(135 days)
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.
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.
The provided document describes the acceptance criteria and performance data for surgical gowns, not a medical device that uses algorithms or AI. Therefore, most of the requested information (sample sizes for test and training sets, data provenance, expert qualifications, adjudication methods, MRMC studies, standalone algorithm performance, and ground truth establishment for training) is not applicable.
Below is a table summarizing the acceptance criteria and reported performance based on the non-clinical testing for the AERO CHROME* Select Breathable Performance Surgical Gown and AERO CHROME* A-Line Breathable Performance Surgical Gown.
1. Table of Acceptance Criteria and Reported Device Performance
| Test Method (Standard/Reference) | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Liquid Barrier Performance | ||
| ANSI/AAMI PB70:2012 Level 4 (Critical Zone) | Resistance to Penetration by Blood-Borne Pathogens Using Phi-X174 Bacteriophage | Pass |
| ANSI/AAMI PB70:2012 Level 1 | Meets standard requirements for Level 1 Liquid Barrier | Pass |
| Synthetic Blood Penetration ASTM F1670 (2017) | Meets standard requirements for ASTM F1670 (2017) | Pass |
| Material Strength and Durability | ||
| Grab Tensile, Peak Stretch, and Peak Energy - Nonwovens ASTM D5034 - 9 2017 | Meets standard requirements for ASTM D5034 -9 2017 | Pass |
| Abrasion Resistance of Nonwoven Fabrics NWSP 020.5.RO (15) 2015 | Meets requirements of standard NWSP 020.5.RO (15) 2015 | Pass |
| Standard Test Method for Breaking Strength and Elongation of Textile Fabrics per ASTM D5034 | Pass (Identical to predicate) | Pass |
| Peel Strength per STM-00197 | LSL: >125 grams | Pass |
| Hydrohead Testing | Pass (Identical to predicate) | Pass |
| Abrasion Testing per STM-00149 | Pass (Identical to predicate) | Pass |
| Material Breathability/Particles | ||
| Water Vapor Transmission Rate NWSP 070.4.RO (15) 2015 | Meets standard requirements for NWSP 070.4.RO (15) 2015 | Pass |
| Water Vapor Transmission Rate of Materials (MOCON) | Pass (Identical to predicate) | Pass |
| Linting ISO 9073-10 2003 | Meets requirement for ISO 9073-10 2003 | Pass |
| Linting per ISO 9073-10 | Pass (Identical to predicate) | Pass |
| Air Permeability (Back of Gown) per STM-00162, NWSP 070.1.RO | Pass (Similar to predicate) | Pass |
| Biocompatibility & Safety | ||
| ISO L929 MEM Elution Cytotoxicity ISO 10993-5:2009 | < Grade 2 | Pass |
| ISO Indirect Primary Skin Irritation Test ISO 10993-10:2010 | (mild reactivity) | Pass |
| ISO Kligman Maximization Test ISO 10993-10:2010 | < 0.4 | Pass |
| Biocompatibility per ISO 10993 | Device under the conditions of the study is non-cytotoxic, non-irritant, and non-sensitizing | Pass |
| Flammability 16 CFR 1610 (Clothing Textiles) | Meets Class 1 requirements | Pass |
| 16 CFR, Chapter II - Consumer Product Safety Commission Part 1610 | Class 1 - Pass (Identical to predicate) | Pass |
| Laser Ignition Resistance ISO 11810-1:2015 | Class 1 rating No ignition | Pass |
| EO Sterilization Residuals ISO 109937-7:2008 (R) 2012 | Meet EO Residual requirements per ISO 1099370-7:200(R) 12 | Pass |
The remaining information requested is not provided in the document, as it pertains to AI/algorithmic medical devices, which these surgical gowns are not. The document describes a 510(k) submission for conventional surgical apparel and relies on established performance standards for such products.
