(245 days)
No
The device is a physical isolation gown and the summary describes only material properties and performance testing related to barrier protection and physical integrity. There is no mention of software, data processing, or any AI/ML related terms.
No
The device is an isolation gown intended to provide barrier protection, not to treat or cure any medical condition.
No
Explanation: The device is an isolation gown intended to provide barrier protection, not to diagnose medical conditions.
No
The device is a physical isolation gown made of polypropylene SMS material, not software. The performance studies are related to the physical properties of the gown.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the gowns are "intended to be worn by healthcare personnel in isolations to provide moderate barrier protection for healthcare personnel and patients from microorganism transfer, body fluids, and particulate matter." This describes a physical barrier device used for personal protection, not a device used to examine specimens derived from the human body to provide information for diagnosis, monitoring, or treatment.
- Device Description: The description details the physical characteristics and materials of the gown, consistent with personal protective equipment.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, reagents, calibrators, controls, or any other components typically associated with in vitro diagnostics.
- Performance Studies: The performance studies focus on physical properties like barrier performance (spray impact, hydrostatic pressure), strength (grab strength, tear strength, seam strength), static decay, biocompatibility (cytotoxicity, irritation, sensitization), basis weight, flammability, and lint generation. These are relevant to the performance of a protective garment, not an IVD.
In summary, the Halyard Tri-Layer AAMI 3 Isolation Gown is a piece of personal protective equipment (PPE) designed to provide a physical barrier, not a device used for in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
Halyard Tri-Layer AAMI 3 Isolation Gowns are intended to be worn by healthcare personnel in isolations to provide moderate barrier protection for healthcare personnel and patients from microorganism transfer, body fluids, and particulate matter. The gowns are non-sterile, single use, and meet AAMI PB70:2012 level 3 Liquid Barrier performance requirements. Not intended for use in the operating room.
Product codes (comma separated list FDA assigned to the subject device)
FYC
Device Description
The Halyard Tri-Layer AAMI 3 Isolation Gown ("Isolation Gown") is a single use gown, supplied non-sterile. The gowns come in the following sizes: Large, X-Large. These surgical gowns are apparel that are intended to be worn by healthcare professionals to protect from varying levels of fluid contact (low to moderate). These surgical gowns meet the AAMI PB70:2012 Liquid Barrier Performance Classification of Protective Apparel and Drapes Intended for Use in Health Care Facilities, Level 3 Requirements. These Isolation Gowns are manufactured from three-layer full length polypropylene SMS material, with neck tape, elastic cuffs, and waist belt closure systems.
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 personnel in isolation applications
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:
- Test: Spray Impact - Front/Back/Sleeve Panel; Method: AATCC 42; Acceptance Criteria: ≤ 1.0g n=35, c=3; Result: Pass
- Test: Spray Impact - Sleeve/Armhole Seam/Shoulder Seam; Method: AATCC 42; Acceptance Criteria: ≤ 1.0g n=35, c=3; Result: Pass
- Test: Spray Impact - Front Tie; Method: AATCC 42; Acceptance Criteria: ≤ 1.0g n=35, c=3; Result: Pass
- Test: Static Decay MD; Method: STM-00180; Acceptance Criteria: USL 0.5s n=36, c=0; Result: Pass
- Test: Static Decay CD; Method: STM-00180; Acceptance Criteria: USL 0.5s n=36, c=0; Result: Pass
- Test: ISO L929 MEM Elution Cytotoxicity; Method: ISO 10993-5:2009; Acceptance Criteria: ≤ Grade 2 (mild reactivity); Result: Pass
- Test: ISO Irritation Test; Method: ISO 10993-10:2010; Acceptance Criteria: ≤ 0.4 Primary Irritation (PII); Result: Pass
- Test: ISO Kligman Maximization Test; Method: ISO 10993-10:2010; Acceptance Criteria: Grade
§ 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.
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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, with the letters "FDA" in a blue square. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
May 16, 2024
Owens & Minor (O&M) Halyard, Inc. Gabriel Dockery Specialist. Global Regulatory Affairs 9120 Lockwood Blvd Mechanicsville, Virginia 23116
Re: K232849
Trade/Device Name: Halyard Tri-Layer AAMI 3 Isolation Gown, L, Blue (54310), Halyard Tri-Layer AAMI 3 Isolation Gown, X-Large, Blue (54311) Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical Apparel Regulatory Class: Class II Product Code: FYC Dated: April 17, 2024 Received: April 18, 2024
Dear Gabriel Dockery:
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 (the 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 available 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.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device"
1
(https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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.
