(135 days)
Not Found
No
The device is a surgical gown, and the description focuses on material properties and barrier performance, with no mention of software, algorithms, or data processing.
No
The device is described as a surgical gown intended to protect healthcare workers and patients from the transfer of microorganisms, body fluids, and particulate matter, not to treat a disease or condition.
No
The device description clearly states that these are surgical gowns intended for protection, not for diagnosis.
No
The device described is a physical surgical gown, not a software application. The description focuses on material composition, barrier performance, and physical testing.
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 gowns are for protecting healthcare workers 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 material composition and barrier properties of the gowns. There is no mention of analyzing samples from the human body or providing diagnostic information.
- Performance Studies: The performance studies listed are related to the physical and barrier properties of the gowns (liquid barrier, biocompatibility, strength, flammability, etc.). There are no studies related to diagnostic accuracy or performance.
- Lack of IVD Characteristics: The text does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring specific substances or markers
- Providing information for the diagnosis, monitoring, or treatment of a disease or condition
Therefore, the AERO CHROME* Select and A-Line Breathable Performance Surgical Gowns are classified as medical devices, specifically surgical apparel, and not as In Vitro Diagnostic devices.
N/A
Intended Use / Indications for Use
The AERO CHROME* Select Breathable Performance Surgical Gowns are sterile, single use surgical apparel intended to be worn by healthcate professionals to help protect both the healthcare worker from the transfer of microorganisms, body fluids, and particulate matter The AERO CHROME* Select Breathable Performance Surgical Gowns meet the Level 4 AAMI PB70:2012 Liquid Barrier classifications
The AERO CHROME* A-Line Breathable Performance Surgical Gowns are surgical apparel intended to be worn by healthcare professionals to help protect both the patient and the healthcare worker from the transfer of micro-organisms, body fluids, and particulate matter The AERO CHROME* A-Line Breathable Performance Surgical Gowns meet the Level 4 AAMI PB70 2012 Liquid Ba111er classifications.
Product codes (comma separated list FDA assigned to the subject device)
44696NS, 44697NS, 44698NS, 44699, 44706, 44707, 47580
Device Description
The AERO CHROME* Select 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 is comprised of the identical fabric as the front of the gown and meets AAMI Level 1 Liquid Barrier Performance Barrier. The AERO CHROME* Select 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: Large, X-Large, XX-Large.
The AERO CHROME* A-Line 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 is lightweight, air-breathable, and provides AAMI Level 1 protection. The AERO CHROME* A-Line Breathable Performance Surgical Gown is a single use gown, supplied sterile (via Ethylene Oxide) or as bulk non-sterile product. The gowns come in an X-Long, X- Large size.
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 was performed based on various standards:
- Liquid Barrier Performance (ANSI/AAMI PB70:2012 Level 4) for Resistance to Penetration by Blood-Borne Pathogens Using Phi-X174 Bacteriophage - Passed
- Liquid Barrier Performance (ANSI/AAMI PB70:2012 Level 1) for Water Resistance - Passed
- Grab Tensile, Peak Stretch, and Peak Energy - Nonwovens (ASTM D5034 - 9 2017) to Determine Tensile Strength - Passed
- Abrasion Resistance of Nonwoven Fabrics (NWSP 020.5.RO (15) 2015) to Evaluate Abrasion Resistance - Passed
- Synthetic Blood Penetration (ASTM F1670 (2017)) for Resistance to Penetration - Passed
- Water Vapor Transmission Rate (NWSP 070.4.RO (15) 2015) - Passed
- 180 Degree Peel Strength of Non-Elastic Laminated Nonwovens (STM-00197 Rev 1) - Passed (LSL:>125 grams)
- Linting (ISO 9073-10 2003) for Particulate - Passed
- Standard for the Flammability for Clothing Textiles (16 CFR 1610) - Met Class 1 requirements
- ISO L929 MEM Elution Cytotoxicity (ISO 10993-5:2009) - Passed (
§ 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 and Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" in a square and the words "U.S. Food & Drug Administration".
