Aero Blue Performance Surgical Gowns

K192362 · O&M Halyard, Inc. · FYA · Dec 13, 2019 · General, Plastic Surgery

Device Facts

• Record ID: K192362
• Device Name: Aero Blue Performance Surgical Gowns
• Applicant: O&M Halyard, Inc.
• Product Code: FYA · General, Plastic Surgery
• Decision Date: Dec 13, 2019
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 878.4040
• Device Class: Class 2

Intended Use

The Aero Blue 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 Blue Performance Surgical Gowns meet the Level 3 AAMI PB70:2012 Liquid Barrier classifications.

Device Story

Aero Blue Performance Surgical Gowns are single-use, sterile or non-sterile surgical apparel. Constructed from a moisture-vapor breathable, non-woven polymer blend (polypropylene and plastomer). Critical zones utilize a three-layer SMS/F/SMS (Spunbond-Meltblown-Spunbond/Film/Spunbond-Meltblown-Spunbond) laminate; film layer is a multi-layer polyethylene-based membrane with calcium carbonate filler for microporous vapor transmission. Non-critical back zone uses breathable SMS fabric. Sleeves are heat-sealed. Gowns provide AAMI PB70:2012 Level 3 liquid barrier protection in critical zones and Level 1 in non-critical zones. Used in surgical settings by healthcare professionals to prevent cross-contamination of microorganisms, body fluids, and particulates between patient and staff.

Clinical Evidence

Bench testing only. No clinical data. Performance verified via AAMI PB70:2012 liquid barrier testing, ISO 10993 biocompatibility (cytotoxicity, irritation, sensitization), ASTM D5034 tensile strength, ASTM F1670 synthetic blood penetration, ISO 9073-10 linting, and 16 CFR 1610 flammability testing.

Technological Characteristics

Materials: Polypropylene and plastomer non-woven blend; three-layer SMS/F/SMS laminate in critical zones; SMS in back. Standards: AAMI PB70:2012 (Level 3 critical/Level 1 non-critical), ISO 10993 (biocompatibility), ASTM D5034 (tensile), ASTM F1670 (blood penetration), ISO 9073-10 (linting), 16 CFR 1610 (flammability). Sterilization: Ethylene Oxide (SAL 10^-6). Form factor: Various sizes (S to XXXL, X-Long).

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. No specific age or gender restrictions; contraindications not stated.

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 Gowns (K140539)

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 & 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, followed by the words "U.S. FOOD & DRUG ADMINISTRATION".

December 13, 2019

O&M Halyard, Inc. Kimberly Lewis Senior Manager, Regulatory Affairs 9120 Lockwood Blvd Mechanicsville, Virginia 23116

Re: K192362

Trade/Device Name: Aero Blue Performance Surgical Gowns Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical apparel Regulatory Class: Class II Product Code: FYA Dated: August 29, 2019 Received: August 30, 2019

Dear Kimberly Lewis:

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

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542 of the Act); 21 CFR 1000-1050.

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 801and Part 809; 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 (QS) 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-

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 medical devices and radiation-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,

Elizabeth F. Claverie-Williams, MS Assistant Director. THT4B2: Disinfection Reprocessing and Personal Protection 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)

#### K192362

#### Device Name

Aero Blue Performance Surgical Gowns

#### Indications for Use (Describe)

The Aero Blue Performance Surgical gowns are steile, single use surgical apparel intended to be worn by healthcare professionals to help protect both the healthcate worker from the transfer of microorganisms, body fluuds, and particulate matter. The Aero Blue Performance Surgical Gowns meet the Level 3 AAMI PB70:2012 Liqud Barier classifications.

