Aero Chrome* Breathable Performance Surgical Gown

K153255 · Halyard Health, Inc. · FYA · Apr 13, 2016 · General, Plastic Surgery

Device Facts

• Record ID: K153255
• Device Name: Aero Chrome* Breathable Performance Surgical Gown
• Applicant: Halyard Health, Inc.
• Product Code: FYA · General, Plastic Surgery
• Decision Date: Apr 13, 2016
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4040
• Device Class: Class 2

Intended Use

The Aero Chrome* Breathable Performance Surgical Gowns are 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 Aero Chrome* Breathable Performance Surgical Gowns meet the Level 4 requirements of the AAMI PB70:2012 Liquid Barrier classifications. The Aero Chrome* Breathable Performance Surgical Gowns are also sold as bulk nonsterile, single use items, to repackager/relabeler establishments for further packaging and Ethylene Oxide (EtO) sterilization

Device Story

Aero Chrome* Breathable Performance Surgical Gown; sterile, single-use surgical apparel. Fabric construction: SFSMS (Spunbond/Film/Spunbond/Meltblown/Spunbond) laminate in critical zones; SMS (Spunbond/Meltblown/Spunbond) in non-critical back zones. Provides AAMI Level 4 liquid barrier protection in critical zones; AAMI Level 1 in non-critical zones. Used in surgical settings by healthcare professionals. Protects against transfer of microorganisms, body fluids, and particulates. Benefits patient and worker safety through barrier protection. Supplied sterile or as bulk non-sterile for repackaging/EtO sterilization.

Clinical Evidence

Bench testing only. No clinical data. Testing included AAMI PB70:2012 Level 4 liquid barrier performance, biocompatibility (ISO 10993-5, 10), flammability (16 CFR 1610), laser ignition resistance (ISO 11810-1), tensile strength (ASTM D5034), abrasion resistance (WSP 20.5), and synthetic blood penetration (ASTM F1670).

Technological Characteristics

Materials: Polypropylene and polyethylene polymer blend. Construction: SFSMS (critical zones) and SMS (non-critical zones) non-woven fabric. Barrier: AAMI PB70:2012 Level 4 (critical), Level 1 (non-critical). Sterilization: Ethylene Oxide (EtO). Form factor: Surgical gown in various sizes. Not made with natural rubber latex.

Indications for Use

Indicated for healthcare professionals as sterile, single-use surgical apparel to protect patients and workers from microorganisms, body fluids, and particulate matter.

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

• Aero Blue* Performance Surgical Gown (K140539)

Submission Summary (Full Text)

{0}------------------------------------------------

Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

April 13, 2016

Halyard Health, Inc. David Lee Associate Director, Regulatory Affairs 5405 Windward Parkway Alpharetta, Georgia 30004

Re: K153255

Trade/Device Name: Aero Chrome* Breathable Performance Surgical Gown Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical Apparel Regulatory Class: II Product Code: FYA Dated: March 7, 2016 Received: March 8, 2016

Dear David Lee:

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.

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

{1}------------------------------------------------

Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical devicerelated 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 Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/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 Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours.

Tejashri Purohit-Sheth, M.D.

Tejashri Purohit-Sheth, M.D. Clinical Deputy Director DAGRID/ODE/CDRH FOR

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

Enclosure

{2}------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

### Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.

510(k) Number (if known) K153255

Device Name Aero Chrome* Breathable Performance Surgical Gown

Indications for Use (Describe)

The Aero Chrome* Breathable Performance Surgical Gowns are 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 Aero Chrome* Breathable Performance Surgical Gowns meet the Level 4 requirements of the AAMI PB70:2012 Liquid Barrier classifications.

