(155 days)
Not Found
No
The device description and performance studies focus on material properties and barrier protection, with no mention of AI or ML.
No.
The device is a surgical gown intended to protect against the transfer of microorganisms, body fluids, and particulate matter, not to treat a disease or condition.
No
Explanation: The device is a surgical gown intended to protect healthcare workers and patients from microorganisms and fluids. It does not perform any diagnostic function.
No
The device description clearly indicates it is a physical surgical gown made of fabric materials, not software.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is "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." This describes a barrier device for personal protection, not a device used to examine specimens from the human body to provide information for diagnosis, monitoring, or treatment.
- Device Description: The description focuses on the physical construction and barrier properties of a surgical gown.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, reagents, or any diagnostic procedures.
Therefore, the Aero Chrome* Breathable Performance Surgical Gowns are classified as medical devices, specifically surgical apparel, and not IVDs.
N/A
Intended Use / 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 requirements of the AAMI PB70:2012 Liquid Barrier classifications.
The Aero Chrome* Breathable Performance Surgical Gowns are also sold as bulk nonsterile, single use items, to repackager/relabeler establishments for further packaging and Ethylene Oxide (EtO) sterilization
Product codes (comma separated list FDA assigned to the subject device)
FYA
Device Description
The Aero Chrome* Breathable Performance Surgical Gowns have a Spunbond/Film/Spunbond/Meltblown/Spunbond design (SFSMS) that provides AAMI Level 4 liquid barrier protection in the critical zones of the gown. The back of the Aero Chrome* Breathable Performance Surgical Gown in the non-critical zone has a SMS Spunbond/meltblown/spunbond) fabric that is air-breathable and provides AAMI Level 1 liquid barrier protection. The Aero Chrome* Breathable Performance Surgical Gowns are single use, disposable medical device that will be provided in a variety of sterile and non-sterile packaging configurations described below.
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)
Non-Clinical Testing:
- Standard for the Flammability for Clothing Textiles (16 CFR 1610): Flammability, Pass
- ISO 10993-5:2009 Biological Evaluation of Medical Devices-Part 5: Cytotoxicity, Pass, under the conditions of the study non-cytotoxic
- ISO 10993-10:2010 Biological Evaluation of Medical Devices-Part 10 Skin Irritation Study: Irritation, Pass, under the conditions of the study a negligible irritant
- ISO 10993-10:2010 Biological Evaluation of Medical Devices-Part 10 Sensitization Test: Sensitization, Pass, under the conditions of the study non-sensitizing
- ISO 10993-7:2008, Ethylene Oxide sterilization residuals: EO residuals, Pass
- Laser Ignition Resistance (ISO 11810-1 (2005)): Laser resistance, Pass
- AAMI Liquid Barrier Performance in Critical Zone (body, sleeves, and ties) (AAMI PB70:2012 Level 4): Resistance to Blood-Borne Pathogens Using Phi-X174 Bacteriophage, Pass
- AAMI Liquid Barrier Performance Level 1 in non-critical side seams, raglan sleeve to shoulder seams, and SMS area in back of gown (AAMI PB70:2012 Level 1): Water resistance, Pass
- Spray Impact (1.2 osy SMS in non-critical zone on back) (AATCC 42:2013): Water resistance, Pass
- Grab Tensile, Peak Stretch, and Peak Energy - Nonwovens (ASTM D5034 (2009)): Tensile Strength, Pass
- Abrasion Resistance and Surface Bonding of SMS Laminates (WSP 20.5 (2008)): Abrasion resistance, Pass
- Synthetic Blood Penetration (fabric only in critical zone) (ASTM-1670-08 (2008)): Resistance to penetration, Pass
- Mass Per Area (Basis Weight) of Materials (D3776 (2009)): Fabric basis weight, Pass
- Water Vapor Transmission Rate Through Nonwovens and Plastic Films (WSP 70.4 (2008)): Water Vapor Transmission, Pass
- Degree Peel Strength of Laminated Nonwovens - Raw Materials (STM-00197(2010)): Peel Strength, Pass
- Resistance to Linting Dry Particle Generation (INDA WSP 160.1 (2009)): Particulate, Pass
Performance Testing (comparison to predicate K140539):
- Performance Testing in Critical Zone: ANSI/AAMI PB70: 2012 Level 4 Liquid Barrier Requirements - Pass (Predicate: Level 3)
- W SP 70.4 (STM-00164)-Water Vapor Transmission Rate - Pass (Predicate: Same)
- W SP 160.1 (STM-00353) Test Method for Resistance to Linting: Dry Particle Generation with a Modified Gelbo Flex Unit -Pass (Predicate: Same)
- ASTM D 5034 - 2009 Standard Test Method For Breaking Strength and Elongation of Textile Fabrics (Grab Test) - Pass (Predicate: Same)
- ASTM F1670:2008 for fabric in critical zone- Pass (Predicate: Same)
- STM- 00149 (W SP 20.5 2008), Abrasion Resistance Test - Pass (Predicate: Same)
- Biocompatibility per ISO 10993 – Pass, the device under the conditions of the study is non-cytotoxic, non-irritant, and non-sensitizing. (Predicate: Same, device under the conditions of the study was non-cytotoxic, non-irritant, and non-sensitizing.)