N/A for algorithmic/AI devices:
- Sample size used for the test set and the data provenance: N/A (not an AI device)
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: N/A (not an AI device)
- Adjudication method for the test set: N/A (not an AI device)
- 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: N/A (not an AI device)
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: N/A (not an AI device)
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.): N/A (not an AI device; ground truth is based on physical material testing standards)
- The sample size for the training set: N/A (not an AI device)
- How the ground truth for the training set was established: N/A (not an AI device)
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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 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
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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
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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.
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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 |
|---|---|
| DatePrepared: | March 05, 2021 |
| 510(k)Sponsor: | O&M Halyard Inc.9120 Lockwood BoulevardMechanicsville, VA 23116 |
| RegulatoryContact: | Steven Dowdley1 Edison DriveAlpharetta, GA 30005678-451-8062Steven.dowdley@hyh.com |
| Device TradeNames: | AERO CHROME* Select Breathable Performance Surgical Gowns AEROCHROME* A-Line Breathable Performance Surgical Gowns |
| DeviceCommonName: | Surgical Gown |
| FDA DeviceProduct Code: | FYA |
| FDA DeviceClassification: | Class II |
| FDA DeviceName: | Gown, Surgical |
| FDARegulationNumber: | 21 CFR 878.4040 |
| Predicate | K200522 – AERO CHROME* Breathable Performance Surgical Gowns |
| Device | |
| Descriptions: | The AERO CHROME* Select Breathable Performance Surgical Gownshave a SMS/F/SMS design (Spunbond-Meltblown-Spunbond/Film/Spunbond-Meltblown-Spunbond) that provides aPB70:2012 Level 4 Liquid Barrier Performance Barrier in the criticalzone. The back of the gown is comprised of the identical fabric as thefront of the gown and meets AAMI Level 1 Liquid Barrier PerformanceBarrier. |
| The AERO CHROME* Select Breathable Performance Surgical Gown is asingle 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 Gownshave a SMS/F/SMS design (Spunbond-Meltblown-Spunbond/Film/Spunbond-Meltblown-Spunbond) that provides aPB70:2012 Level 4 Liquid Barrier Performance Barrier in the criticalzone. The back of the gown is lightweight, air-breathable, and providesAAMI Level 1 protection. | |
| The AERO CHROME* A-Line Breathable Performance Surgical Gown is asingle use gown, supplied sterile (via Ethylene Oxide) or as bulk non-sterile product. The gowns come in an X-Long, X- Large size. | |
| Indications forUse for AEROCHROME*SelectBreathablePerformanceSurgicalGowns: | The AERO CHROME* Select Breathable Performance Surgical Gowns aresterile, single use surgical apparel intended to be worn by healthcareprofessionals to help protect both the patient and the healthcare workerfrom the transfer of micro-organisms, body fluids, and particulate matter.The AERO CHROME* Select Breathable Performance Surgical Gowns meetthe Level 4 AAMI PB70:2012 Liquid Barrier classifications. |
| Indications forUse for AEROCHROME* A-LineBreathablePerformanceSurgicalGowns: | The AERO CHROME* A-Line Breathable Performance Surgical Gowns aresterile, single use surgical apparel intended to be worn by healthcareprofessionals to help protect both the patient and the healthcare workerfrom the transfer of micro-organisms, body fluids, and particulate matter.The AERO CHROME* A-Line Breathable Performance Surgical Gownsmeet the Level 4 AAMI PB70:2012 Liquid Barrier classifications. |
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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.
