AERO CHROME* Select Breathable Performance Surgical Gown, AERO CHROME* A-Line Breathable Performance Surgical Gown

K210688 · O&M Halyard, Inc. · FYA · Jul 21, 2021 · General, Plastic Surgery

Device Facts

• Record ID: K210688
• Device Name: AERO CHROME* Select Breathable Performance Surgical Gown, AERO CHROME* A-Line Breathable Performance Surgical Gown
• Applicant: O&M Halyard, Inc.
• Product Code: FYA · General, Plastic Surgery
• Decision Date: Jul 21, 2021
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 878.4040
• Device Class: Class 2

Intended Use

The AERO CHROME* Select 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 micro-organisms, body fluids, and particulate matter. The AERO CHROME* Select Breathable Performance Surgical Gowns meet the Level 4 AAMI PB70:2012 Liquid Barrier classifications. The AERO CHROME* A-Line Breathable Performance Surgical Gowns are surgical apparel intended to be worn by healthcare professionals to help protect both the patient and the healthcare worker from the transfer of micro-organisms, body fluids, and particulate matter. The AERO CHROME* A-Line Breathable Performance Surgical Gowns meet the Level 4 AAMI PB70:2012 Liquid Barrier classifications.

Device Story

Surgical gowns designed for healthcare professionals to provide barrier protection against microorganisms, body fluids, and particulates. Constructed from moisture-vapor breathable, non-woven fabric using a polypropylene and plastomer polymer blend. Critical zones utilize a three-layer SMS/F/SMS (Spunbond-Meltblown-Spunbond/Film/Spunbond-Meltblown-Spunbond) laminate design, adhesively bonded with polyolefin hot melt. Sleeves are heat-sealed to meet AAMI Level 4 liquid barrier requirements. The 'Select' model features a continuous material design for front and back without side seams; the 'A-Line' model features a lightweight, breathable SMS back panel providing AAMI Level 1 protection. Supplied sterile via Ethylene Oxide or as bulk non-sterile product. Used in surgical environments to reduce cross-contamination risk between patients and staff.

Clinical Evidence

Bench testing only. No clinical data. Performance verified via ANSI/AAMI PB70:2012 (Level 4 critical zone, Level 1 non-critical), ASTM D5034 (tensile strength), ASTM F1670 (synthetic blood penetration), ISO 9073-10 (linting), 16 CFR 1610 (flammability), and ISO 10993 series (biocompatibility/cytotoxicity/irritation/sensitization).

Technological Characteristics

Materials: Polypropylene/plastomer non-woven fabric, CaCO3-filled film, polyolefin hot melt adhesive. Design: SMS/F/SMS laminate (critical zone). Barrier: AAMI PB70:2012 Level 4 (critical), Level 1 (non-critical). Sterilization: Ethylene Oxide (SAL 10^-6). Standards: ASTM D5034, ASTM F1670, ISO 9073-10, ISO 10993, 16 CFR 1610, ISO 11810-1 (Laser ignition resistance).

Indications for Use

Indicated for healthcare professionals as sterile, single-use surgical apparel to protect patients and workers from transfer of 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 CHROME* Breathable Performance Surgical Gowns (K200522)

Submission Summary (Full Text)

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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 is in blue and includes the letters "FDA" in a square and the words "U.S. Food & Drug Administration".