July 21, 2021
O&M Halyard, Inc Steve Dowdley Global Products, Director of Regulatory Affairs 1 Edison Drive Alpharetta, Georgia 30005
Re: K210688
Trade/Device Name: AERO CHROME* Select Breathable Performance Surgical Gown, AERO CHROME* A-Line Breathable Performance Surgical Gown Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical Apparel Regulatory Class: Class II Product Code: FYA Dated: July 16, 2021 Received: July 19, 2021
Dear Steve Dowdley:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration. listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's
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,
Clarence W. Murray, III, PhD Acting Assistant Director DHT4B: Division of Infection Control and Plastic Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known)
Device Name
AERO CHROME* Select Breathable Performance Surgical Gowns, AERO CHROME* A-Line Breathable Performance Sugraal Gowns
Indications for Use (Describe)
The AERO CHROME* Select Breathable Performance Surgical Gowns are sterile, single use surgical apparel intended to be worn by healthcate professionals to help protect both the healthcare worker from the transfer of microorganisms, body fluids, and particulate matter The AERO CHROME* Select Breathable Performance Surgical Gowns meet the Level 4 AAMI PB70:2012 Liquid Barrier classifications
| Non-Sterile Product Codes | ||
|---|---|---|
| Product Code | Device Description Gown | Gown Size |
| 44696NS | AERO CHROME* Select Breathable Performance Surgical Gown, L | Large |
| 44697NS | AERO CHROME* Select Breathable Performance Surgical Gown, XL | X-Large |
| 44698NS | AERO CHROME* Select Breathable Performance Surgical Gown, XXL | XX-Large |
| Sterile Product Codes | ||
| Product | Device Description Gown | Gown Size |
| 44699 | AERO CHROME*Select Breathable Performance Surgical Gown, L | Large |
| 44706 | AERO CHROME* Select Breathable Performance Surgical Gown, XL | X-Large |
| 44707 | AERO CHROME* Select Breathable Performance Surgical Gown, XXL | XX-Large |
The AERO CHROME* A-Line Breathable Performance Surgical Gowns are surgical apparel intended to be worn by healthcare professionals to help protect both the patient and the healthcare worker from the transfer of micro-organisms, body fluids, and particulate matter The AERO CHROME* A-Line Breathable Performance Surgical Gowns meet the Level 4 AAMI PB70 2012 Liquid Ba111er classifications.
| Sterile Product Codes | |
|---|---|
| Product | 47580 |
| Device Description Gown | AERO CHROME* A-Line Breathable Performance Surgical Gown with Towel, XL, X-Long |
| Gown Size | X-Large, X-Long |
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
3
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4
Image /page/4/Picture/0 description: The image contains two company logos. The first logo is for Owens & Minor, featuring the company's initials in a bold, maroon color with horizontal lines, followed by the company name in gray. The second logo is for Halyard, consisting of a green and white triangular shape resembling a roof, accompanied by the company name in bold, dark blue letters.
510(k) Summary
| 510(k)
| Number: | K210688 |
|---|---|
| Date | |
| Prepared: | March 05, 2021 |
| 510(k) | |
| Sponsor: | O&M Halyard Inc. |
| 9120 Lockwood Boulevard | |
| Mechanicsville, VA 23116 | |
| Regulatory | |
| Contact: | Steven Dowdley |
| 1 Edison Drive | |
| Alpharetta, GA 30005 | |
| 678-451-8062 | |
| Steven.dowdley@hyh.com | |
| Device Trade | |
| Names: | AERO CHROME* Select Breathable Performance Surgical Gowns AERO |
| CHROME* A-Line 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 | K200522 – AERO CHROME* Breathable Performance Surgical Gowns |
| Device | |
| Descriptions: | The AERO CHROME* Select 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 is comprised of the identical fabric as the | |
| front of the gown and meets AAMI Level 1 Liquid Barrier Performance | |
| Barrier. | |
| The AERO CHROME* Select 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: Large, X- | |
| Large, XX-Large. | |
| The AERO CHROME* A-Line 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 is lightweight, air-breathable, and provides | |
| AAMI Level 1 protection. | |
| The AERO CHROME* A-Line Breathable Performance Surgical Gown is a | |
| single use gown, supplied sterile (via Ethylene Oxide) or as bulk non- | |
