(245 days)
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.
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.
The provided document details the non-clinical testing performed on the Halyard Tri-Layer AAMI 3 Isolation Gowns to demonstrate their substantial equivalence to a predicate device.
1. Table of Acceptance Criteria and Reported Device Performance:
| Test | Method | Acceptance Criteria | Reported Device Performance |
|---|---|---|---|
| Spray Impact - Front/Back/Sleeve Panel | AATCC 42 | ≤ 1.0g | Pass |
| Spray Impact - Sleeve/Armhole Seam/Shoulder Seam | AATCC 42 | ≤ 1.0g | Pass |
| Spray Impact - Front Tie | AATCC 42 | ≤ 1.0g | Pass |
| Static Decay MD | STM-00180 | USL 0.5s | Pass |
| Static Decay CD | STM-00180 | USL 0.5s | 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 < 1 | Pass |
| Grab Strength MD | ASTM D5034 | LSL 44N (One-sided 95/95 tolerance limit, K-factor 2.309) | Pass |
| Grab Strength CD | ASTM D5034 | LSL 44N (One-sided 95/95 tolerance limit, K-factor 2.309) | Pass |
| Tear Strength MD | ASTM D5733 | LSL 10N (One-sided 95/95 tolerance limit, K-factor 2.309) | Pass |
| Tear Strength CD | ASTM D5733 | LSL 10N (One-sided 95/95 tolerance limit, K-factor 2.309) | Pass |
| Hydrostatic Pressure - Front/Back/Sleeve/Panel | AATCC 127 | ≥ 50 cmH2O | Pass |
| Hydrostatic Pressure - Sleeve/Armhole Seam/Shoulder Seam | AATCC 127 | ≥ 50 cmH2O | Pass |
| Hydrostatic Pressure – Front Tie | AATCC 127 | ≥ 50 cmH2O | Pass |
| Basis Weight (Baseline Only) | ASTM D3776 | LSL 32.4 USL 39.6 (Two-sided 95/93.5 tolerance limit, K-factor 2.654) | Pass |
| Flammability MD (Baseline Only) | CFR 1610 | Class 1, ≤3.5s | Pass |
| Flammability CD (Baseline Only) | CFR 1610 | Class 1, ≤3.5s | Pass |
| Seam Strength - Sleeve Seam | ASTM D1683 | LSL 30N (One-sided 95/95 tolerance limit, K-factor 2.309) | Pass |
| Seam Strength - Armhole Seam | ASTM D1683 | LSL 30N (One-sided 95/95 tolerance limit, K-factor 2.309) | Pass |
| Lint Generation - SMS | EN ISO 9073-10 | Log10 (lint count) ≤ 4.0 | Pass |
2. Sample Sizes Used for the Test Set and Data Provenance:
The sample sizes for the test sets are indicated for each test in the acceptance criteria table. For example, for Spray Impact (AATCC 42) and Hydrostatic Pressure (AATCC 127), the sample size is n=35 with c=3. For Static Decay (STM-00180), the sample size is n=36 with c=0. For Grab Strength and Tear Strength (ASTM D5034, D5733, D1683), the sample size is n=24 for a one-sided 95/95 tolerance limit. For Flammability (CFR 1610), the sample size is n=49 with c=0. For Lint Generation (EN ISO 9073-10), the sample size is n=30.
The document does not specify the country of origin of the data or whether the data is retrospective or prospective.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
Not applicable. This is a submission for an isolation gown, and the testing involves laboratory measurements against established physical and material standards, not expert clinical evaluation for a diagnostic or AI device.
4. Adjudication Method for the Test Set:
Not applicable. The tests are laboratory-based and measure physical properties against defined standards.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
Not applicable. This is not an AI-enabled device.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. This is not an AI-enabled device.
7. The Type of Ground Truth Used:
The "ground truth" for the performance of the isolation gowns is based on established industry and international standards for protective apparel (e.g., AAMI PB70:2012, AATCC, ASTM, ISO standards). The device's physical and material properties are directly measured and compared against the predefined acceptance criteria within these standards.
8. The Sample Size for the Training Set:
Not applicable. This is a physical medical device, not an AI/machine learning algorithm that requires a training set.
9. How the Ground Truth for the Training Set Was Established:
Not applicable. There is no training set as this is not an AI/machine learning algorithm.
