(14 days)
Not Found
No
The device description and performance studies focus solely on the material properties and barrier performance of surgical gowns, with no mention of AI or ML technologies.
No
This device is a surgical gown, which is a protective barrier for healthcare professionals and patients, not a device used for therapy or treatment.
No
This device is a surgical gown, which is a protective apparel and not used for diagnosing medical conditions.
No
The device is a physical surgical gown made of fabric, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the gowns are for protecting healthcare professionals and patients from the transfer of microorganisms, body fluids, and particulate matter. This is a barrier function, not a diagnostic function.
- Device Description: The description focuses on the materials and construction of the gown for barrier protection. There is no mention of analyzing samples from the human body or providing diagnostic information.
- Lack of IVD Characteristics: IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. This device does none of that.
The AERO CHROME* Breathable Performance Surgical Gowns are classified as surgical apparel or personal protective equipment (PPE).
N/A
Intended Use / Indications for Use
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.
Product codes (comma separated list FDA assigned to the subject device)
FYA
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
healthcare professionals
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Testing conducted to support the changes of the subject device shows that the AERO CHROME* Breathable Performance Surgical Gown is similar to the predicate device AERO CHROME* Breathable Performance Surgical Gown (K153255) in design, intended use, sterility, and technological characteristics. In the critical zone, the AERO CHROME* Breathable Performance Surgical Gowns meet the Level 4 AAMI PB70:2012 Liquid Barrier classification. The back of the gown meets the Level 1 AAMI PB70:2012 Liquid Barrier classification.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 878.4040 Surgical apparel.
(a)
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.(b)
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.
0
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
1
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)
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. |
| 9120 Lockwood Boulevard | |
| Mechanicsville, VA 23116 | |
| Regulatory Contact: | Kimberly Lewis |
| 5405 Windward Pkwy | |
| 3rd Floor West | |
| Alpharetta, GA 30004 | |
| 470-280-4388 | |
| 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 |
| 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
CHROME* Breathable
Performance Surgical
Gown, K153255) | Subject Device | Comparison
Analysis |
|--------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------|
| FDA
Classification
Code | FYA | FYA | Identical |
| FDA Device
Classification | Class II | Class II | Identical |
| Attribute | Predicate Device (AERO
CHROME* Breathable
Performance Surgical
Gown, K153255) | Subject Device | Comparison
Analysis |
| Common
Device Name | Surgical Gown | Surgical Gown | Identical |
| Trade Name | AERO CHROME*
Breathable Performance
Surgical Gown | AERO CHROME*
Breathable Performance
Surgical Gown | Identical |
| Indications for
Use | 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
Liquid Barrier
classifications | 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
Liquid Barrier
classifications. | Identical |
| How the Device
is Supplied | Sterile or Bulk Non-
Sterile | Sterile or Bulk Non-
Sterile | Identical |
| Sterilization
Method | Ethylene Oxide | Ethylene Oxide | Identical |
| SAL | 10-6 | 10-6 | Identical |
| Gown Color | Blue | Blue | Identical |
| Gown Sizes | Small, Large, X-Large,
XX-Large, XXX-Large,
X-Long XL, X-Long XXL | Small, Large, X-Large,
XX-Large, XXX-Large,
X-Long XL, X-Long XXL | Identical |
| Construction
Overview | The AERO CHROME*
Breathable Performance
Surgical Gown is
manufactured from a
moisture-vapor
breathable, repellent, non- | The AERO CHROME*
Breathable Performance
Surgical Gown is
manufactured from a
moisture-vapor
breathable, non-woven | Similar |
| Attribute | Predicate Device (AERO
CHROME* Breathable
Performance Surgical
Gown, K153255) | Subject Device | Comparison
Analysis |
| | polymer blend of
polypropylene and
polyethylene. The front
body and sleeve fabric are
a three- layer film
laminate. This fabric is an
S/F/SMS design that is
adhesively bonded
together. The film itself is
a multi-layer
polypropylene-based
vapor breathable
membrane that uses
CaCO3 filler to create
micropores to allow vapor
transmission across the
membrane. The
polyolefin hot melt
adhesive is used to
laminate the facing layers
to the film layer to
complete the composite.
Sleeves of the gown are
closed with a heat-sealing
process to meet AAMI-4
liquid barrier
requirements. The back
of the AERO CHROME*
Breathable Performance
Surgical Gown in the non-
critical zone is composed
of 1.2 osy SMS fabric
with an AAMI level 1
liquid barrier protection.
The gown film layer is
treated with a
fluorochemical. | blend of polypropylene
and plastomer. The front
body and sleeve fabric are
a three-layer film
laminate. This fabric is an
SMS/F/SMS design that is
adhesively bonded
together. The film itself is
a multi-layer
polypropylene/plastomer,
CaCO3 filled, grey film.
The polyolefin hot melt
adhesive is used to
laminate the facing layers
to the film layer to
complete the composite.
