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

K192374 · Cardinal Health200, LLC · FXX · Dec 2, 2019 · General, Plastic Surgery

Device Facts

• Record ID: K192374
• Device Name: Cardinal Health™ Level 3 Surgical Mask with Anti-Fog Foam Strip
• Applicant: Cardinal Health200, LLC
• Product Code: FXX · General, Plastic Surgery
• Decision Date: Dec 2, 2019
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4040
• Device Class: Class 2

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.

Device Story

Four-layer surgical mask; nonwoven polyester/polyethylene blend inner/middle layers; polyolefin melt blown filter media; polyolefin spunbond outer layer. Features include ultrasonic welded edges, nonwoven polyolefin ties, and malleable nosepiece for fit. Includes anti-fog foam strip to minimize fogging. Used in operating rooms and clinical settings by healthcare personnel. Provides physical barrier against fluids and particulates. Protects wearer and patient from cross-contamination. Single-use, disposable, non-sterile.

Clinical Evidence

Bench testing only. Tested against ASTM F2100-11 Level 3 standards. Results: Synthetic blood penetration (160 mmHg, pass), BFE (99.7%), PFE at 0.1 micron (99.2%), Delta P (2.8 mm H2O/cm2), and Flammability (Class 1, did not ignite).

Technological Characteristics

Four-layer construction: nonwoven polyester/polyethylene blend (inner/middle), polyolefin melt blown (filter), polyolefin spunbond (outer). Pleated style, 7x4 inches. Malleable nosepiece, anti-fog foam strip, ultrasonic welded ties. Non-sterile, single-use. Tested per ASTM F2100-11, ASTM F1862, ASTM F2101, ASTM F2299, Mil-M-36954C, and CPSC 1610.

Indications for Use

Indicated for operating room personnel and general healthcare workers to protect against transfer of microorganisms, blood, body fluids, and airborne particulates. Single-use, disposable device.

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™ Level 3 Surgical Mask with Anti-Fog Foam Strip (Catalog # AT74535; K140155)

Submission Summary (Full Text)

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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 ([e-mail]) or phone [phone] 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)

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.

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) | <div> <span></span> </div> |

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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, LLC<br>3651 Birchwood Drive<br>Waukegan, IL 60085 |
|-----------------------------|-------------------------------------------------------------------------------------------------|
| Regulatory Affairs Contact: | Dominic Tunzi<br>300 South Riverside Plaza<br>Suite 2010<br>Chicago, IL 60606 |
| Telephone Number: | [phone] |
| Fax Number: | [phone] |
| Date Summary Prepared: | Nov 22, 2019 |
| Trade Name: | Cardinal Health™ Level 3 Surgical Mask with Anti-Fog<br>Foam 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-Fog<br>Foam 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.

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.

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 of<br>Comparison | Predicate Device (K140155):<br>Cardinal Health™ Level 3 Surgical<br>Mask with Anti-Fog Foam Strip | Subject Device (K192374):<br>Cardinal Health™ Level 3<br>Surgical Mask with Anti-Fog<br>Foam Strip | Comparison |
|--------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------|
| Intended Use | Cardinal Health™ Level 3 Surgical<br>Masks with Anti-Fog Foam Strip are<br>intended to be worn by operating<br>room personnel and other general<br>healthcare workers to protect both<br>patients and healthcare workers<br>against transfer of microorganisms,<br>blood and body fluids, and airborne<br>particulates. The Cardinal Health™<br>Level 3 surgical masks are single<br>use, disposable devices provided<br>non-sterile. | Cardinal Health™ Level Surgical<br>Masks with Anti-Fog Foam Strip<br>are intended to be worn by<br>operating room personnel and<br>other general healthcare workers<br>to protect both patients and<br>healthcare workers against<br>transfer of microorganisms,<br>blood and body fluids, and<br>airborne particulates. The<br>Cardinal Health™ Level 3<br>surgical masks are single use,<br>disposable devices provided non-<br>sterile. | Identical |
| Material Composition | Four-layer mask constructed of:<br><br>1 layer of nonwoven cellulose<br>(inner facing)<br><br>1 layer of nonwoven polyolefin melt<br>blown (filter media)<br><br>1 layer of nonwoven<br>polyester/polyethylene blend (middle<br>layer)<br><br>1 layer of polyolefin spunbond<br>material (outer facing) | Four-layer mask constructed of:<br><br>1 layer of nonwoven<br>polyester/polyethylene blend<br>(inner facing)<br><br>1 layer of nonwoven polyolefin<br>melt blown (filter media)<br><br>1 layer of nonwoven<br>polyester/polyethylene blend<br>(middle layer)<br><br>1 layer of polyolefin spunbond<br>material (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 and<br>malleable nosepiece | White Anti-fog foam strip, ties<br>and 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 in<br>accordance with ISO 10993 and<br>passed acceptance criteria. | The Cardinal Health™ Level 3<br>Surgical Mask with Anti-Fog<br>Foam Strip was tested in<br>accordance with ISO 10993 and<br>passed 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 Criteria<br>per ASTM F2100-11<br>Level 3 (AQL = 4.0%) | Subject Device<br>Test Results | |
|---------------------------------|---------------------------------------------------------------|------------------------------------------------------------------|------------------------------------------|----------------|
| | | | Test Results<br>ASTM F2100-11<br>Level 3 | Average |
| ASTM F1862<br>Synthetic Blood | Determine synthetic<br>blood penetration<br>resistance | 160 mmHg | Pass (31/32) | N/A |
| ASTM F2101<br>BFE | Determine the<br>bacterial filtration<br>efficiency | ≥ 98% | Pass (32/32) | 99.7% |
| ASTM F2299<br>PFE at 0.1 micron | Determine sub-<br>micron particulate<br>filtration efficiency | ≥ 98% | Pass (32/32) | 99.2% |
| Mil-M-36954C<br>Delta P | Determine breathing<br>resistance or<br>differential pressure | < 5.0 mm H2O/cm2 | Pass (32/32) | 2.8 mm H2O/cm2 |
| CPSC 1610<br>Flammability | Determine<br>flammability or flame<br>spread | 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.