The Aero Chrome* Breathable Performance Surgical Gowns are also sold as bulk nonsterile, single use items, to repackager/relabeler establishments for further packaging and Ethylene Oxide (EtO) sterilization

| Type of Use (Select one or both, as applicable) | |
|-------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | <span> <input type="checkbox"/> Prescription Use (Part 21 CFR 801 Subpart D) </span> <span> <input checked="" type="checkbox"/> Over-The-Counter Use (21 CFR 801 Subpart C) </span> |

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

***DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.***

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and

Human Services Food and

Drug Administration

Office of Chief Information

Officer Paperwork

Reduction Act (PRA) Staff

[[e-mail]](mailto:[e-mail])

*"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."*

{3}------------------------------------------------

This submission addresses the Aero Chrome* Breathable Performance Surgical Gown models described below.

# STERILE CODES

| PRODUCT<br>STOCK CODE | DESCRIPTION | GOWN SIZE |
|-----------------------|-------------------------------------------------------------------|---------------|
| 44672 | Aero Chrome* Breathable Performance<br>Surgical Gown, S | Small |
| 44673 | Aero Chrome* Breathable Performance<br>Surgical Gown, L | Large |
| 44674 | Aero Chrome* Breathable Performance<br>Surgical Gown, XL | Xlarge |
| 44675 | Aero Chrome* Breathable Performance<br>Surgical Gown, XXL | XXLarge |
| 44676 | Aero Chrome* Breathable Performance<br>Surgical Gown, XXXL | XXXLarge |
| 44677 | Aero Chrome* Breathable Performance<br>Surgical Gown, L, X-Long | Large Xlong |
| 44678 | Aero Chrome* Breathable Performance<br>Surgical Gown, XL, X-Long | XLarge Xlong |
| 44679 | Aero Chrome* Breathable Performance<br>Surgical Gown, XXL, X-Long | XXLarge Xlong |

## NON-STERILE CODES

| PRODUCT | DESCRIPTION | GOWN SIZE |
|------------|----------------------------------------------------------------------|---------------|
| STOCK CODE | | |
| 44661NS | Aero Chrome* Breathable Performance<br>Surgical Gown, S | Small |
| 44662NS | Aero Chrome* Breathable Performance<br>Surgical Gown, L | Large |
| 44663NS | Aero Chrome* Breathable Performance<br>Surgical Gown, L - Handi-Bin | Large |
| 44664NS | Aero Chrome* Breathable Performance<br>Surgical Gown, XL | Xlarge |
| 44665NS | Aero Chrome* Breathable Performance<br>Surgical Gown, XL - Handi-Bin | Xlarge |
| 44666NS | Aero Chrome* Breathable Performance<br>Surgical Gown, XXL | XXLarge |
| 44667NS | Aero Chrome* Breathable Performance<br>Surgical Gown, L, X-Long | Large Xlong |
| 44668NS | Aero Chrome* Breathable Performance<br>Surgical Gown, XL, X-Long | XLarge Xlong |
| 44669NS | Aero Chrome* Breathable Performance<br>Surgical Gown, XXL, X-Long | XXLarge Xlong |

{4}------------------------------------------------

# 510(k) Summary

| Date Summary<br>was Prepared: | April 13, 2016 |
|-----------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k)<br>Submitter: | David M. Lee, JD<br>Associate Director of Regulatory Affairs,<br>HALYARD HEALTH<br>5405 Windward Parkway<br>Alpharetta, GA 30004<br>470 448 5182<br>[e-mail] |
| Primary Contact<br>for this 510(k)<br>Submission: | David M. Lee, JD<br>Associate Director of Regulatory Affairs,<br>HALYARD HEALTH<br>5405 Windward Parkway<br>Alpharetta, GA 30004<br>470 448 5182<br>[e-mail] |
| Device Trade<br>Name: | Aero Chrome* Breathable Performance Surgical Gown<br>(hereinafter described as "Aero Chrome*") |
| Device Common<br>Names | Surgical Gown |
| Device Product<br>Codes,<br>Classification<br>Name and<br>Regulation: | FYA<br>Class II<br>878.4040 Surgical Apparel |

{5}------------------------------------------------

#### Predicate Device

The Aero Chrome* Breathable Performance Surgical Gown under submission is substantially equivalent to the predicate device, the Aero Blue* Performance Surgical Gown (K140539).