- 16 CFR, Chapter II--Consumer Product Safety Commission Part 1610 -Standard For The Flammability of Clothing Textiles Class I - Pass (Predicate: Same)
- Laser Ignition Resistance/ ISO 11810- Pass (Predicate: Same)
Conclusion: The performance testing submitted for the Aero Chrome* Breathable Performance Surgical Gown demonstrates substantial equivalence to the predicate Aero Blue* Performance Surgical Gown (K140539) in intended use, design, materials, performance, and biocompatibility attributes.
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/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
April 13, 2016
Halyard Health, Inc. David Lee Associate Director, Regulatory Affairs 5405 Windward Parkway Alpharetta, Georgia 30004
Re: K153255
Trade/Device Name: Aero Chrome* Breathable Performance Surgical Gown Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical Apparel Regulatory Class: II Product Code: FYA Dated: March 7, 2016 Received: March 8, 2016
Dear David Lee:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug. and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR
1
Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours.
Tejashri Purohit-Sheth, M.D.
Tejashri Purohit-Sheth, M.D. Clinical Deputy Director DAGRID/ODE/CDRH FOR
Erin I. Keith, M.S. Division Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.
510(k) Number (if known) K153255
Device Name Aero Chrome* Breathable Performance Surgical Gown
Indications for Use (Describe)
The Aero Chrome* Breathable Performance Surgical Gowns are sterile, single use surgical apparel intended to be worn by healthcare professionals to help protect both the patient and the healthcare worker from the transfer of microorganisms, body fluids, and particulate matter. The Aero Chrome* Breathable Performance Surgical Gowns meet the Level 4 requirements of the AAMI PB70:2012 Liquid Barrier classifications.
The Aero Chrome* Breathable Performance Surgical Gowns are also sold as bulk nonsterile, single use items, to repackager/relabeler establishments for further packaging and Ethylene Oxide (EtO) sterilization
| Type of Use (Select one or both, as applicable) | |
|---|---|
| Prescription Use (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 801 Subpart C) |
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DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
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"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
This submission addresses the Aero Chrome* Breathable Performance Surgical Gown models described below.
STERILE CODES
| PRODUCT
| STOCK CODE | DESCRIPTION | GOWN SIZE |
|---|---|---|
| 44672 | Aero Chrome* Breathable Performance | |
| Surgical Gown, S | Small | |
| 44673 | Aero Chrome* Breathable Performance | |
| Surgical Gown, L | Large | |
| 44674 | Aero Chrome* Breathable Performance | |
| Surgical Gown, XL | Xlarge | |
| 44675 | Aero Chrome* Breathable Performance | |
| Surgical Gown, XXL | XXLarge | |
| 44676 | Aero Chrome* Breathable Performance | |
| Surgical Gown, XXXL | XXXLarge | |
| 44677 | Aero Chrome* Breathable Performance | |
| Surgical Gown, L, X-Long | Large Xlong | |
| 44678 | Aero Chrome* Breathable Performance | |
| Surgical Gown, XL, X-Long | XLarge Xlong | |
| 44679 | Aero Chrome* Breathable Performance | |
| Surgical Gown, XXL, X-Long | XXLarge Xlong |