Allan Guan-S
For Bifeng Qian, M.D., Ph.D. Assistant Director DHT4B: Division of Infection Control and Plastic and Reconstructive Surgery Devices
2
OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
3
Indications for Use
510(k) Number (if known) K232849
Device Name
Halyard Tri-Layer AAMI 3 Isolation Gown, L, Blue (54310), Halyard Tri-Layer AAMI 3 Isolation Gown, X-Large, Blue (54311)
Indications for Use (Describe)
Halyard Tri-Layer AAMI 3 Isolation Gowns are intended to be worn by healthcare personnel in isolations to provide moderate barrier protection for healthcare personnel and patients from microorganism transfer, body fluids, and particulate matter. The gowns are non-sterile, single use, and meet AAMI PB70:2012 level 3 Liquid Barrier performance requirements. Not intended for use in the operating room.
| 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) |
|X Over-The-Counter Use (21 CFR 801 Subpart C)
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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 stylized, layered font in maroon, followed by the company name in gray. To the right is the Halyard logo, which includes a green and white upward-pointing arrow inside a dark blue circle, followed by the company name in dark blue sans-serif font.
510(k) Summary
| 510(k)
| Number: | K232849 |
|---|---|
| Date | |
| Prepared: | May 16, 2024 |
| 510(k) | |
| Sponsor: | O&M Halyard Inc. |
| 9120 Lockwood Boulevard | |
| Mechanicsville, VA 23116 | |
| Regulatory | |
| Contact: | Gabriel Dockery |
| 1 Edison Drive | |
| Alpharetta, GA 30005 | |
| 470-280-4388 | |
| Gabriel.dockery@hyh.com | |
| Device Trade | |
| Names: | Halyard Tri-Layer AAMI 3 Isolation Gowns |
| Device Common | |
| Name: | Isolation Gown |
| FDA Device | |
| Product Code: | FYC |
| FDA Device | |
| Classification: | Class II |
| FDA Device | |
| Name: | Gown, Isolation, Surgical |
| FDA | |
| Regulation | |
| Number: | 21 CFR 878.4040 |
| Predicate | |
| Device: | K160361 – PRIMAGARD AAMI PB70:2012 Level 3 gowns |
Device Descriptions:
5
Image /page/5/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 green and blue circular design with the word "HALYARD" in a bold, blue font to the right.
The Halyard Tri-Layer AAMI 3 Isolation Gown ("Isolation Gown") is a single use gown, supplied non-sterile. The gowns come in the following sizes: Large, X-Large. These surgical gowns are apparel that are intended to be worn by healthcare professionals to protect from varying levels of fluid contact (low to moderate). These surgical gowns meet the AAMI PB70:2012 Liquid Barrier Performance Classification of Protective Apparel and Drapes Intended for Use in Health Care Facilities, Level 3 Requirements. These Isolation Gowns are manufactured from three-layer full length polypropylene SMS material, with neck tape, elastic cuffs, and waist belt closure systems.
| Indications for
Use for
Halyard Tri-
Layer AAMI 3
Isolation
Gowns : | Halyard Tri-Layer AAMI 3 Isolation Gowns are intended to be worn
by healthcare personnel in isolation applications to provide moderate
barrier protection for healthcare personnel and patients from
microorganism transfer, body fluids, and particulate matter. The
gowns are non-sterile, single use, and meet AAMI PB70:2012 level
3 Liquid Barrier performance requirements. Not intended for use in
the operating room. |
|------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use : | The Halyard Tri-Layer AAMI 3 Isolation Gowns are non-sterile, |
- single use surgical apparel intended to be worn by healthcare professionals for protection from varying levels of fluid contact (low to moderate).
Product Codes Subject to this Premarket Notification
| Product
| Code | Device Description |
|---|---|
| 54310 | Halyard Tri-Layer AAMI 3 Isolation Gown, L, Blue |
| 54311 | Halyard Tri-Layer AAMI 3 Isolation Gown, X-Large, Blue |
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Image /page/6/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 consists of a stylized green and white shape inside a dark blue circle, followed by the word "HALYARD" in a bold, dark blue font.