July 21, 2021

O&M Halyard, Inc Steve Dowdley Global Products, Director of Regulatory Affairs 1 Edison Drive Alpharetta, Georgia 30005

## Re: K210688

Trade/Device Name: AERO CHROME* Select Breathable Performance Surgical Gown, AERO CHROME* A-Line Breathable Performance Surgical Gown Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical Apparel Regulatory Class: Class II Product Code: FYA Dated: July 16, 2021 Received: July 19, 2021

Dear Steve Dowdley:

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,

Clarence W. Murray, III, PhD Acting Assistant Director DHT4B: Division of Infection Control and Plastic Surgery Devices OHT4: Office of Surgical and Infection Control 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)

#### Device Name

AERO CHROME* Select Breathable Performance Surgical Gowns, AERO CHROME* A-Line Breathable Performance Sugraal Gowns

#### Indications for Use (Describe)

The AERO CHROME* Select Breathable Performance Surgical Gowns are sterile, single use surgical apparel intended to be worn by healthcate professionals to help protect both the healthcare worker from the transfer of microorganisms, body fluids, and particulate matter The AERO CHROME* Select Breathable Performance Surgical Gowns meet the Level 4 AAMI PB70:2012 Liquid Barrier classifications

| Non-Sterile Product Codes | | |
|---------------------------|---------------------------------------------------------------|-----------|
| Product Code | Device Description Gown | Gown Size |
| 44696NS | AERO CHROME* Select Breathable Performance Surgical Gown, L | Large |
| 44697NS | AERO CHROME* Select Breathable Performance Surgical Gown, XL | X-Large |
| 44698NS | AERO CHROME* Select Breathable Performance Surgical Gown, XXL | XX-Large |
| Sterile Product Codes | | |
| Product | Device Description Gown | Gown Size |
| 44699 | AERO CHROME*Select Breathable Performance Surgical Gown, L | Large |
| 44706 | AERO CHROME* Select Breathable Performance Surgical Gown, XL | X-Large |
| 44707 | AERO CHROME* Select Breathable Performance Surgical Gown, XXL | XX-Large |

The AERO CHROME* A-Line Breathable Performance Surgical Gowns are surgical apparel intended to be worn by healthcare professionals to help protect both the patient and the healthcare worker from the transfer of micro-organisms, body fluids, and particulate matter The AERO CHROME* A-Line Breathable Performance Surgical Gowns meet the Level 4 AAMI PB70 2012 Liquid Ba111er classifications.

| Sterile Product Codes | |
|-------------------------|---------------------------------------------------------------------------------|
| Product | 47580 |
| Device Description Gown | AERO CHROME* A-Line Breathable Performance Surgical Gown with Towel, XL, X-Long |
| Gown Size | X-Large, X-Long |

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)
### CONTINUE ON A SEPARATE PAGE IF NEEDED.

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Image /page/4/Picture/0 description: The image contains two company logos. The first logo is for Owens & Minor, featuring the company's initials in a bold, maroon color with horizontal lines, followed by the company name in gray. The second logo is for Halyard, consisting of a green and white triangular shape resembling a roof, accompanied by the company name in bold, dark blue letters.