NON-STERILE CODES
| PRODUCT | DESCRIPTION | GOWN SIZE |
|---|---|---|
| STOCK CODE | ||
| 44661NS | Aero Chrome* Breathable Performance | |
| Surgical Gown, S | Small | |
| 44662NS | Aero Chrome* Breathable Performance | |
| Surgical Gown, L | Large | |
| 44663NS | Aero Chrome* Breathable Performance | |
| Surgical Gown, L - Handi-Bin | Large | |
| 44664NS | Aero Chrome* Breathable Performance | |
| Surgical Gown, XL | Xlarge | |
| 44665NS | Aero Chrome* Breathable Performance | |
| Surgical Gown, XL - Handi-Bin | Xlarge | |
| 44666NS | Aero Chrome* Breathable Performance | |
| Surgical Gown, XXL | XXLarge | |
| 44667NS | Aero Chrome* Breathable Performance | |
| Surgical Gown, L, X-Long | Large Xlong | |
| 44668NS | Aero Chrome* Breathable Performance | |
| Surgical Gown, XL, X-Long | XLarge Xlong | |
| 44669NS | Aero Chrome* Breathable Performance | |
| Surgical Gown, XXL, X-Long | XXLarge Xlong |
4
510(k) Summary
| Date Summary
| was Prepared: | April 13, 2016 |
|---|---|
| 510(k) | |
| Submitter: | David M. Lee, JD |
| Associate Director of Regulatory Affairs, | |
| HALYARD HEALTH | |
| 5405 Windward Parkway | |
| Alpharetta, GA 30004 | |
| 470 448 5182 | |
| David.lee@hyh.com | |
| Primary Contact | |
| for this 510(k) | |
| Submission: | David M. Lee, JD |
| Associate Director of Regulatory Affairs, | |
| HALYARD HEALTH | |
| 5405 Windward Parkway | |
| Alpharetta, GA 30004 | |
| 470 448 5182 | |
| David.lee@hyh.com | |
| Device Trade | |
| Name: | Aero Chrome* Breathable Performance Surgical Gown |
| (hereinafter described as "Aero Chrome*") | |
| Device Common | |
| Names | Surgical Gown |
| Device Product | |
| Codes, | |
| Classification | |
| Name and | |
| Regulation: | FYA |
| Class II | |
| 878.4040 Surgical Apparel |
5
Predicate Device
The Aero Chrome* Breathable Performance Surgical Gown under submission is substantially equivalent to the predicate device, the Aero Blue* Performance Surgical Gown (K140539).
Device The Aero Chrome* Breathable Performance Surgical Gowns Description: have a Spunbond/Film/Spunbond/Meltblown/Spunbond design (SFSMS) that provides AAMI Level 4 liquid barrier protection in the critical zones of the gown. The back of the Aero Chrome* Breathable Performance Surgical Gown in the non-critical zone has a SMS Spunbond/meltblown/spunbond) fabric that is air-breathable and provides AAMI Level 1 liquid barrier protection. The Aero Chrome* Breathable Performance Surgical Gowns are single use, disposable medical device that will be provided in a variety of sterile and non-sterile packaging configurations described below.
The Aero Chrome* Breathable Performance Surgical Gowns are Intended Use: sterile, single use surgical apparel intended to be worn by healthcare professionals to help protect both the patient and the healthcare worker from the transfer of microorganisms, body fluids, and particulate matter. The Aero Chrome* Breathable Performance Surgical Gowns meet the Level 4 requirements of the AAMI PB70:2012 Liquid Barrier classifications.
The Aero Chrome* Breathable Performance Surgical Gowns are also sold as bulk non-sterile, single use items, to repackager/relabeler establishments for further packaging and Ethylene Oxide (EtO) sterilization
This submission covers the Aero Chrome* Breathable Performance Surgical Gowns models described below.