Device The Aero Chrome* Breathable Performance Surgical Gowns Description: have a Spunbond/Film/Spunbond/Meltblown/Spunbond design (SFSMS) that provides AAMI Level 4 liquid barrier protection in the critical zones of the gown. The back of the Aero Chrome* Breathable Performance Surgical Gown in the non-critical zone has a SMS Spunbond/meltblown/spunbond) fabric that is air-breathable and provides AAMI Level 1 liquid barrier protection. The Aero Chrome* Breathable Performance Surgical Gowns are single use, disposable medical device that will be provided in a variety of sterile and non-sterile packaging configurations described below.

The Aero Chrome* Breathable Performance Surgical Gowns are Intended Use: 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 Aero Chrome* Breathable Performance Surgical Gowns meet the Level 4 requirements of the AAMI PB70:2012 Liquid Barrier classifications.

> The Aero Chrome* Breathable Performance Surgical Gowns are also sold as bulk non-sterile, single use items, to repackager/relabeler establishments for further packaging and Ethylene Oxide (EtO) sterilization

This submission covers the Aero Chrome* Breathable Performance Surgical Gowns models described below.

{6}------------------------------------------------

# Product Code and Description

# STERILE CODES

| PRODUCT STOCK<br>CODE | DESCRIPTION | GOWN SIZE |
|-----------------------|-------------------------------------------------------------------|---------------|
| 44672 | Aero Chrome* Breathable Performance<br>Surgical Gown, S | Small |
| 44673 | Aero Chrome* Breathable Performance<br>Surgical Gown, L | Large |
| 44674 | Aero Chrome* Breathable Performance<br>Surgical Gown, XL | Xlarge |
| 44675 | Aero Chrome* Breathable Performance<br>Surgical Gown, XXL | XXLarge |
| 44676 | Aero Chrome* Breathable Performance<br>Surgical Gown, XXXL | XXXLarge |
| 44677 | Aero Chrome* Breathable Performance<br>Surgical Gown, L, X-Long | Large Xlong |
| 44678 | Aero Chrome* Breathable Performance<br>Surgical Gown, XL, X-Long | XLarge Xlong |
| 44679 | Aero Chrome* Breathable Performance<br>Surgical Gown, XXL, X-Long | XXLarge Xlong |

# NON-STERILE CODES

| PRODUCT STOCK<br>CODE | DESCRIPTION | GOWN SIZE |
|-----------------------|-------------------------------------------------------------------|---------------|
| 44661NS | Aero Chrome* Breathable Performance Surgical Gown, S | Small |
| 44662NS | Aero Chrome* Breathable Performance Surgical Gown, L | Large |
| 44663NS | Aero Chrome* Breathable Performance Surgical Gown, L - Handi-Bin | Large |
| 44664NS | Aero Chrome* Breathable Performance Surgical Gown, XL | Xlarge |
| 44665NS | Aero Chrome* Breathable Performance Surgical Gown, XL - Handi-Bin | Xlarge |
| 44666NS | Aero Chrome* Breathable Performance Surgical Gown, XXL | XXLarge |
| 44667NS | Aero Chrome* Breathable Performance Surgical Gown, L, X-Long | Large Xlong |
| 44668NS | Aero Chrome* Breathable Performance Surgical Gown, XL, X-Long | XLarge Xlong |
| 44669NS | Aero Chrome* Breathable Performance Surgical Gown, XXL, X-Long | XXLarge Xlong |