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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
| ProductCode | 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*BreathablePerformance SurgicalGown, K200522) | Subject Device –AERO CHROME*Select BreathablePerformance SurgicalGowns, K210688 | Subject Device – AEROCHROME* A-Line BreathablePerformance SurgicalGowns, K210688 | ComparisonAnalysis |
|---|---|---|---|---|
| FDAClassificationCode | FYA | FYA | FYA | Identical |
| FDA DeviceClassification | Class II | Class II | Class II | Identical |
| Common DeviceName | Surgical Gown | Surgical Gown | Surgical Gown | Identical |
| Trade Name | AERO CHROME*BreathablePerformance SurgicalGown | AERO CHROME*Select BreathablePerformance SurgicalGown | AERO CHROME* A-Line BreathablePerformance SurgicalGown | Similar |
| Indications forUse | AERO CHROME*BreathablePerformance SurgicalGowns are sterile,single use surgicalapparel intended to beworn by healthcareprofessionals | AERO CHROME*Select BreathablePerformance SurgicalGowns are sterile, singleuse surgical apparelintended to be worn byhealthcare professionals | AERO CHROME* A-Line BreathablePerformance SurgicalGowns are sterile, singleuse surgical apparelintended to be worn byhealthcare professionals | Identical |
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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 PerformanceSurgical Gown, K200522) | Subject Device -AERO CHROME*Select BreathablePerformance SurgicalGowns, K210688 | Subject Device – AEROCHROME* A-Line BreathablePerformance SurgicalGowns, K210688 | ComparisonAnalysis |
|---|---|---|---|---|
| to help protect both thepatient and thehealthcare worker fromthe transfer ofmicroorganisms, bodyfluids, and particulatematter. The AEROCHROME* BreathablePerformance SurgicalGowns meet the Level 4AAMI PB70 Liquid Barrierclassifications | to help protect both thepatient and thehealthcare worker fromthe transfer ofmicroorganisms, bodyfluids, and particulatematter. The AEROCHROME* SelectBreathable PerformanceSurgical Gowns meet theLevel 4 AAMI PB70 LiquidBarrier classifications. | to help protect both thepatient and thehealthcare worker fromthe transfer ofmicroorganisms, bodyfluids, and particulatematter. The AEROCHROME* A-LineBreathable PerformanceSurgical Gowns meet theLevel 4 AAMI PB70 LiquidBarrier classifications. | ||
| How theDevice isSupplied | Sterile or Bulk Non-Sterile | Sterile or Bulk Non-Sterile | Sterile | Similar |
| SterilizationMethod | 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-LongXL, X-Long XXL | Large, X-Large, XX-Large | X-Long XL | Similar |
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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-structionOverview | The AERO CHROME*Breathable PerformanceSurgical Gown ismanufactured from amoisture-vaporbreathable, non-wovenfabric using a polymerblend of polypropyleneand plastomer. The frontbody and sleeve fabric area three-layer filmlaminate. This fabric is anSMS/F/SMS design that isadhesively bondedtogether. The film itself isa multi-layerpolypropylene/plastomer, | The AERO CHROME*Select BreathablePerformance SurgicalGown is manufacturedfrom a moisture-vaporbreathable, non-wovenfabric using a polymerblend of polypropyleneand plastomer. The frontbody and sleeve fabricare a three-layer filmlaminate. This fabric is anSMS/F/SMS design that isadhesively bondedtogether. The film itselfis a multi-layerpolypropylene/plastomer, | The AERO CHROME*A-Line BreathablePerformance SurgicalGown is manufacturedfrom a moisture-vaporbreathable, non-wovenfabric using a polymerblend of polypropyleneand plastomer. The frontbody and sleeve fabricare a three-layer filmlaminate. This fabric is anSMS/F/SMS design that isadhesively bondedtogether. The film itselfis a multi-layerpolypropylene/plastomer, | Select Gown- SimilarA-LineGown -Identical |
|---|---|---|---|---|
| ------------------------------- | ----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ | --------------------------------------------------------------- |
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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*BreathablePerformance SurgicalGown, K200522) | Subject Device –AERO CHROME*Select BreathablePerformance SurgicalGowns, K210688 | Subject Device – AEROCHROME* A-Line BreathablePerformance SurgicalGowns, K210688 | Comparison Analysis |