6
Product Code and Description
STERILE CODES
| PRODUCT STOCK
| CODE | DESCRIPTION | GOWN SIZE |
|---|---|---|
| 44672 | Aero Chrome* Breathable Performance | |
| Surgical Gown, S | Small | |
| 44673 | Aero Chrome* Breathable Performance | |
| Surgical Gown, L | Large | |
| 44674 | Aero Chrome* Breathable Performance | |
| Surgical Gown, XL | Xlarge | |
| 44675 | Aero Chrome* Breathable Performance | |
| Surgical Gown, XXL | XXLarge | |
| 44676 | Aero Chrome* Breathable Performance | |
| Surgical Gown, XXXL | XXXLarge | |
| 44677 | Aero Chrome* Breathable Performance | |
| Surgical Gown, L, X-Long | Large Xlong | |
| 44678 | Aero Chrome* Breathable Performance | |
| Surgical Gown, XL, X-Long | XLarge Xlong | |
| 44679 | Aero Chrome* Breathable Performance | |
| Surgical Gown, XXL, X-Long | XXLarge Xlong |
NON-STERILE CODES
| PRODUCT STOCK
| CODE | DESCRIPTION | GOWN SIZE |
|---|---|---|
| 44661NS | Aero Chrome* Breathable Performance Surgical Gown, S | Small |
| 44662NS | Aero Chrome* Breathable Performance Surgical Gown, L | Large |
| 44663NS | Aero Chrome* Breathable Performance Surgical Gown, L - Handi-Bin | Large |
| 44664NS | Aero Chrome* Breathable Performance Surgical Gown, XL | Xlarge |
| 44665NS | Aero Chrome* Breathable Performance Surgical Gown, XL - Handi-Bin | Xlarge |
| 44666NS | Aero Chrome* Breathable Performance Surgical Gown, XXL | XXLarge |
| 44667NS | Aero Chrome* Breathable Performance Surgical Gown, L, X-Long | Large Xlong |
| 44668NS | Aero Chrome* Breathable Performance Surgical Gown, XL, X-Long | XLarge Xlong |
| 44669NS | Aero Chrome* Breathable Performance Surgical Gown, XXL, X-Long | XXLarge Xlong |
7
Summary of Non-Clinical Testing
| Standard or Reference | Test Method | Data Generated | Meets
Requirement |
|-----------------------------------------------------------------------------------------------------------------------------------------|---------------------------|------------------------------------------------------------------------------------------------|------------------------------------------------------------------------|
| Standard for the Flammability for Clothing Textiles | 16 CFR 1610 | Flammability | Pass |
| ISO 10993-5:2009 Biological Evaluation of Medical
Devices-Part 5: | Cytotoxicity | Cytotoxicity | Pass, under the
conditions of the
study non-
cytotoxic |
| ISO 10993-10:2010 Biological Evaluation of Medical
Devices-Part 10 | Skin Irritation Study | Irritation | Pass, under the
conditions of the
study a
negligible irritant |
| ISO 10993-10:2010 Biological Evaluation of Medical
Devices-Part 10 | Sensitization Test | Sensitization | Pass, under the
conditions of the
study non-
sensitizing |
| ISO 10993-7:2008, Ethylene Oxide sterilization
residuals | EO residuals | EO residuals | Pass |
| Laser Ignition Resistance | ISO 11810-1 (2005) | Laser resistance | Pass |
| AAMI Liquid Barrier Performance in Critical Zone
(body, sleeves, and ties) | AAMI PB70:2012
Level 4 | Resistance to
Penetration by
Blood-Borne
Pathogens Using
Phi-X174
Bacteriophage | Pass |
| AAMI Liquid Barrier Performance Level 1 in non-critical
side seams, raglan sleeve to shoulder seams, and
SMS area in back of gown | AAMI PB70:2012
Level 1 | Water resistance | Pass |
| Spray Impact
(1.2 osy SMS in non-critical zone on back) | AATCC 42:2013 | Water resistance | Pass |
| Grab Tensile, Peak Stretch, and Peak Energy -
Nonwovens | ASTM D5034
(2009) | Tensile Strength | Pass |
| Abrasion Resistance and Surface Bonding of SMS
Laminates | WSP 20.5 (2008) | Abrasion resistance | Pass |
| Synthetic Blood Penetration
(fabric only in critical zone) | ASTM-1670-08
(2008) | Resistance to
penetration | Pass |
| Mass Per Area (Basis Weight) of Materials | D3776 (2009) | Fabric basis weight | Pass |
| Water Vapor Transmission Rate Through Nonwovens
and Plastic Films | WSP
70.4 (2008) | Water Vapor
Transmission | Pass |
| Degree Peel Strength of Laminated Nonwovens - Raw
Materials | STM-00197(2010) | Peel Strength | Pass |
| Resistance to Linting Dry Particle Generation | INDA WSP 160.1
(2009) | Particulate | Pass |
Test results establish that the product met the predetermined specifications.
8
Substantial Equivalence Table
| Attribute | Device Under Submission:
Aero Chrome* Breathable
Performance Surgical Gown | Predicate Device of this 510(k):
K140539 Aero Blue*
Performance Surgical Gown |
|--------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 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
requirements of the AAMI PB70:2012
Liquid Barrier classifications.