Technological Characteristic Comparison Table
| Attribute | Subject Device (Halyard
Tri-Layer AAMI 3
Isolation Gowns) | Predicate Device -
PRIMAGARD Isolation Gown
(AAMI PB70 level 3) | Comparison |
|-------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| FDA Classification Code | FYC | FYC | Identical |
| FDA Device Classification | Class II | Class II | Identical |
| Common Device Name | Surgical Isolation Gown | Surgical Isolation Gown | Identical |
| Trade Name | Halyard Tri-Layer AAMI 3
Isolation Gown | PRIMAGARD AAMI
PB70:2012 Level 3 Gown | Similar – the difference
of Trade Name has no
impact on the safety and
effectiveness of the
device itself. It allows
only for the User to
easily identify the
product. |
| Indications for Use | Halyard Tri-Layer AAMI 3
Isolation Gowns are
intended to be worn by
healthcare personnel in
isolation applications to
provide moderate barrier
protection for healthcare
personnel and patients from
microorganism transfer,
body fluids, and particulate
matter. The gowns are non-
sterile, single use, and meet
AAMI PB70:2012 level 3
Liquid Barrier performance
requirements. Not intended
for use in the operating
room. | PRIMAGARD Level 3 Isolation
Gowns are intended to be worn
by healthcare personnel in
isolation applications to provide
moderate barrier protection for
health care personnel and
patients from the transfer of
microorganisms, body fluids,
and particulate material. The
PRIMAGARD Isolation Gowns
of this 510(k) meet the
requirements of level 3 Liquid
Barrier Performance as per
AAMI PB70:2012 and are
provided non-sterile and are
single use only. | Both subject and
predicate device are
tested to be performant
to the same safety and
performance level as
required by AAMI
PB70:2012. |
| How the Device is Supplied | Bulk Non-Sterile | Bulk Non-Sterile | Identical |
| Sterilization Method | N/A | N/A | Identical |
| SAL | N/A | N/A | Identical |
| Gown Color | Blue | Blue, Yellow | Similar - Color options
do not materially impact
device safety or
performance |
| Attribute | Subject Device (Halyard
Tri-Layer AAMI 3
Isolation Gowns) | Predicate Device –
PRIMAGARD Isolation Gown
(AAMI PB70 level 3) | Comparison |
| Shelf-Life | 3 years | 5 years | Similar – both devices
are tested to be
performant over their
intended shelf life |
| Gown Sizes | Large, X-Large | Universal, X-Large | Similar – gown sizing
does not materially
impact device safety or
performance. |
| Construction Overview | The subject devices are
comprised of non-woven
fabrics, Spunbond /
Meltblown / Spunbond
(SMS) polypropylene. All
construction seams use
ultrasonic bonding as seam
closure method. | PRIMAGARD Level 3 Isolation
Gowns are made of SMS non
woven polypropylene material,
contain ultrasonic seams,
provide full coverage (level 3 as
per PB70) and are not made with
natural rubber latex. | Identical |
| Critical Zone | SMS Polypropylene | SMS Polypropylene | Identical |
| Not made with natural rubber
latex | True | True | Identical |
| ANSI/AAMI PB70: 2012
Level 3 Liquid Barrier
Requirements for Critical
Zone | Meets standard requirements
for Level 3 Liquid Barrier | Meets standard requirements for
Level 3 Liquid Barrier | Identical |
| Grab Tensile, Peak Stretch,
and Peak Energy Test | Tested to D5034 – Met
Acceptance Criteria | Tested to D5034 – Met
Acceptance Criteria | Identical |
| Tear Strength | Tested to ASTM D5587.
Met acceptance criteria | Tested to ASTM D5587.
