(105 days)
The 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 AAMI PB70:2012 Liquid Barrier classifications.
The Aero Blue Performance Surgical Gowns have a SMS/F/SMS design (Spunbond-Meltblown-Spunbond/Film/Spunbond-Meltblown-Spunbond) that provides a PB70:2012 Level 3 Liquid Barrier Performance Barrier in the critical zone. The back of the gown has a Spundbond-Meltblown-Spunbond (SMS) fabric which allows for air-breathability with an AAMI Level 1 Liquid Barrier Performance Barrier.
The Aero Blue Performance Surgical Gown is a single use gown, supplied sterile (via Ethylene Oxide) or as bulk non-sterile product. The gowns come in the following various sizes: Small, Large, X-Large, XX-Large, XXX-Large, X-Long XL, X-Long XXL.
Here's an analysis of the provided text regarding the acceptance criteria and study for the Aero Blue Performance Surgical Gowns:
The provided documentation describes the acceptance criteria and performance of a medical device (Aero Blue Performance Surgical Gowns) for a 510(k) premarket notification. This type of submission relies on demonstrating substantial equivalence to a legally marketed predicate device, rather than requiring a full de novo study proving efficacy and safety from scratch. Therefore, the "study" referred to is primarily a series of performance tests against established standards and a comparison to the predicate device.
1. Table of Acceptance Criteria and Reported Device Performance
Device: Aero Blue Performance Surgical Gowns (K192362)
| Test Method/Reference | Acceptance Criteria (Predicate Device) | Reported Device Performance (Subject Device - K192362) | Result |
|---|---|---|---|
| Spray Impact (Critical Zones) - AATCC 42 | Water Resistance - Pass | Water Resistance | Pass |
| Hydrostatic Pressure (Critical Zones) - AATCC 127 | Water Resistance - Pass | Water Resistance | Pass |
| Liquid Barrier Performance (Critical Zones) | ANSI/AAMI PB70:2012 Level 3 | ANSI/AAMI PB70:2012 Level 3 | Pass |
| Spray Impact (Non-Critical Zones) - AATCC 42 | Water Resistance - Pass | Water Resistance | Pass |
| Liquid Barrier Performance (Non-Critical Zones) | ANSI/AAMI PB70:2012 Level 1 | ANSI/AAMI PB70:2012 Level 1 | Pass |
| Grab Tensile, Peak Stretch, and Peak Energy - Nonwovens ASTM D5034 - 9 2017 | Tensile Strength - Pass | Tensile Strength | Pass |
| Abrasion Resistance of Nonwoven Fabrics NWSP 020.5.RO (15) 2015 | Abrasion Resistance - Pass | Abrasion Resistance | Pass |
| Synthetic Blood Penetration ASTM F1670 (2017) | Resistance to Penetration - Pass | Resistance to Penetration | Pass |
| Water Vapor Transmission Rate NWSP 070.4.RO (15) 2015 | Water Vapor Transmission - Pass | Water Vapor Transmission | Pass |
| 180 Degree Peel Strength of Non-Elastic Laminated Nonwovens STM-00197 Rev 1 | Peel Strength - Pass | Peel Strength | Pass |
| Linting ISO 9073-10 2003 | Particulate - Pass | Particulate | Pass |
| Flammability for Clothing Textiles 16 CFR 1610 | Flammability - Class 1 - Pass | Flammability | Pass |
| ISO L929 MEM Elution Cytotoxicity ISO 10993-5:2009 | Cytotoxicity - Pass (non-cytotoxic) | Cytotoxicity | Pass |
| ISO Indirect Primary Skin Irritation Test ISO 10993-10:2010 | Irritation - Pass (non-irritant) | Irritation | Pass |
| ISO Kligman Maximization Test ISO 10993-10:2010 | Sensitization - Pass (non-sensitizing) | Sensitization | Pass |
| EO Sterilization Residuals ISO 10993-7:2008 (R) 2012 | EO Residuals (EO=0.5mg/dev)(ECH =0.3mg/dev) - Pass | EO Residuals (EO=0.5mg/dev)(ECH =0.3mg/dev) | Pass |
| Laser Ignition Resistance ISO 11810-1:2015 | Laser Resistance - Pass | Laser Resistance | Pass |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the sample sizes for each specific test within the performance testing. However, given that these are performance tests for surgical gowns demonstrating compliance with industry standards (like AAMI PB70:2012 and various ISO/ASTM standards), the sample sizes would typically be determined by the requirements of those specific standards for each test (e.g., number of specimens for tensile strength, number of samples for barrier testing).