{7}------------------------------------------------

#### Summary of Non-Clinical Testing

| Standard or Reference | Test Method | Data Generated | Meets<br>Requirement |
|-----------------------------------------------------------------------------------------------------------------------------------------|---------------------------|------------------------------------------------------------------------------------------------|------------------------------------------------------------------------|
| Standard for the Flammability for Clothing Textiles | 16 CFR 1610 | Flammability | Pass |
| ISO 10993-5:2009 Biological Evaluation of Medical<br>Devices-Part 5: | Cytotoxicity | Cytotoxicity | Pass, under the<br>conditions of the<br>study non-<br>cytotoxic |
| ISO 10993-10:2010 Biological Evaluation of Medical<br>Devices-Part 10 | Skin Irritation Study | Irritation | Pass, under the<br>conditions of the<br>study a<br>negligible irritant |
| ISO 10993-10:2010 Biological Evaluation of Medical<br>Devices-Part 10 | Sensitization Test | Sensitization | Pass, under the<br>conditions of the<br>study non-<br>sensitizing |
| ISO 10993-7:2008, Ethylene Oxide sterilization<br>residuals | EO residuals | EO residuals | Pass |
| Laser Ignition Resistance | ISO 11810-1 (2005) | Laser resistance | Pass |
| AAMI Liquid Barrier Performance in Critical Zone<br>(body, sleeves, and ties) | AAMI PB70:2012<br>Level 4 | Resistance to<br>Penetration by<br>Blood-Borne<br>Pathogens Using<br>Phi-X174<br>Bacteriophage | Pass |
| AAMI Liquid Barrier Performance Level 1 in non-critical<br>side seams, raglan sleeve to shoulder seams, and<br>SMS area in back of gown | AAMI PB70:2012<br>Level 1 | Water resistance | Pass |
| Spray Impact<br>(1.2 osy SMS in non-critical zone on back) | AATCC 42:2013 | Water resistance | Pass |
| Grab Tensile, Peak Stretch, and Peak Energy -<br>Nonwovens | ASTM D5034<br>(2009) | Tensile Strength | Pass |
| Abrasion Resistance and Surface Bonding of SMS<br>Laminates | WSP 20.5 (2008) | Abrasion resistance | Pass |
| Synthetic Blood Penetration<br>(fabric only in critical zone) | ASTM-1670-08<br>(2008) | Resistance to<br>penetration | Pass |
| Mass Per Area (Basis Weight) of Materials | D3776 (2009) | Fabric basis weight | Pass |
| Water Vapor Transmission Rate Through Nonwovens<br>and Plastic Films | WSP<br>70.4 (2008) | Water Vapor<br>Transmission | Pass |
| Degree Peel Strength of Laminated Nonwovens - Raw<br>Materials | STM-00197(2010) | Peel Strength | Pass |
| Resistance to Linting Dry Particle Generation | INDA WSP 160.1<br>(2009) | Particulate | Pass |

Test results establish that the product met the predetermined specifications.