Met acceptance criteria | Identical |
| Linting | EN ISO 9073-10 | Tested to NWSP
160.1.R0. Met acceptance
criteria | Similar – Both Standards
provide similar
reliability and predictive
power when determining
linting potential. |
| Seam Strength | ASTM D1683 | ASTM D5035 | ASTM D1683 methods
are more applicable to
the attribute being |
| Attribute | Subject Device (Halyard
Tri-Layer AAMI 3
Isolation Gowns) | Predicate Device –
PRIMAGARD Isolation Gown
(AAMI PB70 level 3) | Comparison |
| | | | verified. Thus, this
difference does not
imply dissimilarity in
performance with the
predicate device. |
| Heat Loss | Not Applicable | ASTM F1868 | This test is not
applicable to the
indication of use as
described above.
Therefore, its omission
does not impact safety,
performance, or
similarity to the
predicate device. |
| Water Vapor
Transmission | Not Applicable | Tested to ASTM E96. Met
acceptance criteria | This test is not
applicable to the
indication of use as
described above.
Therefore, its omission
does not impact safety,
performance, or
similarity to the
predicate device. |
| Air Permeability | Not Applicable | Tested to ASTM D737.
Met acceptance criteria | This test is not
applicable to the
indication of use as
described above.
Therefore, its omission
does not impact safety,
performance, or
similarity to the
predicate device. |
| Biocompatibility | ISO 10993:
Cytotoxicity
Sensitization
Irritation
Title device passed all
testing endpoints. | ISO 10993:
Cytotoxicity
Sensitization
Irritation
Title device passed all testing
endpoints. | Identical |
| Attribute | Subject Device (Halyard
Tri-Layer AAMI 3
Isolation Gowns) | Predicate Device -
PRIMAGARD Isolation Gown
(AAMI PB70 level 3) | Comparison |
| Liquid Barrier:
Hydrostatic Pressure | AATCC 127
$≥ 50 cm H2O$ | AATCC 127
$≥ 50 cm H2O$ | Identical |
| Liquid Barrier:
Impact Penetration | AATCC 42
$≤ 1.0g$ | AATCC 42
$≤ 1.0g$ | Identical |
7
Image /page/7/Picture/0 description: The image contains two company logos. The first logo is for Owens & Minor, and it features the letters "OM" in a stacked, maroon-colored design, followed by the company name in gray. The second logo is for Halyard, and it features a green and blue circular design with the company name in blue text.
8
Image /page/8/Picture/0 description: The image shows two company logos side by side. On the left is the Owens & Minor logo, featuring a stylized red emblem with horizontal lines and the text "Owens & Minor" in gray. To the right is the Halyard logo, which includes a blue circle containing a white and green abstract shape, followed by the word "HALYARD" in bold, blue letters.
9
Image /page/9/Picture/0 description: The image shows the logos of two companies, Owens & Minor and Halyard Health. The Owens & Minor logo is on the left and features a stylized red "OM" symbol next to the company name in gray. The Halyard Health logo is on the right and features a green and blue circular symbol next to the company name in blue.
Testing that supports the subject devices shows that the Halyard Tri-Layer AAMI 3 Isolation Gowns are similar to the predicate device PRIMAGARD Isolation Gown (AAMI PB70 level 3) (K160361) in design, intended use, sterility, and technological characteristics. The gowns meet the Level 3 AAMI PB70:2012 Liquid Barrier classification.
Summary of Non-Clinical Testing
| Test | Method | Acceptance
Criteria and
Sample Size
per lot | Result |
|-----------------------------------------------------|-------------------|------------------------------------------------------|--------|
| Spray Impact - Front/Back/Sleeve Panel | AATCC 42 | $≤$ 1.0g
n=35, c=3 | Pass |
| Spray Impact - Sleeve/Armhole Seam/Shoulder
Seam | AATCC 42 | $≤$ 1.0g
n=35, c=3 | Pass |
| Spray Impact - Front Tie | AATCC 42 | $≤$ 1.0g
n=35, c=3 | Pass |
| Static Decay MD | STM-00180 | USL 0.5s
n=36, c=0 | Pass |
| Static Decay CD | STM-00180 | USL 0.5s
n=36, c=0 | Pass |
| ISO L929 MEM Elution Cytotoxicity | ISO 10993-5:2009 | $≤$ Grade 2
(mild
reactivity) | Pass |
| ISO Irritation Test | ISO 10993-10:2010 | $≤$ 0.4
Primary
Irritation
(PII) | Pass |
| ISO Kligman Maximization Test | ISO 10993-10:2010 | Grade $