The Aero Chrome* Breathable
Performance Surgical Gowns are also
sold as bulk non-sterile, single use
items, to repackager/relabeler
establishments for further packaging
and Ethylene Oxide (EtO) sterilization | 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
requirements of the AAMI PB70: 2012
Liquid Barrier classifications.
The Aero Blue* Performance Surgical
Gowns, are also sold as bulk non-
sterile, single use items, to
repackager/relabeler establishments for
further packaging and Ethylene Oxide
(EtO) sterilization. |
| How
supplied | Sterile ( $10^{-6}$ ) or bulk non-sterile | Same |
| Sterilization
Method | Ethylene Oxide | Same |
| SAL | $10^{-6}$ | Same |
| Gown color | Gray | Blue |
| Gown sizes | Small, Large, X-Large, XX-Large,
XXX-Large, L X-Long, XXL X- Long | Small, Large, X-Large, XX-Large,
XXX-Large |
| Construction
Overview | The Aero Chrome* Breathable
Performance Surgical Gowns under
submission are manufactured from a
moisture-vapor breathable, repellent,
non-woven fabric using a polymer
blend of polypropylene and
polyethylene. The front body and
sleeve fabric is a three layer film
laminate. This fabric is an SFSMS
design Spunbond/Film/Spunbond-
Meltblown-Spunbond that is adhesively
bonded together. The Aero Chrome*
Breathable Performance Surgical
Gowns in the critical zone meet AAMI-
4 liquid barrier requirements, while
back of gown in the non-critical zone is
composed of a breathable SMS fabric
with an AAMI level 1 liquid barrier
protection. | The Aero Blue Performance Surgical
Gown is manufactured from a
moisture-vapor breathable, repellent,
non-woven fabric using a polymer
blend of polypropylene and
polyethylene. The front body and
sleeve fabric is a three layer film
laminate. This fabric is an SFSMS
design Spunbond/
Film/Spunbond-Meltblown-Spunbond
that is adhesively bonded together.
Front of Gown meets meet AAMI-3
liquid barrier requirements, while back
of Gown in the non-critical zone is
composed of a breathable SMS fabric
with an AAMI level 1 liquid barrier
protection. |
9
| Not
made
with
natural
rubber
| latex | Yes | Same |
|---|---|---|
| --------------------------------------------------- | ----- | ------ |
Performance Testing
| Attribute | Device Under Submission:
Aero Chrome* Breathable Performance
Surgical Gowns | Predicate Device of this
510(k):
K140539 Aero Blue*
Performance Surgical Gown, |
|--------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------|
| Performance
Testing in
Critical Zone | ANSI/AAMI PB70: 2012 Level 4 Liquid Barrier
Requirements - Pass | ANSI/AAMI PB70: 2012 Level
3 |
| | W SP 70.4 (STM-00164)-W ater Vapor
Transmission Rate - Pass | Same |
| | W SP 160.1 (STM-00353) Test Method for
Resistance to Linting: Dry Particle Generation
with a Modified Gelbo Flex Unit -Pass | Same |
| | ASTM D 5034 - 2009 Standard Test Method For
Breaking Strength and Elongation of Textile
Fabrics (Grab Test) - Pass | Same |
| | ASTM F1670:2008 for fabric in critical zone-
Pass | Same |
| | STM- 00149 (W SP 20.5 2008), Abrasion
Resistance Test - Pass | Same |
| | Biocompatibility per ISO 10993 – Pass, the
device under the conditions of the study is non-
cytotoxic, non-irritant, and non-sensitizing. | Same, device under the
conditions of the study was non-
cytotoxic, non-irritant, and non-
sensitizing. |
| | 16 CFR, Chapter II--Consumer Product Safety
Commission Part 1610 -Standard For The
Flammability of Clothing Textiles Class I - Pass | Same |
| | Laser Ignition Resistance/ ISO 11810- Pass | Same |
Conclusion The performance testing submitted for the Aero Chrome* Breathable Performance Surgical Gown demonstrates substantial equivalence to the predicate Aero Blue* Performance Surgical Gown (K140539) in intended use, design, materials, performance, and biocompatibility attributes.
*Registered Trademark or Trademark of Halyard Health, Inc. or its affiliates.