SECURE-GARD SURGICAL AND PROCEDURE FACE MASK

K140155 · Cardinal Health200, LLC · FXX · Jun 20, 2014 · General, Plastic Surgery

Device Facts

• Record ID: K140155
• Device Name: SECURE-GARD SURGICAL AND PROCEDURE FACE MASK
• Applicant: Cardinal Health200, LLC
• Product Code: FXX · General, Plastic Surgery
• Decision Date: Jun 20, 2014
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4040
• Device Class: Class 2

Intended Use

Cardinal Health Secure-Gard® surgical and procedure masks 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 Secure-Gard® surgical and procedure masks are single use, disposable devices provided non-sterile.

Device Story

Secure-Gard surgical and procedure masks are four-layer, single-use, disposable face masks. Construction includes inner nonwoven cellulose, two middle layers of nonwoven polyolefin melt blown and polyester/polyethylene blend media, and an outer nonwoven polyolefin spunbond layer. Layers are sonically welded; masks feature malleable nosepieces for fit. Variants include ties or earloops, with optional integrated eye shields or anti-fog foam strips. Used in clinical settings by healthcare personnel to provide a barrier against microorganisms, blood, body fluids, and airborne particulates. Masks are worn over the nose and mouth to reduce exposure risk for both patient and wearer.

Clinical Evidence

Bench testing only. Performance evaluated against ASTM F2100-11 Level 3 standards. Results: Synthetic blood penetration (160 mmHg) passed; BFE 99.4-99.7%; PFE (0.1 micron) 98.6-99.1%; Delta P 3.1-3.5 mmH2O/cm²; Flammability Class 1. All 32/32 samples passed.

Technological Characteristics

Four-layer construction: nonwoven cellulose (inner), nonwoven polyolefin melt blown (media), nonwoven polyester/polyethylene blend (media), polyolefin spunbond (outer). Sonic welding. Malleable nosepiece. Ties or polyester-spandex earloops. Tested to ASTM F2100-11 Level 3. Biocompatibility per ISO 10993. Non-sterile.

Indications for Use

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

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

• Kimberly-Clark, KC300 Face Mask(s) (K111402)

Submission Summary (Full Text)

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JUN 2 0 2014

K140155

Image /page/0/Picture/2 description: The image shows the logo for Cardinal Health. The logo consists of a stylized bird-like graphic above the company name. The company name, "CardinalHealth", is written in a simple, sans-serif font.

1500 Waukegan Road
Waukegan, IL 60085

www.cardinalhealth.com

510(k) SUMMARY Secure-Gard® Surgical and Procedure Masks

Manufacturer:

Cardinal Health 200, LLC 1500 Waukegan Road Waukegan, IL 60085

> 1500 Waukegan Road Waukegan, IL 60085

Lavenia Ford

[phone]

[phone]

Surgical Mask

FXX

Regulatory Affairs Contact:

Telephone Number:

Fax Number:

Date summary Prepared: May 21, 2014

Trade Name:

Secure-Gard® Surgical Mask
Secure-Gard® Procedure Mask

Regulation Number/Device Class: Class II per 21 CFR § 878.4040

Regulation Name: Surgical Apparel

Common Name:

Procedure Mask

Product Code:

Predicate Device:

K111402 -Kimberly-Clark, KC300 Face Mask(s)

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### Description

The Cardinal Health Secure-Gard® surgical and procedure masks are identified by Regulation 21 CFR 878.4040 with product code FXX.

The Cardinal Health Secure-Gard® surgical and procedure masks are all the same four-layer masks constructed of 1 layer of nonwoven cellulose (inner facing), 1 layer of nonwoven polvolefin melt blown (media). 1 laver of nonwoven polyester/polvethylene blends (media), 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 or polyester-spandex earloops (both attached by ultrasonic welding). A malleable nosepiece is placed within the binding for comfort and individualized fit around the wearer's nose. The surgical masks will be provided with or without an eye shield. Cardinal Health surgical and procedure masks are a single use, disposable device provided non-sterile

#### Indications for Use

Cardinal Health Secure-Gard® surgical and procedure masks 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 Secure-Gard® surgical and procedure masks are single use, disposable devices provided non-sterile.

This submission covers 7 catalog numbers of Secure-Gard® surgical and procedure masks models, see Table 1 below. Each model is the same four-laver mask constructed of 1 laver of nonwoven cellulose (inner facing), 1 layer of nonwoven polyolefin melt blown (media), 1 layer of nonwoven polyester/polyethylene blends (media), and 1 layer polyolefin spunbond material (outer facing) and has been tested according to ASTM 2100-11 Standard Specification for Performance of Materials Used in Medical Face Masks.