K210688

## 510(k) Summary

| 510(k)<br>Number: | K210688 |
|----------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Date<br>Prepared: | March 05, 2021 |
| 510(k)<br>Sponsor: | O&M Halyard Inc.<br>9120 Lockwood Boulevard<br>Mechanicsville, VA 23116 |
| Regulatory<br>Contact: | Steven Dowdley<br>1 Edison Drive<br>Alpharetta, GA 30005<br>678-451-8062<br>[e-mail] |
| Device Trade<br>Names: | AERO CHROME* Select Breathable Performance Surgical Gowns AERO<br>CHROME* A-Line Breathable Performance Surgical Gowns |
| Device<br>Common<br>Name: | Surgical Gown |
| FDA Device<br>Product Code: | FYA |
| FDA Device<br>Classification: | Class II |
| FDA Device<br>Name: | Gown, Surgical |
| FDA<br>Regulation<br>Number: | 21 CFR 878.4040 |
| Predicate | K200522 – AERO CHROME* Breathable Performance Surgical Gowns |
| Device | |
| Descriptions: | The AERO CHROME* Select Breathable Performance Surgical Gowns<br>have a SMS/F/SMS design (Spunbond-Meltblown-<br>Spunbond/Film/Spunbond-Meltblown-Spunbond) that provides a<br>PB70:2012 Level 4 Liquid Barrier Performance Barrier in the critical<br>zone. The back of the gown is comprised of the identical fabric as the<br>front of the gown and meets AAMI Level 1 Liquid Barrier Performance<br>Barrier. |
| | The AERO CHROME* Select Breathable Performance Surgical Gown is a<br>single use gown, supplied sterile (via Ethylene Oxide) or as bulk non-<br>sterile product. The gowns come in the following various sizes: Large, X-<br>Large, XX-Large. |
| | The AERO CHROME* A-Line Breathable Performance Surgical Gowns<br>have a SMS/F/SMS design (Spunbond-Meltblown-<br>Spunbond/Film/Spunbond-Meltblown-Spunbond) that provides a<br>PB70:2012 Level 4 Liquid Barrier Performance Barrier in the critical<br>zone. The back of the gown is lightweight, air-breathable, and provides<br>AAMI Level 1 protection. |
| | The AERO CHROME* A-Line Breathable Performance Surgical Gown is a<br>single use gown, supplied sterile (via Ethylene Oxide) or as bulk non-<br>sterile product. The gowns come in an X-Long, X- Large size. |
| Indications for<br>Use for AERO<br>CHROME*<br>Select<br>Breathable<br>Performance<br>Surgical<br>Gowns: | The AERO CHROME* Select Breathable Performance Surgical Gowns are<br>sterile, single use surgical apparel intended to be worn by healthcare<br>professionals to help protect both the patient and the healthcare worker<br>from the transfer of micro-organisms, body fluids, and particulate matter.<br>The AERO CHROME* Select Breathable Performance Surgical Gowns meet<br>the Level 4 AAMI PB70:2012 Liquid Barrier classifications. |
| Indications for<br>Use for AERO<br>CHROME* A-<br>Line<br>Breathable<br>Performance<br>Surgical<br>Gowns: | The AERO CHROME* A-Line Breathable Performance Surgical Gowns are<br>sterile, single use surgical apparel intended to be worn by healthcare<br>professionals to help protect both the patient and the healthcare worker<br>from the transfer of micro-organisms, body fluids, and particulate matter.<br>The AERO CHROME* A-Line Breathable Performance Surgical Gowns<br>meet the Level 4 AAMI PB70:2012 Liquid Barrier classifications. |

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Image /page/5/Picture/0 description: The image features the logos of two companies, Owens & Minor and Halyard. The Owens & Minor logo is on the left, with the company name in gray text next to a maroon emblem. The Halyard logo is on the right, with the company name in blue text next to a blue circle containing a white and green shape.

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Image /page/6/Picture/0 description: The image shows the logos of two companies, Owens & Minor and Halyard. The Owens & Minor logo is on the left and consists of the letters "OM" in a stacked, horizontal line pattern, with the words "Owens & Minor" to the right of the letters. The Halyard logo is on the right and consists of a blue circle with a white and green abstract shape inside, with the word "HALYARD" in blue to the right of the circle.

## Product Codes Subject to this Premarket Notification

| Product<br>Code | Device Description |
|-----------------|---------------------------------------------------------------------------------|
| 44696NS | AERO CHROME* Select Breathable Performance Surgical Gown, L |
| 44697NS | AERO CHROME* Select Breathable Performance Surgical Gown, XL |
| 44698NS | AERO CHROME* Select Breathable Performance Surgical Gown, XXL |
| 44699 | AERO CHROME* Select Breathable Performance Surgical Gown, L |
| 44706 | AERO CHROME* Select Breathable Performance Surgical Gown, XL |
| 44707 | AERO CHROME* Select Breathable Performance Surgical Gown, XXL |
| 47580 | AERO CHROME* A-Line Breathable Performance Surgical Gown with Towel, XL, X-Long |