| sterile product. The gowns come in an X-Long, X- Large size. | |
| Indications for | |
| Use for AERO | |
| CHROME* | |
| Select | |
| Breathable | |
| Performance | |
| Surgical | |
| Gowns: | The AERO CHROME* Select Breathable Performance Surgical Gowns are |
| sterile, single use surgical apparel intended to be worn by healthcare | |
| professionals to help protect both the patient and the healthcare worker | |
| from the transfer of micro-organisms, body fluids, and particulate matter. | |
| The AERO CHROME* Select Breathable Performance Surgical Gowns meet | |
| the Level 4 AAMI PB70:2012 Liquid Barrier classifications. | |
| Indications for | |
| Use for AERO | |
| CHROME* A- | |
| Line | |
| Breathable | |
| Performance | |
| Surgical | |
| Gowns: | The AERO CHROME* A-Line Breathable Performance Surgical Gowns are |
| sterile, single use surgical apparel intended to be worn by healthcare | |
| professionals to help protect both the patient and the healthcare worker | |
| from the transfer of micro-organisms, body fluids, and particulate matter. | |
| The AERO CHROME* A-Line Breathable Performance Surgical Gowns | |
| meet the Level 4 AAMI PB70:2012 Liquid Barrier classifications. |
5
Image /page/5/Picture/0 description: The image features the logos of two companies, Owens & Minor and Halyard. The Owens & Minor logo is on the left, with the company name in gray text next to a maroon emblem. The Halyard logo is on the right, with the company name in blue text next to a blue circle containing a white and green shape.
6
Image /page/6/Picture/0 description: The image shows the logos of two companies, Owens & Minor and Halyard. The Owens & Minor logo is on the left and consists of the letters "OM" in a stacked, horizontal line pattern, with the words "Owens & Minor" to the right of the letters. The Halyard logo is on the right and consists of a blue circle with a white and green abstract shape inside, with the word "HALYARD" in blue to the right of the circle.
Product Codes Subject to this Premarket Notification
| Product
| Code | Device Description |
|---|---|
| 44696NS | AERO CHROME* Select Breathable Performance Surgical Gown, L |
| 44697NS | AERO CHROME* Select Breathable Performance Surgical Gown, XL |
| 44698NS | AERO CHROME* Select Breathable Performance Surgical Gown, XXL |
| 44699 | AERO CHROME* Select Breathable Performance Surgical Gown, L |
| 44706 | AERO CHROME* Select Breathable Performance Surgical Gown, XL |
| 44707 | AERO CHROME* Select Breathable Performance Surgical Gown, XXL |
| 47580 | AERO CHROME* A-Line Breathable Performance Surgical Gown with Towel, XL, X-Long |
Technological Characteristic Comparison Table
| Attribute | Predicate Device
(AERO CHROME*
Breathable
Performance Surgical
Gown, K200522) | Subject Device –
AERO CHROME*
Select Breathable
Performance Surgical
Gowns, K210688 | Subject Device – AERO
CHROME* A-
Line Breathable
Performance Surgical
Gowns, K210688 | Comparison
Analysis |
|-------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------|
| FDA
Classification
Code | FYA | FYA | FYA | Identical |
| FDA Device
Classification | Class II | Class II | Class II | Identical |
| Common Device
Name | Surgical Gown | Surgical Gown | Surgical Gown | Identical |
| Trade Name | AERO CHROME*
Breathable
Performance Surgical
Gown | AERO CHROME*
Select Breathable
Performance Surgical
Gown | AERO CHROME* A-
Line Breathable
Performance Surgical
Gown | Similar |
| Indications for
Use | AERO CHROME*
Breathable
Performance Surgical
Gowns are sterile,
single use surgical
apparel intended to be
worn by healthcare
professionals | AERO CHROME*
Select Breathable
Performance Surgical
Gowns are sterile, single
use surgical apparel
intended to be worn by
healthcare professionals | AERO CHROME* A-
Line Breathable
Performance Surgical
Gowns are sterile, single
use surgical apparel
intended to be worn by
healthcare professionals | Identical |
7
Image /page/7/Picture/0 description: The image shows the logos of two companies, Owens & Minor and Halyard. The Owens & Minor logo is on the left and consists of the letters "OM" in a bold, red font, with the words "Owens & Minor" in a smaller, gray font to the right. The Halyard logo is on the right and consists of a blue circle with a white and green arrow inside, followed by the word "HALYARD" in a bold, blue font.
