AERO CHROME* Breathable Performance Surgical Gowns
Device Facts
| Record ID | K200522 |
|---|---|
| Device Name | AERO CHROME* Breathable Performance Surgical Gowns |
| Applicant | O&M Halyard, Inc. |
| Product Code | FYA · General, Plastic Surgery |
| Decision Date | Mar 16, 2020 |
| Decision | SESE |
| Submission Type | Abbreviated |
| Regulation | 21 CFR 878.4040 |
| Device Class | Class 2 |
Indications for 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 AAMI PB70:2012 Liquid Barrier classifications.
Device Story
AERO CHROME* Breathable Performance Surgical Gowns are single-use surgical apparel designed for healthcare professionals in clinical settings. The device features a multi-layer SMS/F/SMS (spunbond-meltblown-spunbond/film/spunbond-meltblown-spunbond) construction in the critical zone, providing AAMI Level 4 liquid barrier protection. The back of the gown uses 1.2 osy SMS fabric for breathability, meeting AAMI Level 1 liquid barrier standards. The film layer is a polypropylene/plastomer blend with CaCO3 filler to create micropores for vapor transmission. The gown is supplied sterile (via ethylene oxide) or as bulk non-sterile product. By providing a barrier against fluids and microorganisms, the gown helps reduce the risk of cross-contamination between patients and healthcare workers during surgical procedures.
Clinical Evidence
Bench testing only. Performance testing included AAMI PB70:2012 liquid barrier testing, ISO 10993 biocompatibility (cytotoxicity, irritation, sensitization), ASTM D5034 tensile strength, ISO 9073-10 linting, ASTM F1670 synthetic blood penetration, and flammability testing per 16 CFR 1610. All tests met requirements.
Technological Characteristics
Materials: SMS/F/SMS non-woven polymer blend (polypropylene/plastomer). Critical zone: AAMI Level 4 liquid barrier. Non-critical zone: 1.2 osy SMS fabric (AAMI Level 1). Sterilization: Ethylene Oxide (SAL 10^-6). Connectivity: None. Form factor: Various sizes (S to XXXL, X-Long). Standards: ANSI/AAMI PB70:2012, ISO 10993, ASTM D5034, ISO 9073-10, ASTM F1670, 16 CFR 1610.
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 CHROME* Breathable Performance Surgical Gowns (K153255)
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 a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
March 16, 2020
O&M Halyard, Inc Kimberly Lewis Sr. Manager, Regulatory Affairs 9120 Lockwood Blvd Mechanicsville, Virginia 23116
Re: K200522
Trade/Device Name: AERO CHROME* Breathable Performance Surgical Gowns Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical Apparel Regulatory Class: Class II Product Code: FY A Dated: February 28, 2020 Received: March 2, 2020
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 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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Elizabeth F. Claverie, MS 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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#### DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
## Indications for Use
510(k) Number (if known)
K200522
Device Name
AERO CHROME* Breathable Performance Surgical Gowns
#### Indications for Use (Describe)
The AERO CHROME* 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 microorganisms, body fluids, and particulate matter. The AERO CHROME* Breathable Performance Surgical Gowns meet the Level 4 AAMI PB70:2012 Liquid Barrier classifications.
| Non-Sterile Product Codes | | |
|---------------------------|------------------------------------------------------------------------------------------|------------------|
| Product Code | Device 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 | X-Large |
| 44665NS | AERO CHROME* Breathable Performance Surgical Gown, XL - Handi-Bin | X-Large |
| 44666NS | AERO CHROME* Breathable Performance Surgical Gown, XXL | XX-Large |
| 44667NS | AERO CHROME* Breathable Performance Surgical Gown, L, X-Long | Large, X-Long |
| 44668NS | AERO CHROME* Breathable Performance Surgical Gown, XL, X-Long | X-Large, X-Long |
| 44669NS | AERO CHROME* Breathable Performance Surgical Gown, XXL, X-Long | XX-Large, X-Long |
| 44670NS | AERO CHROME* Breathable Performance Surgical Gown with Towel in Overwrap, L - Handi-Bin | Large |
| 44671NS | AERO CHROME* Breathable Performance Surgical Gown with Towel in Overwrap, XL - Handi-Bin | X-Large |
| Sterile Product Codes | | |
| Product Code | Device Description | Gown Size |
| 44672 | AERO CHROME* Breathable Performance Surgical Gown with Towel, S | Small |
| 44673 | AERO CHROME* Breathable Performance Surgical Gown with Towel, L | Large |
| 44674 | AERO CHROME* Breathable Performance Surgical Gown with Towel, XL | X-Large |
| 44675 | AERO CHROME* Breathable Performance Surgical Gown with Towel, XXL | XX-Large |
| 44676 | AERO CHROME* Breathable Performance Surgical Gown with Towel, XXXL | XXX-Large |
| 44677 | AERO CHROME* Breathable Performance Surgical Gown with Towel, L, X-Long | Large, X-Long |
| 44678 | AERO CHROME* Breathable Performance Surgical Gown with Towel, XL, X-Long | X-Large, X-Long |
| 44679 | AERO CHROME* Breathable Performance Surgical Gown with Towel, XXL, X-Long | XX-Large, X-Long |
XX-Large, X-Long
Type of Use (Select one or both, as applicable)
X-Long
_ Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
Form Approved: OMB No. 0910-0120
Expiration Date: 06/30/2020
See PRA Statement below.