Sleeves of the gown are
closed with a heat-sealing
process to meet AAMI-4
liquid barrier
requirements. The back
of the AERO CHROME*
Breathable Performance
Surgical Gown in the non-
critical zone is composed
of 1.2 osy SMS fabric
with an AAMI level 1
liquid barrier protection. | |
| Does not
contain natural
rubber latex | Yes | Yes | Identical |
| Predicate Device (AERO
CHROME* Breathable
Performance Surgical Gowns,
K153255) | Subject Device | Comparison
Analysis | |
| ANSI/AAMI PB70: 2012 Level 4
Liquid Barrier Requirements for
Critical Zone - Pass | ANSI/AAMI PB70: 2012 Level 4
Liquid Barrier Requirements for
Critical Zone - Pass | Identical | |
| ANSI/AAMI PB70: 2012 Level 1
Liquid Barrier Requirements for
Non-Critical Zone - Pass | ANSI/AAMI PB70: 2012 Level 1
Liquid Barrier Requirements for
Non-Critical Zone - Pass | Identical | |
| Biocompatibility per ISO 10993 –
Pass the device under the conditions
of the study is non-cytotoxic, non-
irritant, and non-sensitizing | Biocompatibility per ISO 10993 –
Pass the device under the
conditions of the study is non-
cytotoxic, non-irritant, and non-
sensitizing | Identical | |
| Water Vapor Transmission Rate of
Materials (MOCON) - Pass | Water Vapor Transmission Rate of
Materials (MOCON) - Pass | Similar | |
| Linting per ISO 9073-10 - Pass | Linting per ISO 9073-10 - Pass | Similar | |
| Standard Test Method for Breaking
Strength and Elongation of Textile
Fabrics per ASTM D5034 - Pass | Standard Test Method for
Breaking Strength and Elongation
of Textile Fabrics per ASTM
D5034 - Pass | Similar | |
| Peel Strength per STM-00197 - Pass | Peel Strength per STM-00197 -
Pass | Similar | |
| Hydrohead Testing - Pass | Hydrohead Testing – Pass | Similar | |
| Abrasion Testing per STM-00149 -
Pass | Abrasion Testing per STM-00149
- Pass | Similar | |
| 16 CFR, Chapter II – Consumer
Product Safety Commission Part
1610 - Standard for the Flammability
of Clothing Textiles Class 1 - Pass | 16 CFR, Chapter II – Consumer
Product Safety Commission Part
1610 – Standard for the
Flammability of Clothing Textiles
Class 1 Pass | Identical | |
| Air Permeability (Back of Gown) per
STM-00162. NWSP 070.1.RO - Pass | Air Permeability (Back of Gown)
per STM-00162 - Pass | Similar | |
| Standard/Reference | Test Method | Data Generated | Meets
Requirements |
| Spray Impact (Critical
Zones) | AATCC 42 | Water Resistance | Pass |
| Hydrostatic Pressure
(Critical Zones) | AATCC 127 | Water Resistance | Pass |
| Liquid Barrier Performance | ANSI/AAMI
PB70:2012 Level 4 | Water Resistance | Pass |
| Spray Impact (Non-Critical
Zones) | AATCC 42 | Water Resistance | Pass |
| Liquid Barrier Performance | ANSI/AAMI
PB70:2012 Level 1 | Water Resistance | Pass |
| Grab Tensile, Peak Stretch,
and Peak Energy -
Nonwovens | ASTM D5034 – 9
2017 | Tensile Strength | Pass |
| Abrasion Resistance of
Nonwoven Fabrics | NWSP 020.5.RO
(15) 2015 | Abrasion Resistance | Pass |
| Synthetic Blood Penetration | ASTM F1670
(2017) | Resistance to
Penetration | Pass |
| Water Vapor Transmission
Rate | NWSP 070.4.RO
(15) 2015 | Water Vapor
Transmission | Pass |
| 180 Degree Peel Strength
of Non-Elastic Laminated
Nonwovens | STM-00197 Rev 1 | Peel Strength | Pass |
| Linting | ISO 9073-10
2003 | Particulate | Pass |
| Standard for the
Flammability for Clothing
Textiles | 16 CFR 1610 | Flammability | Pass |
| ISO L929 MEM Elution
Cytotoxicity | ISO 10993-5:2009 | Cytotoxicity | Pass |
| ISO Indirect Primary Skin
Irritation Test | ISO 10993-
10:2010 | Irritation | Pass |
| ISO Kligman Maximization
Test | ISO 10993-
10:2010 | Sensitization | Pass |
| EO Sterilization Residuals | ISO 109937-
7:2008 (R) 2012 | EO Residuals | Pass |
| Laser Ignition Resistance | ISO 11810-1:2015 | Laser Resistance | Pass |
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Image /page/7/Picture/0 description: The image contains two company logos. The first logo is for Owens & Minor, featuring a maroon-colored emblem with horizontal lines and the company name in gray text. The second logo is for Halyard, consisting of a blue circle with a white and green abstract shape inside, followed by the company name in bold blue letters. The logos are placed side by side.
8
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 font 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 circular emblem with a green triangle inside, accompanied by the word "HALYARD" in a bold, dark blue font.
9
Image /page/9/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 a stylized red "OM" and the company name in gray. The Halyard logo is on the right and features a green and blue stylized shape next to the company name in blue.
Performance Testing
Testing conducted to support the changes of the subject device shows that the AERO CHROME* Breathable Performance Surgical Gown is similar to the predicate device AERO CHROME* Breathable Performance Surgical Gown (K153255) in design, intended use, sterility, and technological characteristics. In the critical zone, the AERO CHROME* Breathable Performance Surgical Gowns meet the Level 4 AAMI
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Image /page/10/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 stylized font, with the words "Owens & Minor" to the right. The Halyard logo is on the right and consists of a green and blue symbol, with the word "HALYARD" in blue to the right.
PB70:2012 Liquid Barrier classification. The back of the gown meets the Level 1 AAMI PB70:2012 Liquid Barrier classification.
Summary of Non-Clinical Testing
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Image /page/11/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 "OM" in maroon and the company name in gray. The Halyard logo is on the right, with a blue circle containing a white and green shape, followed by the company name in blue. The logos are separated by a vertical gray line.
Conclusion
The conclusions drawn from the non-clinical tests demonstrate that the subject device is as safe, as effective and performs as well as or better than the legally marketed predicate device.