| Attribute | Predicate Device
(AERO CHROME*
Breathable Performance
Surgical Gown, K200522) | Subject Device -
AERO CHROME*
Select Breathable
Performance Surgical
Gowns, K210688 | Subject Device – AERO
CHROME* A-
Line Breathable
Performance Surgical
Gowns, K210688 | Comparison
Analysis |
|----------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------|
| | 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 | to help protect both the
patient and the
healthcare worker from
the transfer of
microorganisms, body
fluids, and particulate
matter. The AERO
CHROME* Select
Breathable Performance
Surgical Gowns meet the
Level 4 AAMI PB70 Liquid
Barrier classifications. | to help protect both the
patient and the
healthcare worker from
the transfer of
microorganisms, body
fluids, and particulate
matter. The AERO
CHROME* A-Line
Breathable Performance
Surgical Gowns meet the
Level 4 AAMI PB70 Liquid
Barrier classifications. | |
| How the
Device is
Supplied | Sterile or Bulk Non-
Sterile | Sterile or Bulk Non-
Sterile | Sterile | Similar |
| Sterilizat
ion
Method | Ethylene Oxide | Ethylene Oxide | Ethylene Oxide | Identical |
| SAL | 10-6 | 10-6 | 10-6 | Identical |
| Gown Color | Grey | Grey | Grey | Identical |
| Shelf-Life | 5 years | 5 years | 5 years | Identical |
| Gown Sizes | Small, Large, X-Large, XX-
Large, XXX-Large, X-Long
XL, X-Long XXL | Large, X-Large, XX-
Large | X-Long XL | Similar |
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 color with horizontal lines running through them, followed by the words "Owens & Minor" in a smaller, gray font. The second logo is for Halyard, consisting of a green and white abstract shape resembling a stylized "H" inside a blue circle, followed by the word "HALYARD" in a bold, blue font.
K210688
| Con-
struction
Overview | The AERO CHROME*
Breathable Performance
Surgical Gown is
manufactured from a
moisture-vapor
breathable, non-woven
fabric using a polymer
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, | The AERO CHROME*
Select Breathable
Performance Surgical
Gown is manufactured
from a moisture-vapor
breathable, non-woven
fabric using a polymer
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, | The AERO CHROME*
A-Line Breathable
Performance Surgical
Gown is manufactured
from a moisture-vapor
breathable, non-woven
fabric using a polymer
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, | Select Gown
- Similar
A-Line
Gown -
Identical |
| ------------------------------- | ----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ | --------------------------------------------------------------- |
|---|
9
Image /page/9/Picture/0 description: The image features the logos of two companies, Owens & Minor and Halyard. The Owens & Minor logo is on the left, with a stylized red emblem and the company name in gray text. To the right is the Halyard logo, which includes a blue circle with a green upward-pointing arrow inside, followed by the company name in bold, dark blue letters.
K210688
| Attribute | Predicate Device
(AERO CHROME*
Breathable
Performance Surgical
Gown, K200522) | Subject Device –
AERO CHROME*
Select Breathable
Performance Surgical
Gowns, K210688 | Subject Device – AERO
CHROME* A-
Line Breathable
Performance Surgical
Gowns, K210688 | Comparison Analysis |
|------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------|
| | 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. | 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
identical material that
comprises the front of
the gown also comprises
the back of the gown in
one continuous material.