| Catalog # | Trade Name | Design Features | Color |
|-----------|-----------------------------|------------------------------------------------------------|-----------------|
| AT74535 | Secure-Gard® surgical mask | Anti-fog foam strip<br>and ties | Teal and Purple |
| AT74635 | Secure-Gard® surgical mask | Anti-fog foam strip,<br>eye shield, and ties | Teal and Purple |
| AT74635-1 | Secure-Gard® surgical mask | Anti-fog foam strip,<br>anti-glare eye shield,<br>and ties | Teal and Purple |
| AT744235 | Secure-Gard® surgical mask | Light weight anti-fog<br>strip and ties | Teal and Purple |
| AT744335 | Secure-Gard® surgical mask | Light weight anti-fog<br>strip with eye shield<br>and ties | Teal and Purple |
| AT74531 | Secure-Gard® procedure mask | Earloops | Teal and Purple |
| AT74631 | Secure-Gard® procedure mask | Eye shield and<br>earloops | Teal and Purple |

#### Table 1: Product Description and Catalog Number

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## Device and Predicate Device Technical Characteristics

The Cardinal Health Secure-Gard® surgical and procedure face masks are substantially equivalent to the predicate device Kimberly-Clark KC300 of K111402 in intended use and principles of operation see Table 3 below. The Cardinal Health Secure-Gard® surgical and procedure masks and predicate masks meet ASTM F2100-11 as shown below in Table 11.

| Element of Comparison | Kimberly-Clark (KC300) | Cardinal Health Secure-Gard® Surgical and Procedure Masks |
|-----------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | The Kimberly Clark KC300 Face Mask(s) is intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids, and particulate material. These face masks are intended for use in infection control practices to reduce the potential exposure of the wearer to blood and body fluids. The Kimberly Clark KC300 face mask(s) is a single use, disposable device(s), provided non-sterile. | <b>Secure-Gard Surgical Mask</b><br>Cardinal Health Secure-Gard® surgical masks 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 Secure-Gard® surgical masks are single use, disposable devices provided non-sterile<br><br><b>Secure-Gard Procedure Mask</b><br>Cardinal Health Secure-Gard® procedure masks 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 Secure-Gard® procedure masks are single use, disposable devices provided non-sterile |
| Material Composition | 4 layer mask made from nonwoven polyester blends and polypropylene materials | <b>Secure-Gard Surgical Mask</b><br>4 layer mask made from 1 layer of nonwoven cellulose (inner facing), 1 layer of nonwoven polyolefin melt blown (media), 1 layer of nonwoven polyester/polyethylene blends (media), and 1 layer polyolefin spunbond material (outer facing)<br><br><b>Secure-Gard Procedure Mask</b><br>4 layer mask made from 1 layer of nonwoven cellulose (inner facing), 1 layer of nonwoven polyolefin melt blown (media) 1 |

| Table 3: Comparison of Predicate device and Cardinal Health Secure-Gard® Surgical and | | | | |
|---------------------------------------------------------------------------------------|--|--|--|--|
| Procedure masks | | | | |

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| | | layer of nonwoven<br>polyester/polyethylene blends<br>(media), and 1 layer polyolefin<br>spunbond material (outer facing) |
|-------------------------------|----------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Specifications and Dimensions | KC300 Surgical Mask<br>7.0"x3.7" | Secure-Gard Surgical Mask<br>AT74535 - 7"x4" |
| | KC300 Procedure Mask<br>6.9"x3.8" | AT74635 - 7 ¼"x4 1/8"<br>AT74635-1 - 7 ¼"x4 1/8"<br>AT744235 - 7"x4"<br>AT744335 - 7"x4" |
| | | Secure-Gard Procedure Mask<br>AT74531 - 7"x3 3/8"<br>AT74631 - 7"x3 3/8" |
| | | See Appendix I for mask<br>specifications |
| Mask Style | Pleated | Secure-Gard Surgical Mask<br>Pleated |
| | | Secure-Gard Procedure Mask<br>Pleated |
| Design Features | KC300 Surgical Mask<br>Fluidshield Fog-Free | Secure-Gard Surgical Mask<br>AT74535 - Anti-fog foam strip<br>and Ties<br>AT74635 - Anti-fog foam strip,<br>Eye shield, and Ties<br>AT74635-1 - Anti-fog foam strip,<br>Anti-glare eye shield, and Ties<br>AT744235 - Lightweight anti-fog<br>strip and Ties<br>AT744335 - Lightweight anti-fog<br>strip, Eye shield, and Ties |
| | KC300 Procedure Mask<br>Fluidshield Fog-Free | Secure-Gard Procedure Mask<br>AT74531 - Earloops<br>AT74631 - Eye shield and<br>Earloops |
| Physical Testing | Predicate device was tested<br>according to ASTM F2100-11<br>Level 3 in previous 510(k)<br>submission K111402. | Secure-Gard Surgical Mask<br>Device was tested in accordance<br>with ASTM F2100-11, and meets<br>Level 3 requirements |
| | | Secure-Gard Procedure Mask<br>Device was tested in accordance<br>with ASTM F2100-11, and meets<br>Level 3 requirements |
| | | See Appendix G for all test data |
| Biocompatibility | Predicate device was tested<br>according ISO 10993 | Secure-Gard Surgical Mask<br>Device was tested in accordance<br>to ISO 10993 and passed |

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| acceptance criteria |
|-----------------------------------------------------------------------------------------------------------------|
| Secure-Gard Procedure Mask<br>Device was tested in accordance<br>to ISO 10993 and passed<br>acceptance criteria |
| Appendix H for all test data |

## Summary of Testing

The Cardinal Health Secure-Gard® surgical and procedure masks 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 11 below.