The data provenance is retrospective, as the tests were conducted on existing product designs to demonstrate substantial equivalence to a predicate device. The country of origin of the data is not specified, but the tests are based on internationally recognized standards (ISO, AAMI, ASTM, AATCC, CFR).
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
This type of submission (510(k) for surgical apparel) does not typically involve human expert adjudication of a test set in the way an AI diagnostic device would. The "ground truth" for these tests is established by:
- Industry standards and specifications: AAMI PB70:2012, ISO 9073-10, ASTM D5034, etc., define the criteria for what constitutes a "Pass" for each physical and material characteristic.
- Laboratory testing methodologies: Standardized laboratory procedures are followed to objectively measure the performance metrics (e.g., water resistance, tensile strength, biocompatibility).
Therefore, there isn't a stated number of experts or their qualifications for establishing a "ground truth" in the diagnostic sense, but rather adherence to established scientific and engineering principles and standards.
4. Adjudication Method for the Test Set
Not applicable. As explained above, this is about adherence to objective performance standards, not expert adjudication of diagnostic outcomes.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No. A MRMC comparative effectiveness study is designed to evaluate the impact of an AI system on human reader performance, typically in diagnostic imaging. This submission is for surgical gowns, which are physical barriers and do not involve diagnostic interpretation by human readers or AI.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
No. This concept is not applicable to a physical medical device like a surgical gown. The "standalone performance" is essentially the physical performance of the gown itself against the specified criteria, which is what the non-clinical tests assess.
7. The Type of Ground Truth Used
The ground truth used for the assessment of the surgical gowns' performance is based on established industry standards and regulatory requirements. This includes:
- Performance Standards: Specific liquid barrier classifications (AAMI PB70:2012 Level 3 and Level 1), tensile strength, abrasion resistance, synthetic blood penetration, water vapor transmission, peel strength, linting, flammability, laser resistance.
- Biocompatibility Standards: ISO 10993 series for cytotoxicity, irritation, and sensitization.
- Sterilization Standards: ISO 10993-7 for Ethylene Oxide residuals.
These standards define the objective criteria that the device must meet to be considered safe and effective for its intended use.
8. The Sample Size for the Training Set
Not applicable. Surgical gowns are physical products, not AI algorithms that require training data. The "training set" concept is irrelevant here.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for a physical device like a surgical gown.
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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" in a square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION".
December 13, 2019
O&M Halyard, Inc. Kimberly Lewis Senior Manager, Regulatory Affairs 9120 Lockwood Blvd Mechanicsville, Virginia 23116
Re: K192362
Trade/Device Name: Aero Blue Performance Surgical Gowns Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical apparel Regulatory Class: Class II Product Code: FYA Dated: August 29, 2019 Received: August 30, 2019
Dear Kimberly Lewis:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal
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542 of the Act); 21 CFR 1000-1050.
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 801and Part 809; 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 (QS) 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-
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 medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Elizabeth F. Claverie-Williams, MS Assistant Director. THT4B2: Disinfection Reprocessing and Personal Protection DHT4B: Division of Infection Control and Plastic Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known)
K192362
Device Name
Aero Blue Performance Surgical Gowns
Indications for Use (Describe)
The Aero Blue Performance Surgical gowns are steile, single use surgical apparel intended to be worn by healthcare professionals to help protect both the healthcate worker from the transfer of microorganisms, body fluuds, and particulate matter. The Aero Blue Performance Surgical Gowns meet the Level 3 AAMI PB70:2012 Liqud Barier classifications.