## Technological Characteristic Comparison Table

| Attribute | Predicate Device<br>(AERO CHROME*<br>Breathable<br>Performance Surgical<br>Gown, K200522) | Subject Device –<br>AERO CHROME*<br>Select Breathable<br>Performance Surgical<br>Gowns, K210688 | Subject Device – AERO<br>CHROME* A-<br>Line Breathable<br>Performance Surgical<br>Gowns, K210688 | Comparison<br>Analysis |
|-------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------|
| FDA<br>Classification<br>Code | FYA | FYA | FYA | Identical |
| FDA Device<br>Classification | Class II | Class II | Class II | Identical |
| Common Device<br>Name | Surgical Gown | Surgical Gown | Surgical Gown | Identical |
| Trade Name | AERO CHROME*<br>Breathable<br>Performance Surgical<br>Gown | AERO CHROME*<br>Select Breathable<br>Performance Surgical<br>Gown | AERO CHROME* A-<br>Line Breathable<br>Performance Surgical<br>Gown | Similar |
| Indications for<br>Use | AERO CHROME*<br>Breathable<br>Performance Surgical<br>Gowns are sterile,<br>single use surgical<br>apparel intended to be<br>worn by healthcare<br>professionals | AERO CHROME*<br>Select Breathable<br>Performance Surgical<br>Gowns are sterile, single<br>use surgical apparel<br>intended to be worn by<br>healthcare professionals | AERO CHROME* A-<br>Line Breathable<br>Performance Surgical<br>Gowns are sterile, single<br>use surgical apparel<br>intended to be worn by<br>healthcare professionals | Identical |

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Image /page/7/Picture/0 description: The image shows the logos of two companies, Owens & Minor and Halyard. The Owens & Minor logo is on the left and consists of the letters "OM" in a bold, red font, with the words "Owens & Minor" in a smaller, gray font to the right. The Halyard logo is on the right and consists of a blue circle with a white and green arrow inside, followed by the word "HALYARD" in a bold, blue font.

| Attribute | Predicate Device<br>(AERO CHROME*<br>Breathable Performance<br>Surgical Gown, K200522) | Subject Device -<br>AERO CHROME*<br>Select Breathable<br>Performance Surgical<br>Gowns, K210688 | Subject Device – AERO<br>CHROME* A-<br>Line Breathable<br>Performance Surgical<br>Gowns, K210688 | Comparison<br>Analysis |
|----------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------|
| | to help protect both the<br>patient and the<br>healthcare worker from<br>the transfer of<br>microorganisms, body<br>fluids, and particulate<br>matter. The AERO<br>CHROME* Breathable<br>Performance Surgical<br>Gowns meet the Level 4<br>AAMI PB70 Liquid Barrier<br>classifications | to help protect both the<br>patient and the<br>healthcare worker from<br>the transfer of<br>microorganisms, body<br>fluids, and particulate<br>matter. The AERO<br>CHROME* Select<br>Breathable Performance<br>Surgical Gowns meet the<br>Level 4 AAMI PB70 Liquid<br>Barrier classifications. | to help protect both the<br>patient and the<br>healthcare worker from<br>the transfer of<br>microorganisms, body<br>fluids, and particulate<br>matter. The AERO<br>CHROME* A-Line<br>Breathable Performance<br>Surgical Gowns meet the<br>Level 4 AAMI PB70 Liquid<br>Barrier classifications. | |
| How the<br>Device is<br>Supplied | Sterile or Bulk Non-<br>Sterile | Sterile or Bulk Non-<br>Sterile | Sterile | Similar |
| Sterilizat<br>ion<br>Method | Ethylene Oxide | Ethylene Oxide | Ethylene Oxide | Identical |
| SAL | 10-6 | 10-6 | 10-6 | Identical |
| Gown Color | Grey | Grey | Grey | Identical |
| Shelf-Life | 5 years | 5 years | 5 years | Identical |
| Gown Sizes | Small, Large, X-Large, XX-<br>Large, XXX-Large, X-Long<br>XL, X-Long XXL | Large, X-Large, XX-<br>Large | X-Long XL | Similar |

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Image /page/8/Picture/0 description: The image contains two company logos. The first logo is for Owens & Minor, featuring the letters "OM" in a bold, maroon color with horizontal lines running through them, followed by the words "Owens & Minor" in a smaller, gray font. The second logo is for Halyard, consisting of a green and white abstract shape resembling a stylized "H" inside a blue circle, followed by the word "HALYARD" in a bold, blue font.