Non-Sterile Product Codes

| Product Code | Device Description | Gown Size |
|-----------------------|----------------------------------------------------------------|------------------|
| 41722NS | Aero Blue Performance Surgical Gown with Towel in Overwrap, L | Large |
| 41723NS | Aero Blue Performance Surgical Gown with Towel in Overwrap, XL | X-Large |
| 41725NS | Aero Blue Performance Surgical Gown, X-Long, L | X-Long, Large |
| 41727NS | Aero Blue Performance Surgical Gown, X-Long, XL | X-Long, X-Large |
| 41737NS | Aero Blue Performance Surgical Gown, L | Large |
| 41738NS | Aero Blue Performance Surgical Gown, XL | X-Large |
| 41739NS | Aero Blue Performance Surgical Gown, L | Large |
| 41740NS | Aero Blue Performance Surgical Gown, XL | X-Large |
| 41741NS | Aero Blue Performance Surgical Gown, XXL | XX-Large |
| 43623NS | Aero Blue Performance Surgical Gown, XXL, X-Long | X-Long, XX-Large |
| 43941NS | Aero Blue Performance Surgical Gown, S | Small |
| Sterile Product Codes | | |
| Product Code | Device Description | Gown Size |
| 41724 | Aero Blue Performance Surgical Gown, X-Long, L | X-Long, Large |
| 41726 | Aero Blue Performance Surgical Gown, X-Long, XL | X-Long, X-Large |
| 41732 | Aero Blue Performance Surgical Gown, S | Small |
| 41733 | Aero Blue Performance Surgical Gown, L | Large |
| 41734 | Aero Blue Performance Surgical Gown, XL | X-Large |
| 41735 | Aero Blue Performance Surgical Gown, XXL | XX-Large |
| 41736 | Aero Blue Performance Surgical Gown, XXXL | XXX-Large |
| 43938 | Aero Blue Performance Surgical Gown with Towel, X-Long, XXL | X-Long, XX-Large |
| | | |

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

] Prescription Use (Part 21 CFR 801 Subpart D)

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

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Image /page/4/Picture/0 description: The image features two company logos side-by-side. On the left is the Owens & Minor logo, with a stylized "OM" in maroon and the company name in gray. To the right is the Halyard logo, which includes a green and white symbol resembling a stylized sail or upward-pointing arrow within a dark blue circle, followed by the company name "HALYARD" in dark blue, bold sans-serif font. The logos are positioned horizontally, suggesting a partnership or comparison between the two companies.

# 510(k) Summary

| 510(k)<br>Number: | K192362 |
|-------------------------------|--------------------------------------------------------------------------------------------------------------------------|
| Date<br>Prepared: | November 19, 2019 |
| 510(k)<br>Sponsor: | O&M Halyard Inc.<br>9120 Lockwood Boulevard<br>Mechanicsville, VA 23116 |
| Regulatory<br>Contact: | Kimberly Lewis<br>5405 Windward Pkwy<br>3rd Floor West<br>Alpharetta, GA 30004<br>470-280-4388<br>[e-mail] |
| Device Trade<br>Name: | Aero Blue 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<br>Device: | K140539 - Aero Blue Performance Surgical Gowns |
| Device<br>Description: | The Aero Blue Performance Surgical Gowns have a SMS/F/SMS<br>design (Spunbond-Meltblown-Spunbond/Film/Spunbond- |

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Image /page/5/Picture/0 description: The image shows the logos of two companies, Owens & Minor and Halyard Health. The Owens & Minor logo is on the left and features the company's initials in a stylized font, with the full name written out to the right. The Halyard Health logo is on the right and features a green and blue icon next to the company name in blue.

Meltblown-Spunbond) that provides a PB70:2012 Level 3 Liquid Barrier Performance Barrier in the critical zone. The back of the gown has a Spundbond-Meltblown-Spunbond (SMS) fabric which allows for air-breathability with an AAMI Level 1 Liquid Barrier Performance Barrier.

The Aero Blue Performance Surgical Gown is a single use gown, supplied sterile (via Ethylene Oxide) or as bulk non-sterile product. The gowns come in the following various sizes: Small, Large, X-Large, XX-Large, XXX-Large, X-Long XL, X-Long XXL.

### Indications for

Use:

The Aero Blue 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 Blue Performance Surgical Gowns meet the Level 3 AAMI PB70:2012 Liquid Barrier classifications.

| Product<br>Code | Device Description | Gown Size |
|---------------------|-------------------------------------------------------------------|-----------------|
| Non-Sterile Product | | |
| 41722NS | Aero Blue Performance Surgical Gown with<br>Towel in Overwrap, L | Large |
| 41723NS | Aero Blue Performance Surgical Gown with<br>Towel in Overwrap, XL | X-Large |
| 41725NS | Aero Blue Performance Surgical Gown, X-Long,<br>L | Large, X-Long |
| 41727NS | Aero Blue Performance Surgical Gown, X-Long,<br>XL | X-Large, X-Long |
| 41737NS | Aero Blue Performance Surgical Gown, L | Large |
| 41738NS | Aero Blue Performance Surgical Gown, XL | X-Large |
| 41739NS | Aero Blue Performance Surgical Gown, L | Large |
| 41740NS | Aero Blue Performance Surgical Gown, XL | X-Large |

### Product Codes Subject to this Premarket Notification

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Image /page/6/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 maroon emblem and the company name in gray. The Halyard logo is on the right, with a green and blue emblem and the company name in blue. The logos are placed side by side.