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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"
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(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
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OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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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 |
|---|---|
| DatePrepared: | May 16, 2024 |
| 510(k)Sponsor: | O&M Halyard Inc.9120 Lockwood BoulevardMechanicsville, VA 23116 |
| RegulatoryContact: | Gabriel Dockery1 Edison DriveAlpharetta, GA 30005470-280-4388Gabriel.dockery@hyh.com |
| Device TradeNames: | Halyard Tri-Layer AAMI 3 Isolation Gowns |
| Device CommonName: | Isolation Gown |
| FDA DeviceProduct Code: | FYC |
| FDA DeviceClassification: | Class II |
| FDA DeviceName: | Gown, Isolation, Surgical |
| FDARegulationNumber: | 21 CFR 878.4040 |
| PredicateDevice: | K160361 – PRIMAGARD AAMI PB70:2012 Level 3 gowns |
Device Descriptions:
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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 forUse forHalyard Tri-Layer AAMI 3IsolationGowns : | Halyard Tri-Layer AAMI 3 Isolation Gowns are intended to be wornby healthcare personnel in isolation applications to provide moderatebarrier protection for healthcare personnel and patients frommicroorganism transfer, body fluids, and particulate matter. Thegowns are non-sterile, single use, and meet AAMI PB70:2012 level3 Liquid Barrier performance requirements. Not intended for use inthe 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
| ProductCode | 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 (HalyardTri-Layer AAMI 3Isolation 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 3Isolation Gown | PRIMAGARD AAMIPB70:2012 Level 3 Gown | Similar – the differenceof Trade Name has noimpact on the safety andeffectiveness of thedevice itself. It allowsonly for the User toeasily identify theproduct. |
| Indications for Use | Halyard Tri-Layer AAMI 3Isolation Gowns areintended to be worn byhealthcare personnel inisolation applications toprovide moderate barrierprotection for healthcarepersonnel and patients frommicroorganism transfer,body fluids, and particulatematter. The gowns are non-sterile, single use, and meetAAMI PB70:2012 level 3Liquid Barrier performancerequirements. Not intendedfor use in the operatingroom. | PRIMAGARD Level 3 IsolationGowns are intended to be wornby healthcare personnel inisolation applications to providemoderate barrier protection forhealth care personnel andpatients from the transfer ofmicroorganisms, body fluids,and particulate material. ThePRIMAGARD Isolation Gownsof this 510(k) meet therequirements of level 3 LiquidBarrier Performance as perAAMI PB70:2012 and areprovided non-sterile and aresingle use only. | Both subject andpredicate device aretested to be performantto the same safety andperformance level asrequired by AAMIPB70:2012. |
| 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 optionsdo not materially impactdevice safety orperformance |
| Attribute | Subject Device (HalyardTri-Layer AAMI 3Isolation Gowns) | Predicate Device –PRIMAGARD Isolation Gown(AAMI PB70 level 3) | Comparison |
| Shelf-Life | 3 years | 5 years | Similar – both devicesare tested to beperformant over theirintended shelf life |
| Gown Sizes | Large, X-Large | Universal, X-Large | Similar – gown sizingdoes not materiallyimpact device safety orperformance. |
| Construction Overview | The subject devices arecomprised of non-wovenfabrics, Spunbond /Meltblown / Spunbond(SMS) polypropylene. Allconstruction seams useultrasonic bonding as seamclosure method. | PRIMAGARD Level 3 IsolationGowns are made of SMS nonwoven polypropylene material,contain ultrasonic seams,provide full coverage (level 3 asper PB70) and are not made withnatural rubber latex. | Identical |
| Critical Zone | SMS Polypropylene | SMS Polypropylene | Identical |
| Not made with natural rubberlatex | True | True | Identical |
| ANSI/AAMI PB70: 2012Level 3 Liquid BarrierRequirements for CriticalZone | Meets standard requirementsfor Level 3 Liquid Barrier | Meets standard requirements forLevel 3 Liquid Barrier | Identical |
| Grab Tensile, Peak Stretch,and Peak Energy Test | Tested to D5034 – MetAcceptance Criteria | Tested to D5034 – MetAcceptance 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 NWSP160.1.R0. Met acceptancecriteria | Similar – Both Standardsprovide similarreliability and predictivepower when determininglinting potential. |
| Seam Strength | ASTM D1683 | ASTM D5035 | ASTM D1683 methodsare more applicable tothe attribute being |
| Attribute | Subject Device (HalyardTri-Layer AAMI 3Isolation Gowns) | Predicate Device –PRIMAGARD Isolation Gown(AAMI PB70 level 3) | Comparison |
| verified. Thus, thisdifference does notimply dissimilarity inperformance with thepredicate device. | |||
| Heat Loss | Not Applicable | ASTM F1868 | This test is notapplicable to theindication of use asdescribed above.Therefore, its omissiondoes not impact safety,performance, orsimilarity to thepredicate device. |
| Water VaporTransmission | Not Applicable | Tested to ASTM E96. Metacceptance criteria | This test is notapplicable to theindication of use asdescribed above.Therefore, its omissiondoes not impact safety,performance, orsimilarity to thepredicate device. |
| Air Permeability | Not Applicable | Tested to ASTM D737.Met acceptance criteria | This test is notapplicable to theindication of use asdescribed above.Therefore, its omissiondoes not impact safety,performance, orsimilarity to thepredicate device. |
| Biocompatibility | ISO 10993:CytotoxicitySensitizationIrritationTitle device passed alltesting endpoints. | ISO 10993:CytotoxicitySensitizationIrritationTitle device passed all testingendpoints. | Identical |
| Attribute | Subject Device (HalyardTri-Layer AAMI 3Isolation 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 |
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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.