# K210688

| Con-<br>struction<br>Overview | The AERO CHROME*<br>Breathable Performance<br>Surgical Gown is<br>manufactured from a<br>moisture-vapor<br>breathable, non-woven<br>fabric using a polymer<br>blend of polypropylene<br>and plastomer. The front<br>body and sleeve fabric are<br>a three-layer film<br>laminate. This fabric is an<br>SMS/F/SMS design that is<br>adhesively bonded<br>together. The film itself is<br>a multi-layer<br>polypropylene/plastomer, | The AERO CHROME*<br>Select Breathable<br>Performance Surgical<br>Gown is manufactured<br>from a moisture-vapor<br>breathable, non-woven<br>fabric using a polymer<br>blend of polypropylene<br>and plastomer. The front<br>body and sleeve fabric<br>are a three-layer film<br>laminate. This fabric is an<br>SMS/F/SMS design that is<br>adhesively bonded<br>together. The film itself<br>is a multi-layer<br>polypropylene/plastomer, | The AERO CHROME*<br>A-Line Breathable<br>Performance Surgical<br>Gown is manufactured<br>from a moisture-vapor<br>breathable, non-woven<br>fabric using a polymer<br>blend of polypropylene<br>and plastomer. The front<br>body and sleeve fabric<br>are a three-layer film<br>laminate. This fabric is an<br>SMS/F/SMS design that is<br>adhesively bonded<br>together. The film itself<br>is a multi-layer<br>polypropylene/plastomer, | Select Gown<br>- Similar<br><br>A-Line<br>Gown -<br>Identical |
|-------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------|
|-------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------|

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Image /page/9/Picture/0 description: The image features the logos of two companies, Owens & Minor and Halyard. The Owens & Minor logo is on the left, with a stylized red emblem and the company name in gray text. To the right is the Halyard logo, which includes a blue circle with a green upward-pointing arrow inside, followed by the company name in bold, dark blue letters.

# K210688

| Attribute | Predicate Device<br>(AERO CHROME*<br>Breathable<br>Performance Surgical<br>Gown, K200522) | Subject Device –<br>AERO CHROME*<br>Select Breathable<br>Performance Surgical<br>Gowns, K210688 | Subject Device – AERO<br>CHROME* A-<br>Line Breathable<br>Performance Surgical<br>Gowns, K210688 | Comparison Analysis |
|------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------|
| | CaCO3 filled, grey film.<br>The polyolefin hot melt<br>adhesive is used to<br>laminate the facing layers<br>to the film layer to<br>complete the composite.<br>Sleeves of the gown are<br>closed with a heat-<br>sealing process to meet<br>AAMI-4 liquid barrier<br>requirements. The back<br>of the AERO CHROME*<br>Breathable Performance<br>Surgical Gown in the<br>non-critical zone is<br>composed of 1.2<br>osy SMS fabric with<br>an AAMI level 1<br>liquid barrier<br>protection. | CaCO3 filled, grey film.<br>The polyolefin hot melt<br>adhesive is used to<br>laminate the facing layers<br>to the film layer to<br>complete the composite.<br>Sleeves of the gown are<br>closed with a heat-<br>sealing process to meet<br>AAMI-4 liquid barrier<br>requirements. The<br>identical material that<br>comprises the front of<br>the gown also comprises<br>the back of the gown in<br>one continuous material.<br>Therefore, this gown<br>does not have side<br>seams. | CaCO3 filled, grey film.<br>The polyolefin hot melt<br>adhesive is used to<br>laminate the facing layers<br>to the film layer to<br>complete the composite.<br>Sleeves of the gown are<br>closed with a heat-<br>sealing process to meet<br>AAMI-4 liquid barrier<br>requirements. The back<br>of the AERO CHROME*<br>A-Line Breathable<br>Performance Surgical<br>Gown in the non-critical<br>zone is composed of 1.2<br>osy SMS fabric with an<br>AAMI level 1 liquid<br>barrier protection. | |
| Does not<br>contain<br>natural rubber<br>latex | Yes | Yes | Yes | Identical |