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Image /page/4/Picture/0 description: The image shows two company logos side by side. On the left is the Owens & Minor logo, 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. To the right is the Halyard logo, which includes a stylized green and white mountain peak inside a dark blue circle, followed by the word "HALYARD" in a bold, dark blue font.
## 510(k) Summary
| 510(k) Number: | K200522 |
|----------------------------|--------------------------------------------------------------------------------------------------------------------------|
| Date Prepared: | February 28, 2020 |
| 510(k) Sponsor: | O&M Halyard Inc.<br>9120 Lockwood Boulevard<br>Mechanicsville, VA 23116 |
| Regulatory Contact: | Kimberly Lewis<br>5405 Windward Pkwy<br>3rd Floor West<br>Alpharetta, GA 30004<br>470-280-4388<br>Kimberly.lewis@hyh.com |
| Device Trade Name: | AERO CHROME* Breathable Performance Surgical Gowns |
| Device Common Name: | Surgical Gown |
| FDA Device Product Code: | FYA |
| FDA Device Classification: | Class II |
| FDA Device Name: | Gown, Surgical |
| FDA Regulation Number: | 21 CFR 878.4040 |
| Predicate Device: | K153255 – AERO CHROME* Breathable Performance Surgical<br>Gowns |
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Image /page/5/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 horizontal lines running through them, followed by the words "Owens & Minor" in a smaller, gray font. On the right is the Halyard logo, which consists of a green and white upward-pointing arrow inside a blue circle, followed by the word "HALYARD" in a bold, blue font.
# Device
| Description: | The AERO CHROME* Breathable Performance Surgical Gowns have a SMS/F/SMS design (Spunbond-Meltblown- Spunbond/Film/Spunbond-Meltblown-Spunbond) that provides a PB70:2012 Level 4 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 CHROME* Breathable 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 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 AAMI PB70:2012 Liquid Barrier classifications.
## Product Codes Subject to this Premarket Notification
| Product Code | Device Description |
|--------------|---------------------------------------------------------------------------------|
| 44661NS | AERO CHROME* Breathable Performance Surgical Gown, S (Non-Sterile) |
| 44662NS | AERO CHROME* Breathable Performance Surgical Gown, L (Non-Sterile) |
| 44663NS | AERO CHROME* Breathable Performance Surgical Gown, L - Handi-Bin (Non-Sterile) |
| 44664NS | AERO CHROME* Breathable Performance Surgical Gown, XL (Non-Sterile) |
| 44665NS | AERO CHROME* Breathable Performance Surgical Gown, XL - Handi-Bin (Non-Sterile) |
| 44666NS | AERO CHROME* Breathable Performance Surgical Gown, XXL (Non-Sterile) |
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Image /page/6/Picture/0 description: The image shows two company logos side by side. On the left is the Owens & Minor logo, 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. To the right is the Halyard logo, which includes a stylized green and white icon resembling a sail or a stylized "H", accompanied by the word "HALYARD" in a bold, dark blue font.