Non-Sterile Product Codes
| Product Code | Device Description | Gown Size |
|---|---|---|
| 41722NS | Aero Blue Performance Surgical Gown with Towel in Overwrap, L | Large |
| 41723NS | Aero Blue Performance Surgical Gown with Towel in Overwrap, XL | X-Large |
| 41725NS | Aero Blue Performance Surgical Gown, X-Long, L | X-Long, Large |
| 41727NS | Aero Blue Performance Surgical Gown, X-Long, XL | X-Long, X-Large |
| 41737NS | Aero Blue Performance Surgical Gown, L | Large |
| 41738NS | Aero Blue Performance Surgical Gown, XL | X-Large |
| 41739NS | Aero Blue Performance Surgical Gown, L | Large |
| 41740NS | Aero Blue Performance Surgical Gown, XL | X-Large |
| 41741NS | Aero Blue Performance Surgical Gown, XXL | XX-Large |
| 43623NS | Aero Blue Performance Surgical Gown, XXL, X-Long | X-Long, XX-Large |
| 43941NS | Aero Blue Performance Surgical Gown, S | Small |
| Sterile Product Codes | ||
| Product Code | Device Description | Gown Size |
| 41724 | Aero Blue Performance Surgical Gown, X-Long, L | X-Long, Large |
| 41726 | Aero Blue Performance Surgical Gown, X-Long, XL | X-Long, X-Large |
| 41732 | Aero Blue Performance Surgical Gown, S | Small |
| 41733 | Aero Blue Performance Surgical Gown, L | Large |
| 41734 | Aero Blue Performance Surgical Gown, XL | X-Large |
| 41735 | Aero Blue Performance Surgical Gown, XXL | XX-Large |
| 41736 | Aero Blue Performance Surgical Gown, XXXL | XXX-Large |
| 43938 | Aero Blue Performance Surgical Gown with Towel, X-Long, XXL | X-Long, XX-Large |
Type of Use (Select one or both, as applicable)
] Prescription Use (Part 21 CFR 801 Subpart D)
X Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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Expiration Date 06/30/2020
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Image /page/4/Picture/0 description: The image features two company logos side-by-side. On the left is the Owens & Minor logo, with a stylized "OM" in maroon and the company name in gray. To the right is the Halyard logo, which includes a green and white symbol resembling a stylized sail or upward-pointing arrow within a dark blue circle, followed by the company name "HALYARD" in dark blue, bold sans-serif font. The logos are positioned horizontally, suggesting a partnership or comparison between the two companies.
510(k) Summary
| 510(k)Number: | K192362 |
|---|---|
| DatePrepared: | November 19, 2019 |
| 510(k)Sponsor: | O&M Halyard Inc.9120 Lockwood BoulevardMechanicsville, VA 23116 |
| RegulatoryContact: | Kimberly Lewis5405 Windward Pkwy3rd Floor WestAlpharetta, GA 30004470-280-4388Kimberly.lewis@hyh.com |
| Device TradeName: | Aero Blue Performance Surgical Gowns |
| DeviceCommonName: | Surgical Gown |
| FDA DeviceProduct Code: | FYA |
| FDA DeviceClassification: | Class II |
| FDA DeviceName: | Gown, Surgical |
| FDARegulationNumber: | 21 CFR 878.4040 |
| PredicateDevice: | K140539 - Aero Blue Performance Surgical Gowns |
| DeviceDescription: | The Aero Blue Performance Surgical Gowns have a SMS/F/SMSdesign (Spunbond-Meltblown-Spunbond/Film/Spunbond- |
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Image /page/5/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 the company's initials in a stylized font, with the full name written out to the right. The Halyard Health logo is on the right and features a green and blue icon next to the company name in blue.
Meltblown-Spunbond) that provides a PB70:2012 Level 3 Liquid Barrier Performance Barrier in the critical zone. The back of the gown has a Spundbond-Meltblown-Spunbond (SMS) fabric which allows for air-breathability with an AAMI Level 1 Liquid Barrier Performance Barrier.