## Performance Testing

| Predicate Device -AERO CHROME* Breathable<br>Performance Surgical Gowns, K200522 | Subject Devices - AERO CHROME* Select<br>Breathable Performance Surgical Gowns<br>and AERO CHROME* A-Line Breathable<br>Performance Surgical Gowns, K210688 | Comparison<br>Analysis |
|---------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------|
| ANSI/AAMI PB70: 2012 Level 4 Liquid Barrier<br>Requirements for Critical Zone - Pass | ANSI/AAMI PB70: 2012 Level 4<br>Liquid Barrier Requirements for<br>Critical Zone - Pass | Identical |
| ANSI/AAMI PB70: 2012 Level 1 Liquid Barrier<br>Requirements for Non-Critical Zone<br>- Pass | ANSI/AAMI PB70: 2012 Level 1<br>Liquid Barrier Requirements for Non-<br>Critical Zone - Pass | Identical |
| Biocompatibility per ISO 10993 – Pass the<br>device under the conditions of the study is | Biocompatibility per ISO 10993 – Pass the<br>device under the conditions of the | Identical |

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Image /page/10/Picture/0 description: The image contains two company logos. On the left is the Owens & Minor logo, which features the letters "OM" in a bold, maroon font, with the words "Owens & Minor" in a smaller, gray font to the right. On the right is the Halyard logo, which features a green and white icon inside a blue circle, followed by the word "HALYARD" in a bold, blue font.

| Predicate Device -AERO CHROME* Breathable<br>Performance Surgical Gowns, K200522 | Subject Devices - AERO CHROME* Select<br>Breathable Performance Surgical Gowns<br>and AERO CHROME* A-Line Breathable<br>Performance Surgical Gowns, K210688 | Comparison Analysis |
|---------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------|
| non-cytotoxic, non-irritant, and non-sensitizing | study is non-cytotoxic, non-irritant, and non-sensitizing | |
| Water Vapor Transmission Rate of Materials<br>(MOCON) - Pass | Water Vapor Transmission Rate of<br>Materials (MOCON) - Pass | Identical |
| Linting per ISO 9073-10 - Pass | Linting per ISO 9073-10 - Pass | Identical |
| Standard Test Method for Breaking Strength and<br>Elongation of Textile Fabrics per ASTM D5034 -<br>Pass | Standard Test Method for Breaking<br>Strength and Elongation of Textile<br>Fabrics per ASTM D5034 - Pass | Identical |
| Peel Strength per STM-00197 - Pass | Peel Strength per STM-00197 - Pass | Identical |
| Hydrohead Testing - Pass | Hydrohead Testing - Pass | Identical |
| Abrasion Testing per STM-00149 - Pass | Abrasion Testing per STM-00149 -<br>Pass | Identical |
| 16 CFR, Chapter II - Consumer Product Safety<br>Commission Part 1610 - Standard for the<br>Flammability of Clothing Textiles Class 1 - Pass | 16 CFR, Chapter II - Consumer Product<br>Safety Commission Part 1610<br>- Standard for the Flammability of<br>Clothing Textiles Class 1 - Pass | Identical |
| Air Permeability (Back of Gown) per STM-<br>00162, NWSP 070.1.RO - Pass | Air Permeability (Back of Gown) per<br>STM-00162 - Pass | Similar |