| 44667NS | AERO CHROME* Breathable Performance Surgical Gown, L, X-Long (Non-Sterile) |
|---------|--------------------------------------------------------------------------------------------------------|
| 44668NS | AERO CHROME* Breathable Performance Surgical Gown, XL, X-Long (Non-Sterile) |
| 44669NS | AERO CHROME* Breathable Performance Surgical Gown, XXL, X-Long (Non-Sterile) |
| 44670NS | AERO CHROME* Breathable Performance Surgical Gown with Towel in Overwrap, L - Handi-Bin (Non-Sterile) |
| 44671NS | AERO CHROME* Breathable Performance Surgical Gown with Towel in Overwrap, XL - Handi-Bin (Non-Sterile) |
| 44672 | AERO CHROME* Breathable Performance Surgical Gown with Towel, S |
| 44673 | AERO CHROME* Breathable Performance Surgical Gown with Towel, L |
| 44674 | AERO CHROME* Breathable Performance Surgical Gown with Towel, XL |
| 44675 | AERO CHROME* Breathable Performance Surgical Gown with Towel, XXL |
| 44676 | AERO CHROME* Breathable Performance Surgical Gown with Towel, XXXL |
| 44677 | AERO CHROME* Breathable Performance Surgical Gown with Towel, L, X-Long |
| 44678 | AERO CHROME* Breathable Performance Surgical Gown with Towel, XL, X-Long |
| 44679 | AERO CHROME* Breathable Performance Surgical Gown with Towel, XXL, X-Long |
# Technological Characteristic Comparison Table
| Attribute | Predicate Device (AERO<br>CHROME* Breathable<br>Performance Surgical<br>Gown, K153255) | Subject Device | Comparison<br>Analysis |
|--------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------|
| FDA<br>Classification<br>Code | FYA | FYA | Identical |
| FDA Device<br>Classification | Class II | Class II | Identical |
| Attribute | Predicate Device (AERO<br>CHROME* Breathable<br>Performance Surgical<br>Gown, K153255) | Subject Device | Comparison<br>Analysis |
| Common<br>Device Name | Surgical Gown | Surgical Gown | Identical |
| Trade Name | AERO CHROME*<br>Breathable Performance<br>Surgical Gown | AERO CHROME*<br>Breathable Performance<br>Surgical Gown | Identical |
| Indications for<br>Use | AERO CHROME*<br>Breathable Performance<br>Surgical Gowns are<br>sterile, single use surgical<br>apparel intended to be<br>worn by healthcare<br>professionals to help<br>protect both the patient<br>and the healthcare worker<br>from the transfer of<br>microorganisms, body<br>fluids, and particulate<br>matter.<br><br>The AERO CHROME*<br>Breathable Performance<br>Surgical Gowns meet the<br>Level 4 AAMI PB70<br>Liquid Barrier<br>classifications | AERO CHROME*<br>Breathable Performance<br>Surgical Gowns are<br>sterile, single use surgical<br>apparel intended to be<br>worn by healthcare<br>professionals to help<br>protect both the patient<br>and the healthcare worker<br>from the transfer of<br>microorganisms, body<br>fluids, and particulate<br>matter.<br><br>The AERO CHROME*<br>Breathable Performance<br>Surgical Gowns meet the<br>Level 4 AAMI PB70<br>Liquid Barrier<br>classifications. | Identical |
| How the Device<br>is Supplied | Sterile or Bulk Non-<br>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,<br>X-Long XL, X-Long XXL | Small, Large, X-Large,<br>XX-Large, XXX-Large,<br>X-Long XL, X-Long XXL | Identical |
| Construction<br>Overview | The AERO CHROME*<br>Breathable Performance<br>Surgical Gown is<br>manufactured from a<br>moisture-vapor<br>breathable, repellent, non- | The AERO CHROME*<br>Breathable Performance<br>Surgical Gown is<br>manufactured from a<br>moisture-vapor<br>breathable, non-woven | Similar |
| Attribute | Predicate Device (AERO<br>CHROME* Breathable<br>Performance Surgical<br>Gown, K153255) | Subject Device | Comparison<br>Analysis |
| | polymer blend of<br>polypropylene and<br>polyethylene. The front<br>body and sleeve fabric are<br>a three- layer film<br>laminate. This fabric is an<br>S/F/SMS design that is<br>adhesively bonded<br>together. The film itself is<br>a multi-layer<br>polypropylene-based<br>vapor breathable<br>membrane that uses<br>CaCO3 filler to create<br>micropores to allow vapor<br>transmission across the<br>membrane. The<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 of the gown are<br>closed with a heat-sealing<br>process to meet AAMI-4<br>liquid barrier<br>requirements. The back<br>of the AERO CHROME*<br>Breathable Performance<br>Surgical Gown in the non-<br>critical zone is composed<br>of 1.2 osy SMS fabric<br>with an AAMI level 1<br>liquid barrier protection.<br>The gown film layer is<br>treated with a<br>fluorochemical. | 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,<br>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-sealing<br>process to meet AAMI-4<br>liquid barrier<br>requirements. The back<br>of the AERO CHROME*<br>Breathable Performance<br>Surgical Gown in the non-<br>critical zone is composed<br>of 1.2 osy SMS fabric<br>with an AAMI level 1<br>liquid barrier protection. | |
| Does not<br>contain natural<br>rubber latex | Yes | Yes | Identical |
| Predicate Device (AERO<br>CHROME* Breathable<br>Performance Surgical Gowns,<br>K153255) | Subject Device | Comparison<br>Analysis | |
| ANSI/AAMI PB70: 2012 Level 4<br>Liquid Barrier Requirements for<br>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<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 conditions<br>of the study is non-cytotoxic, non-<br>irritant, and non-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 - 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 Flammability<br>of Clothing Textiles 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) per<br>STM-00162. NWSP 070.1.RO - Pass | Air Permeability (Back of Gown)<br>per STM-00162 - Pass | Similar | |
| Standard/Reference | Test Method | Data Generated | Meets<br>Requirements |
| 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 4 | Water Resistance | Pass |
| Spray Impact (Non-Critical<br>Zones) | AATCC 42 | Water Resistance…