Therefore, this gown
does not have side
seams. | 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*
A-Line 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 | Yes | Identical |
Performance Testing
| Predicate Device -AERO CHROME* Breathable
Performance Surgical Gowns, K200522 | Subject Devices - AERO CHROME* Select
Breathable Performance Surgical Gowns
and AERO CHROME* A-Line Breathable
Performance Surgical Gowns, K210688 | 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 | Biocompatibility per ISO 10993 – Pass the
device under the conditions of the | Identical |
10
Image /page/10/Picture/0 description: The image contains two company logos. On the left is the Owens & Minor logo, which features the letters "OM" in a bold, maroon font, with the words "Owens & Minor" in a smaller, gray font to the right. On the right is the Halyard logo, which features a green and white icon inside a blue circle, followed by the word "HALYARD" in a bold, blue font.
| Predicate Device -AERO CHROME* Breathable
Performance Surgical Gowns, K200522 | Subject Devices - AERO CHROME* Select
Breathable Performance Surgical Gowns
and AERO CHROME* A-Line Breathable
Performance Surgical Gowns, K210688 | Comparison Analysis |
|---------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------|
| non-cytotoxic, non-irritant, and non-sensitizing | study is non-cytotoxic, non-irritant, and non-sensitizing | |
| Water Vapor Transmission Rate of Materials
(MOCON) - Pass | Water Vapor Transmission Rate of
Materials (MOCON) - Pass | Identical |
| Linting per ISO 9073-10 - Pass | Linting per ISO 9073-10 - Pass | Identical |
| 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 | Identical |
| Peel Strength per STM-00197 - Pass | Peel Strength per STM-00197 - Pass | Identical |
| Hydrohead Testing - Pass | Hydrohead Testing - Pass | Identical |
| Abrasion Testing per STM-00149 - Pass | Abrasion Testing per STM-00149 -
Pass | Identical |
| 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 |
Summary of Non-Clinical Testing
| Standard/Reference | Test Method | Data Generated | Meets
Requirements |
|----------------------------|--------------------------------|------------------------------------------------------------------------------------------------|-----------------------|
| Liquid Barrier Performance | ANSI/AAMI
PB70:2012 Level 4 | Resistance to
Penetration by
Blood-Borne
Pathogens Using
Phi-X174
Bacteriophage | Pass |
11
Image /page/11/Picture/0 description: The image contains two company logos side by side. The first logo is for Owens & Minor, featuring the letters "OM" in a bold, maroon color with horizontal lines, accompanied by the company name in gray. The second logo is for Halyard, consisting of a blue circle with a stylized white and green shape inside, followed by the company name in bold, blue letters.
| Standard/Reference/ Test Method | Purpose | Acceptance Criteria | Results |
|---|---|---|---|
| Liquid Barrier Performance | |||
| ANSI/AAMI PB70:2012 Level 1 | Determine Water | ||
| Resistance | Meets standard | ||
| requirements for | |||
| Level | |||
| 1 Liquid Barrier | Pass | ||
| Grab Tensile, Peak Stretch, and Peak | |||
| Energy - Nonwovens | |||
| ASTM D5034 - 9 2017 | Determine Tensile | ||
| Strength | Meets standard | ||
| requirements for | |||
| ASTM D5034 -9 2017 | Pass | ||
| Abrasion Resistance of | |||
| Nonwoven Fabrics | |||
| NWSP 020.5.RO (15) 2015 | Evaluate Abrasion | ||
| Resistance | Meets requirements | ||
| of standard NWSP | |||
| 020.5.RO (15) 2015 | Pass | ||
| Synthetic Blood Penetration | |||
| ASTM F1670 (2017) | Resistance to | ||
| Penetration | Meets standard | ||
| requirements for | |||
| ASTM F1670 | |||
| (2017) | Pass | ||
| Water Vapor Transmission Rate | |||
| NWSP 070.4.RO (15) 2015 | Water Vapor | ||
| Transmission | Meets standard | ||
| requirements for | |||
| NWSP 070.4.RO (15) | |||
| 2015 | Pass | ||
| 180 Degree Peel Strength of Non- | |||
| Elastic Laminated Nonwovens | |||
| STM-00197 Rev 1 | Peel Strength | LSL:>125 grams | Pass |
| Linting ISO 9073-10 2003 | Particulate | Meets requirement | |
| for ISO 9073-10 2003 | Pass | ||
| Standard for the Flammability for | |||
| Clothing Textiles16 CFR 1610 | Flammability | Meets Class 1 | |
| requirements | Pass | ||
| ISO L929 MEM Elution | |||
| Cytotoxicity ISO 10993-5:2009 | Cytotoxicity |