## Summary of Non-Clinical Testing

| Standard/Reference | Test Method | Data Generated | Meets<br>Requirements |
|----------------------------|--------------------------------|------------------------------------------------------------------------------------------------|-----------------------|
| Liquid Barrier Performance | ANSI/AAMI<br>PB70:2012 Level 4 | Resistance to<br>Penetration by<br>Blood-Borne<br>Pathogens Using<br>Phi-X174<br>Bacteriophage | Pass |

{11}------------------------------------------------

Image /page/11/Picture/0 description: The image contains two company logos side by side. The first logo is for Owens & Minor, featuring the letters "OM" in a bold, maroon color with horizontal lines, accompanied by the company name in gray. The second logo is for Halyard, consisting of a blue circle with a stylized white and green shape inside, followed by the company name in bold, blue letters.

| Standard/Reference/ Test Method | Purpose | Acceptance Criteria | Results |
|------------------------------------------------------------------------------------|----------------------------------|----------------------------------------------------------------------|---------|
| Liquid Barrier Performance<br>ANSI/AAMI PB70:2012 Level 1 | Determine Water<br>Resistance | Meets standard<br>requirements for<br>Level<br>1 Liquid Barrier | Pass |
| Grab Tensile, Peak Stretch, and Peak<br>Energy - Nonwovens<br>ASTM D5034 - 9 2017 | Determine Tensile<br>Strength | Meets standard<br>requirements for<br>ASTM D5034 -9 2017 | Pass |
| Abrasion Resistance of<br>Nonwoven Fabrics<br>NWSP 020.5.RO (15) 2015 | Evaluate Abrasion<br>Resistance | Meets requirements<br>of standard NWSP<br>020.5.RO (15) 2015 | Pass |
| Synthetic Blood Penetration<br>ASTM F1670 (2017) | Resistance to<br>Penetration | Meets standard<br>requirements for<br>ASTM F1670<br>(2017) | Pass |
| Water Vapor Transmission Rate<br>NWSP 070.4.RO (15) 2015 | Water Vapor<br>Transmission | Meets standard<br>requirements for<br>NWSP 070.4.RO (15)<br>2015 | Pass |
| 180 Degree Peel Strength of Non-<br>Elastic Laminated Nonwovens<br>STM-00197 Rev 1 | Peel Strength | LSL:>125 grams | Pass |
| Linting ISO 9073-10 2003 | Particulate | Meets requirement<br>for ISO 9073-10 2003 | Pass |
| Standard for the Flammability for<br>Clothing Textiles16 CFR 1610 | Flammability | Meets Class 1<br>requirements | Pass |
| ISO L929 MEM Elution<br>Cytotoxicity ISO 10993-5:2009 | Cytotoxicity | < Grade 2 | Pass |
| ISO Indirect Primary Skin Irritation<br>Test ISO 10993-10:2010 | Irritation | (mild reactivity) | Pass |
| ISO Kligman Maximization Test ISO<br>10993-10:2010 | Sensitization | < 0.4 | Pass |
| EO Sterilization Residuals ISO 109937-<br>7:2008 (R) 2012 | EO Residuals | Meet EO Residual<br>requirements per<br>ISO 1099370 -<br>7:200(R) 12 | Pass |
| Laser Ignition Resistance ISO 11810-<br>1:2015 | Evaluate Laser<br>Induced Hazard | Class 1 rating<br>No ignition | Pass |

### Conclusion

The conclusion drawn from the nonclinical tests demonstrates that the subject devices in 510(k) submission K210688, the AERO CHROME* Select Breathable Performance Surgical Gown and AERO CHROME* A-Line Breathable Performance Surgical Gown, are as safe, as effective, and performs as well as or better than the legally marketed predicate device cleared under K200522.