| 41741NS | Aero Blue Performance Surgical Gown, XXL | XX-Large |
|-----------------|----------------------------------------------------------------|-------------------|
| 43623NS | Aero Blue Performance Surgical Gown, XXL, X-<br>Long | XXX-Large, X-Long |
| 43941NS | Aero Blue Performance Surgical Gown, S | Small |
| Sterile Product | | |
| 41724 | Aero Blue Performance Surgical Gown, X-Long,<br>L | Large |
| 41726 | Aero Blue Performance Surgical Gown, X-Long,<br>XL | X-Large, X-Long |
| 41732 | Aero Blue Performance Surgical Gown, S | Small |
| 41733 | Aero Blue Performance Surgical Gown, L | Large |
| 41734 | Aero Blue Performance Surgical Gown, XL | X-Large |
| 41735 | Aero Blue Performance Surgical Gown, XXL | XX-Large |
| 41736 | Aero Blue Performance Surgical Gown, XXXL | XXX-Large |
| 43938 | Aero Blue Performance Surgical Gown with<br>Towel, X-Long, XXL | XX-Large, X-Long |

# Technological Characteristic Comparison Table

| Attribute | Predicate Device (Aero<br>Blue Performance<br>Surgical Gowns,<br>K140539) | Subject Device -<br>K192362 | Comparison<br>Analysis |
|------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------|
| FDA<br>Classification<br>Code | FYA | FYA | Identical |
| FDA Device<br>Classification | Class II | Class II | Identical |
| Common<br>Device Name | Surgical Gown | Surgical Gown | Identical |
| Trade Name | Aero Blue Performance<br>Surgical Gowns | Aero Blue Performance<br>Surgical Gowns | Identical |
| Indications for<br>Use | Aero Blue Performance<br>Surgical Gowns are sterile,<br>single use surgical apparel<br>intended to be worn by | Aero Blue Performance<br>Surgical Gowns are<br>sterile, single use surgical<br>apparel intended to be | Similar |
| Attribute | Predicate Device (Aero<br>Blue Performance<br>Surgical Gowns,<br>K140539) | Subject Device -<br>K192362 | Comparison<br>Analysis |
| | healthcare professionals to<br>help protect both the<br>patient and the healthcare<br>worker from the transfer of<br>microorganisms, body<br>fluids, and particulate<br>matter.<br><br>The Aero Blue<br>Performance Surgical<br>Gowns meet the Level 3<br>AAMI PB70:2012 Liquid<br>Barrier classifications.<br><br>The Aero Blue<br>Performance Surgical<br>Gowns are also sold as<br>bulk, non-sterile, single use<br>items to<br>repackager/relabeler,<br>establishments for further<br>packaging and Ethylene<br>Oxide (EO) sterilization. | worn by healthcare<br>professionals to help<br>protect both the patient<br>and the healthcare<br>worker from the transfer<br>of microorganisms, body<br>fluids, and particulate<br>matter.<br><br>The Aero Blue<br>Performance Surgical<br>Gowns meet the Level 3<br>AAMI PB70:2012 Liquid<br>Barrier classifications. | |
| How the Device<br>is Supplied | Sterile or Bulk Non-Sterile | Sterile or Bulk Non-<br>Sterile | Identical |
| Sterilization<br>Method | Ethylene Oxide | Ethylene Oxide | Identical |
| SAL | 10-6 | 10-6 | Identical |
| Gown Color | Blue | Blue | Identical |
| Gown Sizes | Small, Large, X-Large,<br>XX-Large, XXX-Large | Small, Large, X-Large,<br>XX-Large, XXX-Large,<br>X-Long XL, X-Long<br>XXL | Similar |
| Construction<br>Overview | The Aero Blue<br>Performance Surgical<br>Gown is manufactured<br>from a moisture-vapor<br>breathable, repellent, non-<br>woven fabric using a<br>polymer blend of<br>polypropylene and<br>polyethylene. The front | The Aero Blue<br>Performance Surgical<br>Gown is manufactured<br>from a moisture-vapor<br>breathable, transmitting,<br>non-woven fabric using a<br>polymer blend of<br>polypropylene and<br>plastomer. The front | Similar |
| Attribute | Predicate Device (Aero<br>Blue Performance<br>Surgical Gowns, K140539) | Subject Device -<br>K192362 | Comparison<br>Analysis |