# Table 11: Summary of ASTM F2100-11 Testing - Cardinal Health Secure-Gard® Surgical and Procedure Masks compared to Predicate

| Test | Acceptance<br>Criteria per<br>ASTM F2100-<br>11 Level 3<br>(AQL = 4.0%) | Predicate<br>device test<br>results<br>K111402<br>(KC300) | Current device test results | |
|------------------------------------|-------------------------------------------------------------------------|-----------------------------------------------------------|-----------------------------|-----------------------|
| | | | ASTM<br>F2100-11<br>Level 3 | Average |
| ASTM F1862<br>Synthetic<br>Blood | 160 mmHg | Pass | 32/32 Pass | Not Applicable |
| ASTM F2101<br>BFE | ≥ 98% | Pass | 32/32 Pass | 99.4 - 99.7% |
| ASTM F2299<br>PFE at 0.1<br>micron | ≥ 98% | Pass | 32/32 Pass | 98.6 - 99.1% |
| Mil-M-<br>36954C<br>Delta P | < 5.0<br>mmH₂0/cm² | Pass | 32/32 Pass | 3.1- 3.5<br>mmH₂0/cm² |
| CPSC 1610<br>Flammability | Class 1 | Pass | 32/32 Pass<br>Class 1 | Not Applicable |

All results of testing met ASTM F2100-11 Level 3 acceptance criteria. ASTM F2100-11 Level 3 was performed at an AQL of 4% (32 samples tested, accept on 3 failures and reject on 4 failures).

## Summary of Testing

Based on the results of the biocompatibility and physical performance testing the Secure-Gard® surgical and procedure masks are as safe and as effective for their intended use as the predicate. The Secure-Gard® surgical and procedure masks are substantially equivalent to the predicate device, in terms of general intended use performance testing, material composition, configurations/dimensions, and safety and effectiveness.

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#### DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-000

June 20, 2014

Cardinal Health 200, LLC Ms. Lavenia Ford Manager, Regulatory Affairs 1430 Waukegan Road Waukegan, Illinois 60085

Re: K140155

Trade/Device Name: Secure-Gard® Surgical and Procedure Masks Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical Mask Regulatory Class: Class II Product Code: FXX Dated: May 21, 2014 Received: May 22, 2014

Dear Ms. Ford,

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. 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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Page 2 - Ms. Ford

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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDeyices/Safety/ReportalProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Tejashri Purohit-Sheth, M.D.

Tejashri Tejashri Purohit-Sheth Purohit Sheth M.D M.D. Cusical Deputy Director

GRODE/CDRH FOR

Erin I. Keith, M.S. Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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#### DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

# Indications for Use

510(k) Number (if known) K140155

Device Name

Secure-Gard® surgical and procedure masks

Indications for Use (Describe)

Cardinal Health Secure-Gard® surgical and procedure masks are intended to be worn by operating room personnel and other general healthcare workers to protect both patients against transfer of microorganisms, blood and body fluids, and airborne particulates. The Cardinal Health Secure-Gard® surgical and procedure masks are single use, disposable devices provided non-sterile.

This submission covers 7 catalog numbers of Secure-Gard® surgical and procedure masks models, see Table 1 below. Each model is the same four-layer mask constructed of I layer of nonwoven cellulose (inner facing), 1 layer of nonwoven polyolefin melt blown (media), 1 layer of nonwoven polyester/polyethylene blends (media), and 1 layer polyolefin spunbond material (outer facing) and has been tested according to ASTM F2100-11 Standard Specification for Performance of Materials Used in Medical Face Masks

Table 1: Product Description and Catalog Number

| Catalog # | Trade Name | Design Features | Color |
|-----------|-----------------------------|------------------------------------------------------|-----------------|
| AT74535 | Secure-Gard® surgical mask | Anti-fog foam strip and ties | Teal and Purple |
| AT74635 | Secure-Gard® surgical mask | Anti-fog foam strip, eye shield, and ties | Teal and Purple |
| AT74635-I | Secure-Gard® surgical mask | Anti-fog foam strip, anti-glare eye shield, and ties | Teal and Purple |
| AT744235 | Secure-Gard® surgical mask | Light weight anti-fog strip and ties | Teal and Purple |
| AT744335 | Secure-Gard® surgical mask | Light weight anti-fog strip with eye shield and ties | Teal and Purple |
| AT74531 | Secure-Gard® procedure mask | Earloops | Teal and Purple |
| AT74631 | Secure-Gard® procedure mask | Eye shield and earloops | Teal and Purple |

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

L Prescription Use (Part 21 CFR 801 Subpart D)

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

# PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

A MARK LE FOR FOR FOR FOR FOR FOR FOR FOR FOR FOR FOR FOR FOR THE CHILL Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

Sreekanth Gu

ly signed by Sreekanth Gutala -S

JS, o=U.S. Government, ou=HHS, ou=FDA, ou=People, 9200300.100.1.1=2000540490. cn=Sreekanth Gutala -S 2044.06.19 21:59:43 -04'00'

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