The Aero Blue Performance Surgical Gown is a single use gown, supplied sterile (via Ethylene Oxide) or as bulk non-sterile product. The gowns come in the following various sizes: Small, Large, X-Large, XX-Large, XXX-Large, X-Long XL, X-Long XXL.
Indications for
Use:
The Aero 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 AAMI PB70:2012 Liquid Barrier classifications.
| ProductCode | Device Description | Gown Size |
|---|---|---|
| Non-Sterile Product | ||
| 41722NS | Aero Blue Performance Surgical Gown withTowel in Overwrap, L | Large |
| 41723NS | Aero Blue Performance Surgical Gown withTowel in Overwrap, XL | X-Large |
| 41725NS | Aero Blue Performance Surgical Gown, X-Long,L | Large, X-Long |
| 41727NS | Aero Blue Performance Surgical Gown, X-Long,XL | X-Large, X-Long |
| 41737NS | Aero Blue Performance Surgical Gown, L | Large |
| 41738NS | Aero Blue Performance Surgical Gown, XL | X-Large |
| 41739NS | Aero Blue Performance Surgical Gown, L | Large |
| 41740NS | Aero Blue Performance Surgical Gown, XL | X-Large |
Product Codes Subject to this Premarket Notification
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Image /page/6/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 maroon emblem and the company name in gray. The Halyard logo is on the right, with a green and blue emblem and the company name in blue. The logos are placed side by side.
| 41741NS | Aero Blue Performance Surgical Gown, XXL | XX-Large |
|---|---|---|
| 43623NS | Aero Blue Performance Surgical Gown, XXL, X-Long | XXX-Large, X-Long |
| 43941NS | Aero Blue Performance Surgical Gown, S | Small |
| Sterile Product | ||
| 41724 | Aero Blue Performance Surgical Gown, X-Long,L | Large |
| 41726 | Aero Blue Performance Surgical Gown, X-Long,XL | X-Large, X-Long |
| 41732 | Aero Blue Performance Surgical Gown, S | Small |
| 41733 | Aero Blue Performance Surgical Gown, L | Large |
| 41734 | Aero Blue Performance Surgical Gown, XL | X-Large |
| 41735 | Aero Blue Performance Surgical Gown, XXL | XX-Large |
| 41736 | Aero Blue Performance Surgical Gown, XXXL | XXX-Large |
| 43938 | Aero Blue Performance Surgical Gown withTowel, X-Long, XXL | XX-Large, X-Long |
Technological Characteristic Comparison Table
| Attribute | Predicate Device (AeroBlue PerformanceSurgical Gowns,K140539) | Subject Device -K192362 | ComparisonAnalysis |
|---|---|---|---|
| FDAClassificationCode | FYA | FYA | Identical |
| FDA DeviceClassification | Class II | Class II | Identical |
| CommonDevice Name | Surgical Gown | Surgical Gown | Identical |
| Trade Name | Aero Blue PerformanceSurgical Gowns | Aero Blue PerformanceSurgical Gowns | Identical |
| Indications forUse | Aero Blue PerformanceSurgical Gowns are sterile,single use surgical apparelintended to be worn by | Aero Blue PerformanceSurgical Gowns aresterile, single use surgicalapparel intended to be | Similar |
| Attribute | Predicate Device (AeroBlue PerformanceSurgical Gowns,K140539) | Subject Device -K192362 | ComparisonAnalysis |
| healthcare professionals tohelp protect both thepatient and the healthcareworker from the transfer ofmicroorganisms, bodyfluids, and particulatematter.The Aero BluePerformance SurgicalGowns meet the Level 3AAMI PB70:2012 LiquidBarrier classifications.The Aero BluePerformance SurgicalGowns are also sold asbulk, non-sterile, single useitems torepackager/relabeler,establishments for furtherpackaging and EthyleneOxide (EO) sterilization. | worn by healthcareprofessionals to helpprotect both the patientand the healthcareworker from the transferof microorganisms, bodyfluids, and particulatematter.The Aero BluePerformance SurgicalGowns meet the Level 3AAMI PB70:2012 LiquidBarrier classifications. | ||
| How the Deviceis Supplied | Sterile or Bulk Non-Sterile | Sterile or Bulk Non-Sterile | Identical |
| SterilizationMethod | Ethylene Oxide | Ethylene Oxide | Identical |