| | body and sleeve fabric is a<br>three layer film laminate.<br>This fabric is an SFSMS<br>design<br>(Spunbond/Film/Spunbond<br>-Meltblown-Spunbond)<br>that is adhesively bonded<br>together. The film itself is<br>a multi-layer<br>polypropylene-based vapor<br>breathable membrane that<br>uses Calcium Carbonate<br>(CaCO3) filler to create<br>micropores to allow vapor<br>transmission across the<br>membrane. A polyolefin<br>hot melt adhesive is used to<br>laminate the facing layers<br>to the film layer to<br>complete the composite.<br>Sleeves in the gown are<br>closed with a heat sealing<br>process to meet AAMI-3<br>liquid barrier requirements.<br>The back of the gown (in<br>the non-critical zone) is<br>composed of a breathable<br>SMS fabric with an AAMI<br>1 liquid barrier protection. | body and sleeve fabric<br>are a three layer film<br>laminate. This fabric is<br>an SMS/F/SMS design<br>(Spunbond-Meltblown-<br>Spunbond/Film/Spunbon<br>d-Meltblown-Spunbond)<br>that is adhesively bonded<br>together. The film itself<br>is a multi-layer<br>polyethylene-based vapor<br>breathable membrane<br>that uses Calcium<br>Carbonate (CaCO3) filler<br>to create micropores to<br>allow vapor transmission<br>across the membrane. A<br>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 in the gown are<br>closed with a heat sealing<br>process to meet AAMI-3<br>liquid barrier<br>requirements. The back<br>of the gown (in the non-<br>critical zone) is<br>composed of a breathable<br>SMS fabric with an<br>AAMI 1 liquid barrier<br>protection. | |
| Does not<br>contain natural<br>rubber latex | Yes | Yes | Identical |
| Predicate Device (Aero Blue<br>Performance Surgical Gowns,<br>K140539) | Subject Device | Comparison<br>Analysis | |
| ANSI/AAMI PB70: 2012 Level 3<br>Liquid Barrier Requirements for<br>Critical Zone - Pass | ANSI/AAMI PB70: 2012 Level 3<br>Liquid Barrier Requirements for<br>Critical Zone - Pass | Identical | |
| ANSI/AAMI PB70: 2012 Level 1<br>Liquid Barrier Requirements for<br>Non-Critical Zone - Pass | ANSI/AAMI PB70: 2012 Level 1<br>Liquid Barrier Requirements for<br>Non-Critical Zone - Pass | Identical | |
| Biocompatibility per ISO 10993 –<br>Pass the device under the<br>conditions of the study is non-<br>cytotoxic, non-irritant, and non-<br>sensitizing | Biocompatibility per ISO 10993 –<br>Pass the device under the<br>conditions of the study is non-<br>cytotoxic, non-irritant, and non-<br>sensitizing | Identical | |
| Water Vapor Transmission Rate of<br>Materials (MOCON) - Pass | Water Vapor Transmission Rate of<br>Materials (MOCON) - Pass | Similar | |
| Linting per ISO 9073-10 - Pass | Linting per ISO 9073-10 - Pass | Similar | |
| Standard Test Method for Breaking<br>Strength and Elongation of Textile<br>Fabrics per ASTM D5034 - Pass | Standard Test Method for<br>Breaking Strength and Elongation<br>of Textile Fabrics per ASTM<br>D5034 - Pass | Similar | |
| Peel Strength per STM-00197 -<br>Pass | Peel Strength per STM-00197 -<br>Pass | Similar | |
| Hydrohead Testing – Pass | Hydrohead Testing – Pass | Similar | |
| Abrasion Testing per STM-00149 -<br>Pass | Abrasion Testing per STM-00149 -<br>Pass | Similar | |
| 16 CFR, Chapter II – Consumer<br>Product Safety Commission Part<br>1610 – Standard for the<br>Flammability of Clothing Textiles<br>Class 1 - Pass | 16 CFR, Chapter II – Consumer<br>Product Safety Commission Part<br>1610 – Standard for the<br>Flammability of Clothing Textiles<br>Class 1 - Pass | Identical | |
| Air Permeability (Back of Gown)<br>per STM-00162, NWSP 070.1.RO -<br>Pass | Air Permeability (Back of Gown)<br>per STM-00162 - Pass | Similar | |
| Test Method/Reference | Acceptance<br>Criteria | Results | |
| Spray Impact (Critical<br>Zones) | AATCC 42 | Water Resistance | Pass |
| Hydrostatic Pressure<br>(Critical Zones) | AATCC 127 | Water Resistance | Pass |
| Liquid Barrier Performance | ANSI/AAMI<br>PB70:2012 Level 3 | Water Resistance | Pass |
| Spray Impact (Non-Critical<br>Zones) | AATCC 42 | Water Resistance | Pass |
| Liquid Barrier Performance | ANSI/AAMI<br>PB70:2012 Level 1…