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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.
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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 | AcceptanceCriteria andSample Sizeper lot | Result |
|---|---|---|---|
| Spray Impact - Front/Back/Sleeve Panel | AATCC 42 | $≤$ 1.0gn=35, c=3 | Pass |
| Spray Impact - Sleeve/Armhole Seam/ShoulderSeam | AATCC 42 | $≤$ 1.0gn=35, c=3 | Pass |
| Spray Impact - Front Tie | AATCC 42 | $≤$ 1.0gn=35, c=3 | Pass |
| Static Decay MD | STM-00180 | USL 0.5sn=36, c=0 | Pass |
| Static Decay CD | STM-00180 | USL 0.5sn=36, c=0 | Pass |
| ISO L929 MEM Elution Cytotoxicity | ISO 10993-5:2009 | $≤$ Grade 2(mildreactivity) | Pass |
| ISO Irritation Test | ISO 10993-10:2010 | $≤$ 0.4PrimaryIrritation(PII) | Pass |
| ISO Kligman Maximization Test | ISO 10993-10:2010 | Grade $<$ 1 | Pass |
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Image /page/10/Picture/0 description: The image shows the logo for Owens & Minor. The logo consists of two parts: a stylized "OM" in a dark red color and the words "Owens & Minor" in gray. The "OM" is made up of several horizontal lines, giving it a modern and abstract look.
D
| Grab Strength MD | ASTM D5034 | LSL 44NOne-sided95/95tolerance limit,K-factor2.309, n=24 | Pass |
|---|---|---|---|
| Grab Strength CD | ASTM D5034 | LSL 44NOne-sided95/95tolerance limit,K-factor2.309, n=24 | Pass |
| Tear Strength MD | ASTM D5733 | LSL 10NOne-sided95/95tolerance limit,K-factor2.309, n=24 | Pass |
| Tear Strength CD | ASTM D5733 | LSL 10NOne-sided95/95tolerance limit,K-factor2.309, n=24 | Pass |
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Image /page/11/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 and the company name in gray. To the right is the Halyard logo, which includes a green and blue icon resembling a stylized upward arrow, followed by the company name in blue.
| Hydrostatic Pressure - Front/Back/Sleeve/Panel | AATCC 127 | ≥ 50 cmH2On=35, c=3 | Pass |
|---|---|---|---|
| Hydrostatic Pressure - Sleeve/ArmholeSeam/Shoulder Seam | AATCC 127 | ≥ 50 cmH2On=35, c=3 | Pass |
| Hydrostatic Pressure – Front Tie | AATCC 127 | ≥ 50 cmH2On=35, c=3 | Pass |
| Basis Weight(Baseline Only) | ASTM D3776 | LSL 32.4USL39.6Two-sided95/93.5tolerance limit,K-factor2.654,n=18 | Pass |
| Flammability MD (Baseline Only) | CFR 1610 | Class 1, ≤3.5sn=49, c=0 | Pass |
| Flammability CD (Baseline Only) | CFR 1610 | Class 1, ≤3.5sn=49, c=0 | Pass |
| Seam Strength - Sleeve Seam | ASTM D1683 | LSL 30NOne-sided95/95tolerancelimit,K-factor2.309, n=24 | Pass |
| Seam Strength - Armhole Seam | ASTM D1683 | LSL 30NOne-sided95/95tolerancelimit,K-factor2.309, n=24 | Pass |
| Lint Generation - SMS | EN ISO 9073-10 | Log10 (lintcount) ≤ 4,0n=30 | Pass |
Summary of Clinical Testing
N/A.
Conclusion
The conclusions drawn from the non-clinical tests demonstrate that the Halyard Tri-Layer AAMI 3 Isolation Gowns are as safe, as effective, and perform as well as or better than the K160361 – PRIMAGARD AAMI PB70:2012 Level 3 gowns.
§ 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.