| SAL | 10-6 | 10-6 | Identical |
| Gown Color | Blue | Blue | Identical |
| Gown Sizes | Small, Large, X-Large,XX-Large, XXX-Large | Small, Large, X-Large,XX-Large, XXX-Large,X-Long XL, X-LongXXL | Similar |
| ConstructionOverview | The Aero BluePerformance SurgicalGown is manufacturedfrom a moisture-vaporbreathable, repellent, non-woven fabric using apolymer blend ofpolypropylene andpolyethylene. The front | The Aero BluePerformance SurgicalGown is manufacturedfrom a moisture-vaporbreathable, transmitting,non-woven fabric using apolymer blend ofpolypropylene andplastomer. The front | Similar |
| Attribute | Predicate Device (AeroBlue PerformanceSurgical Gowns, K140539) | Subject Device -K192362 | ComparisonAnalysis |
| body and sleeve fabric is athree layer film laminate.This fabric is an SFSMSdesign(Spunbond/Film/Spunbond-Meltblown-Spunbond)that is adhesively bondedtogether. The film itself isa multi-layerpolypropylene-based vaporbreathable membrane thatuses Calcium Carbonate(CaCO3) filler to createmicropores to allow vaportransmission across themembrane. A polyolefinhot melt adhesive is used tolaminate the facing layersto the film layer tocomplete the composite.Sleeves in the gown areclosed with a heat sealingprocess to meet AAMI-3liquid barrier requirements.The back of the gown (inthe non-critical zone) iscomposed of a breathableSMS fabric with an AAMI1 liquid barrier protection. | body and sleeve fabricare a three layer filmlaminate. This fabric isan SMS/F/SMS design(Spunbond-Meltblown-Spunbond/Film/Spunbond-Meltblown-Spunbond)that is adhesively bondedtogether. The film itselfis a multi-layerpolyethylene-based vaporbreathable membranethat uses CalciumCarbonate (CaCO3) fillerto create micropores toallow vapor transmissionacross the membrane. Apolyolefin hot meltadhesive is used tolaminate the facing layersto the film layer tocomplete the composite.Sleeves in the gown areclosed with a heat sealingprocess to meet AAMI-3liquid barrierrequirements. The backof the gown (in the non-critical zone) iscomposed of a breathableSMS fabric with anAAMI 1 liquid barrierprotection. | ||
| Does notcontain naturalrubber latex | Yes | Yes | Identical |
| Predicate Device (Aero BluePerformance Surgical Gowns,K140539) | Subject Device | ComparisonAnalysis | |
| ANSI/AAMI PB70: 2012 Level 3Liquid Barrier Requirements forCritical Zone - Pass | ANSI/AAMI PB70: 2012 Level 3Liquid Barrier Requirements forCritical Zone - Pass | Identical | |
| ANSI/AAMI PB70: 2012 Level 1Liquid Barrier Requirements forNon-Critical Zone - Pass | ANSI/AAMI PB70: 2012 Level 1Liquid Barrier Requirements forNon-Critical Zone - Pass | Identical | |
| Biocompatibility per ISO 10993 –Pass the device under theconditions of the study is non-cytotoxic, non-irritant, and non-sensitizing | Biocompatibility per ISO 10993 –Pass the device under theconditions of the study is non-cytotoxic, non-irritant, and non-sensitizing | Identical | |
| Water Vapor Transmission Rate ofMaterials (MOCON) - Pass | Water Vapor Transmission Rate ofMaterials (MOCON) - Pass | Similar | |
| Linting per ISO 9073-10 - Pass | Linting per ISO 9073-10 - Pass | Similar | |
| Standard Test Method for BreakingStrength and Elongation of TextileFabrics per ASTM D5034 - Pass | Standard Test Method forBreaking Strength and Elongationof Textile Fabrics per ASTMD5034 - Pass | Similar | |
| Peel Strength per STM-00197 -Pass | Peel Strength per STM-00197 -Pass | Similar | |
| Hydrohead Testing – Pass | Hydrohead Testing – Pass | Similar | |
| Abrasion Testing per STM-00149 -Pass | Abrasion Testing per STM-00149 -Pass | Similar | |
| 16 CFR, Chapter II – ConsumerProduct Safety Commission Part1610 – Standard for theFlammability of Clothing TextilesClass 1 - Pass | 16 CFR, Chapter II – ConsumerProduct Safety Commission Part1610 – Standard for theFlammability of Clothing TextilesClass 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 | |
