.

3651 Birchwood Drive Waukegan, IL 60085 www.cardinalhealth.com

510(k) SUMMARY Cardinal Health™ Level 3 Surgical Mask with Anti-Fog Foam Strip K192374

Manufacturer:	Cardinal Health 200, LLC3651 Birchwood DriveWaukegan, IL 60085
Regulatory Affairs Contact:	Dominic Tunzi300 South Riverside PlazaSuite 2010Chicago, IL 60606
Telephone Number:	(312) 270-2172
Fax Number:	(312) 775-9324
Date Summary Prepared:	Nov 22, 2019
Trade Name:	Cardinal Health™ Level 3 Surgical Mask with Anti-FogFoam Strip
Regulation Number:	21 CFR §878.4040
Device Class:	Class II
Regulation Name:	Surgical Apparel
Common/Classification Name:	Surgical Mask
Product Code:	FXX
Predicate Device:	Cardinal Health™ Level 3 Surgical Mask with Anti-FogFoam Strip (Catalog # AT74535; K140155)

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Description

The Cardinal Health™ Level 3 Surgical Mask with Anti-Fog Foam Strip is a Class II medical device under Regulation 21 CFR 878.4040, Surgical apparel and the FDA product code of FXX. The device description of the Cardinal Health™ Level 3 Surgical Mask with Anti-Fog Foam Strip is in accordance with the Guidance on Surgical Masks - Premarket Notification [510(k)] Submissions, issued on March 5, 2004.

This submission is for one (1) surgical mask model:

Catalog Number: AT73635 Description: Surgical Mask with Anti-Fog Foam Strip Color: White

Indications for Use/Intended Use

Cardinal Health™ Level 3 Surgical Masks with Anti-Fog Foam Strip are intended to be worn by operating room personnel and other general healthcare workers to protect both patients and healthcare workers against transfer of microorganisms, blood and body fluids, and airborne particulates. The Cardinal Health™ Level 3 surgical masks are single use, disposable devices provided non-sterile.

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Technical Characteristics

Table 5.1

Comparison of Predicate and Proposed devices

Element ofComparison	Predicate Device (K140155):Cardinal Health™ Level 3 SurgicalMask with Anti-Fog Foam Strip	Subject Device (K192374):Cardinal Health™ Level 3Surgical Mask with Anti-FogFoam Strip	Comparison
Intended Use	Cardinal Health™ Level 3 SurgicalMasks with Anti-Fog Foam Strip areintended to be worn by operatingroom personnel and other generalhealthcare workers to protect bothpatients and healthcare workersagainst transfer of microorganisms,blood and body fluids, and airborneparticulates. The Cardinal Health™Level 3 surgical masks are singleuse, disposable devices providednon-sterile.	Cardinal Health™ Level SurgicalMasks with Anti-Fog Foam Stripare intended to be worn byoperating room personnel andother general healthcare workersto protect both patients andhealthcare workers againsttransfer of microorganisms,blood and body fluids, andairborne particulates. TheCardinal Health™ Level 3surgical masks are single use,disposable devices provided non-sterile.	Identical
Material Composition	Four-layer mask constructed of:1 layer of nonwoven cellulose(inner facing)1 layer of nonwoven polyolefin meltblown (filter media)1 layer of nonwovenpolyester/polyethylene blend (middlelayer)1 layer of polyolefin spunbondmaterial (outer facing)	Four-layer mask constructed of:1 layer of nonwovenpolyester/polyethylene blend(inner facing)1 layer of nonwoven polyolefinmelt blown (filter media)1 layer of nonwovenpolyester/polyethylene blend(middle layer)1 layer of polyolefin spunbondmaterial (outer facing)	Similar
Dimensions	7 inches x 4 inches	7 inches x 4 inches	Identical
Mask Style	Pleated	Pleated	Identical
Design Features	Blue Anti-fog foam strip, ties andmalleable nosepiece	White Anti-fog foam strip, tiesand malleable nosepiece	Similar
Sterility	Non-Sterile	Non-Sterile	Identical
Use	Single Use; Disposable	Single Use; Disposable	Identical
Color	Multicolor	White	Different
Biocompatibility	The predicate device was tested inaccordance with ISO 10993 andpassed acceptance criteria.	The Cardinal Health™ Level 3Surgical Mask with Anti-FogFoam Strip was tested inaccordance with ISO 10993 andpassed acceptance criteria.	Similar

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Summary of Nonclinical Testing

The Cardinal Health™ Level 3 Surgical Masks with Anti-Fog Foam Strip have been tested according to ASTM 2100-11 and standards which comprise ASTM F2100-11, Standard Specification for Performance of Materials Used in Medical Face Masks. See Table 5.2 for a testing summary.

Table 5.2

Test	Purpose	Acceptance Criteriaper ASTM F2100-11Level 3 (AQL = 4.0%)	Subject DeviceTest Results
			Test ResultsASTM F2100-11Level 3	Average
ASTM F1862Synthetic Blood	Determine syntheticblood penetrationresistance	160 mmHg	Pass (31/32)	N/A
ASTM F2101BFE	Determine thebacterial filtrationefficiency	≥ 98%	Pass (32/32)	99.7%
ASTM F2299PFE at 0.1 micron	Determine sub-micron particulatefiltration efficiency	≥ 98%	Pass (32/32)	99.2%
Mil-M-36954CDelta P	Determine breathingresistance ordifferential pressure	< 5.0 mm H2O/cm2	Pass (32/32)	2.8 mm H2O/cm2
CPSC 1610Flammability	Determineflammability or flamespread	Class 1	Pass (32/32)	Did Not Ignite

Summary of ASTM F2100-11 Testing

All results of testing met ASTM F2100-11 Level 3 acceptance criteria.

Conclusion Summary

The conclusions drawn from the nonclinical tests demonstrate that the subject Cardinal Health™ Level 3 Surgical Mask with Anti-Fog Foam Strip is as safe, as effective, and performs as well as or better than the legally marketed predicate device cleared under K140155.

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.