{8}------------------------------------------------

#### Substantial Equivalence Table

| Attribute | Device Under Submission:<br>Aero Chrome* Breathable<br>Performance Surgical Gown | Predicate Device of this 510(k):<br>K140539 Aero Blue*<br>Performance Surgical Gown |
|--------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications<br>for Use | The Aero Chrome* Breathable<br>Performance Surgical Gowns are<br>sterile, single use surgical apparel<br>intended to be worn by healthcare<br>professionals to help protect both the<br>patient and the healthcare worker from<br>the transfer of microorganisms, body<br>fluids, and particulate matter. The Aero<br>Chrome* Breathable Performance<br>Surgical Gowns meet the Level 4<br>requirements of the AAMI PB70:2012<br>Liquid Barrier classifications.<br><br>The Aero Chrome* Breathable<br>Performance Surgical Gowns are also<br>sold as bulk non-sterile, single use<br>items, to repackager/relabeler<br>establishments for further packaging<br>and Ethylene Oxide (EtO) sterilization | Aero Blue* Performance Surgical<br>Gowns, are sterile, single use surgical<br>apparel intended to be worn by<br>healthcare professionals to help protect<br>both the patient and the healthcare<br>worker from the transfer of<br>microorganisms, body fluids, and<br>particulate matter.<br>The Aero Blue* Performance<br>Surgical Gowns meet the Level 3<br>requirements of the AAMI PB70: 2012<br>Liquid Barrier classifications.<br><br>The Aero Blue* Performance Surgical<br>Gowns, are also sold as bulk non-<br>sterile, single use items, to<br>repackager/relabeler establishments for<br>further packaging and Ethylene Oxide<br>(EtO) sterilization. |
| How<br>supplied | Sterile ( $10^{-6}$ ) or bulk non-sterile | Same |
| Sterilization<br>Method | Ethylene Oxide | Same |
| SAL | $10^{-6}$ | Same |
| Gown color | Gray | Blue |
| Gown sizes | Small, Large, X-Large, XX-Large,<br>XXX-Large, L X-Long, XXL X- Long | Small, Large, X-Large, XX-Large,<br>XXX-Large |
| Construction<br>Overview | The Aero Chrome* Breathable<br>Performance Surgical Gowns under<br>submission are manufactured from a<br>moisture-vapor breathable, repellent,<br>non-woven fabric using a polymer<br>blend of polypropylene and<br>polyethylene. The front body and<br>sleeve fabric is a three layer film<br>laminate. This fabric is an SFSMS<br>design Spunbond/Film/Spunbond-<br>Meltblown-Spunbond that is adhesively<br>bonded together. The Aero Chrome*<br>Breathable Performance Surgical<br>Gowns in the critical zone meet AAMI-<br>4 liquid barrier requirements, while<br>back of gown in the non-critical zone is<br>composed of a breathable SMS fabric<br>with an AAMI level 1 liquid barrier<br>protection. | The Aero Blue Performance Surgical<br>Gown is manufactured from a<br>moisture-vapor breathable, repellent,<br>non-woven fabric using a polymer<br>blend of polypropylene and<br>polyethylene. The front body and<br>sleeve fabric is a three layer film<br>laminate. This fabric is an SFSMS<br>design Spunbond/<br>Film/Spunbond-Meltblown-Spunbond<br>that is adhesively bonded together.<br>Front of Gown meets meet AAMI-3<br>liquid barrier requirements, while back<br>of Gown in the non-critical zone is<br>composed of a breathable SMS fabric<br>with an AAMI level 1 liquid barrier<br>protection. |

{9}------------------------------------------------

| Not<br>made<br>with<br>natural<br>rubber<br>latex | Yes | Same |
|---------------------------------------------------|-----|------|
|---------------------------------------------------|-----|------|

### Performance Testing

| Attribute | Device Under Submission:<br>Aero Chrome* Breathable Performance<br>Surgical Gowns | Predicate Device of this<br>510(k):<br>K140539 Aero Blue*<br>Performance Surgical Gown, |
|--------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------|
| Performance<br>Testing in<br>Critical Zone | ANSI/AAMI PB70: 2012 Level 4 Liquid Barrier<br>Requirements - Pass | ANSI/AAMI PB70: 2012 Level<br>3 |
| | W SP 70.4 (STM-00164)-W ater Vapor<br>Transmission Rate - Pass | Same |
| | W SP 160.1 (STM-00353) Test Method for<br>Resistance to Linting: Dry Particle Generation<br>with a Modified Gelbo Flex Unit -Pass | Same |
| | ASTM D 5034 - 2009 Standard Test Method For<br>Breaking Strength and Elongation of Textile<br>Fabrics (Grab Test) - Pass | Same |
| | ASTM F1670:2008 for fabric in critical zone-<br>Pass | Same |
| | STM- 00149 (W SP 20.5 2008), Abrasion<br>Resistance Test - Pass | Same |
| | Biocompatibility per ISO 10993 – Pass, the<br>device under the conditions of the study is non-<br>cytotoxic, non-irritant, and non-sensitizing. | Same, device under the<br>conditions of the study was non-<br>cytotoxic, non-irritant, and non-<br>sensitizing. |
| | 16 CFR, Chapter II--Consumer Product Safety<br>Commission Part 1610 -Standard For The<br>Flammability of Clothing Textiles Class I - Pass | Same |
| | Laser Ignition Resistance/ ISO 11810- Pass | Same |

Conclusion The performance testing submitted for the Aero Chrome* Breathable Performance Surgical Gown demonstrates substantial equivalence to the predicate Aero Blue* Performance Surgical Gown (K140539) in intended use, design, materials, performance, and biocompatibility attributes.

*Registered Trademark or Trademark of Halyard Health, Inc. or its affiliates.