| Test Method/Reference | AcceptanceCriteria | Results | |
| Spray Impact (CriticalZones) | AATCC 42 | Water Resistance | Pass |
| Hydrostatic Pressure(Critical Zones) | AATCC 127 | Water Resistance | Pass |
| Liquid Barrier Performance | ANSI/AAMIPB70:2012 Level 3 | Water Resistance | Pass |
| Spray Impact (Non-CriticalZones) | AATCC 42 | Water Resistance | Pass |
| Liquid Barrier Performance | ANSI/AAMIPB70:2012 Level 1 | Water Resistance | Pass |
| Grab Tensile, Peak Stretch,and Peak Energy -Nonwovens | ASTM D5034 - 92017 | Tensile Strength | Pass |
| Abrasion Resistance ofNonwoven Fabrics | NWSP 020.5.RO(15) 2015 | Abrasion Resistance | Pass |
| Synthetic Blood Penetration | ASTM F1670(2017) | Resistance toPenetration | Pass |
| Water Vapor TransmissionRate | NWSP 070.4.RO(15) 2015 | Water VaporTransmission | Pass |
| 180 Degree Peel Strengthof Non-Elastic LaminatedNonwovens | STM-00197 Rev 1 | Peel Strength | Pass |
| Linting | ISO 9073-102003 | Particulate | Pass |
| Standard for theFlammability for ClothingTextiles | 16 CFR 1610 | Flammability | Pass |
| ISO L929 MEM ElutionCytotoxicity | ISO 10993-5:2009 | Cytotoxicity | Pass |
| ISO Indirect Primary SkinIrritation Test | ISO 10993-10:2010 | Irritation | Pass |
| ISO Kligman MaximizationTest | ISO 10993-10:2010 | Sensitization | Pass |
| EO Sterilization Residuals | ISO 10993-7:2008 (R) 2012 | EO Residuals(EO=0.5mg/dev)(ECH =0.3mg/dev) | Pass |
| Laser Ignition Resistance | ISO 11810-1:2015 | Laser Resistance | Pass |
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Image /page/7/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 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 Health logo is on the right and consists of a green and blue stylized image of a house, with the word "HALYARD" in a bold, blue font to the right.
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Image /page/8/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 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 Health logo is on the right and consists of a green and blue stylized image of a house, with the word "HALYARD" in a bold, blue font to the right.
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Image /page/9/Picture/0 description: The image shows the logos of two companies. The first logo is for Owens & Minor, a healthcare logistics company, and it features the letters "OM" in a stylized font. The second logo is for Cardinal Health, a healthcare services company, and it features a blue circle with a white and green mountain design inside.
Halyard
Performance Testing
Testing conducted to support the changes of subject device shows that the Aero Blue Performance Surgical Gown is similar to the predicate device Aero Blue Performance Surgical Gown (K140539) in design, intended use, sterility, and technological characteristics. In the critical zone, the Aero Blue Performance Surgical Gowns meet the Level 3 AAMI PB70:2012 Liquid Barrier classification. The back of the gown meets the Level 1 AAMI PB70:2012 Liquid Barrier classification.
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Image /page/10/Picture/0 description: The image shows 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 running through them, accompanied by the company name in a smaller, gray font. The second logo is for Halyard, consisting of a blue circle with a white, stylized shape inside, partially filled with green, followed by the company name in a bold, blue font.
Summary of Non-Clinical Testing
Conclusion
The conclusions drawn from the non-clinical tests demonstrate that the subject device is as safe, as effective and performs as well as or better than the legally marketed predicate device.
§ 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.