|---|---|---|---|---|
| CaCO3 filled, grey film.The polyolefin hot meltadhesive is used tolaminate the facing layersto the film layer tocomplete the composite.Sleeves of the gown areclosed with a heat-sealing process to meetAAMI-4 liquid barrierrequirements. The backof the AERO CHROME*Breathable PerformanceSurgical Gown in thenon-critical zone iscomposed of 1.2osy SMS fabric withan AAMI level 1liquid barrierprotection. | CaCO3 filled, grey film.The polyolefin hot meltadhesive is used tolaminate the facing layersto the film layer tocomplete the composite.Sleeves of the gown areclosed with a heat-sealing process to meetAAMI-4 liquid barrierrequirements. Theidentical material thatcomprises the front ofthe gown also comprisesthe back of the gown inone continuous material.Therefore, this gowndoes not have sideseams. | CaCO3 filled, grey film.The polyolefin hot meltadhesive is used tolaminate the facing layersto the film layer tocomplete the composite.Sleeves of the gown areclosed with a heat-sealing process to meetAAMI-4 liquid barrierrequirements. The backof the AERO CHROME*A-Line BreathablePerformance SurgicalGown in the non-criticalzone is composed of 1.2osy SMS fabric with anAAMI level 1 liquidbarrier protection. | ||
| Does notcontainnatural rubberlatex | Yes | Yes | Yes | Identical |
Performance Testing
| Predicate Device -AERO CHROME* BreathablePerformance Surgical Gowns, K200522 | Subject Devices - AERO CHROME* SelectBreathable Performance Surgical Gownsand AERO CHROME* A-Line BreathablePerformance Surgical Gowns, K210688 | ComparisonAnalysis |
|---|---|---|
| ANSI/AAMI PB70: 2012 Level 4 Liquid BarrierRequirements for Critical Zone - Pass | ANSI/AAMI PB70: 2012 Level 4Liquid Barrier Requirements forCritical Zone - Pass | Identical |
| ANSI/AAMI PB70: 2012 Level 1 Liquid BarrierRequirements for Non-Critical Zone- Pass | ANSI/AAMI PB70: 2012 Level 1Liquid Barrier Requirements for Non-Critical Zone - Pass | Identical |
| Biocompatibility per ISO 10993 – Pass thedevice under the conditions of the study is | Biocompatibility per ISO 10993 – Pass thedevice under the conditions of the | Identical |
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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* BreathablePerformance Surgical Gowns, K200522 | Subject Devices - AERO CHROME* SelectBreathable Performance Surgical Gownsand AERO CHROME* A-Line BreathablePerformance 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 ofMaterials (MOCON) - Pass | Identical |
| Linting per ISO 9073-10 - Pass | Linting per ISO 9073-10 - Pass | Identical |
| Standard Test Method for Breaking Strength andElongation of Textile Fabrics per ASTM D5034 -Pass | Standard Test Method for BreakingStrength and Elongation of TextileFabrics 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 SafetyCommission Part 1610 - Standard for theFlammability of Clothing Textiles Class 1 - Pass | 16 CFR, Chapter II - Consumer ProductSafety Commission Part 1610- Standard for the Flammability ofClothing Textiles Class 1 - Pass | Identical |
| Air Permeability (Back of Gown) per STM-00162, NWSP 070.1.RO - Pass | Air Permeability (Back of Gown) perSTM-00162 - Pass | Similar |
Summary of Non-Clinical Testing
| Standard/Reference | Test Method | Data Generated | MeetsRequirements |
|---|---|---|---|
| Liquid Barrier Performance | ANSI/AAMIPB70:2012 Level 4 | Resistance toPenetration byBlood-BornePathogens UsingPhi-X174Bacteriophage | Pass |
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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 PerformanceANSI/AAMI PB70:2012 Level 1 | Determine WaterResistance | Meets standardrequirements forLevel1 Liquid Barrier | Pass |
| Grab Tensile, Peak Stretch, and PeakEnergy - NonwovensASTM D5034 - 9 2017 | Determine TensileStrength | Meets standardrequirements forASTM D5034 -9 2017 | Pass |
| Abrasion Resistance ofNonwoven FabricsNWSP 020.5.RO (15) 2015 | Evaluate AbrasionResistance | Meets requirementsof standard NWSP020.5.RO (15) 2015 | Pass |
| Synthetic Blood PenetrationASTM F1670 (2017) | Resistance toPenetration | Meets standardrequirements forASTM F1670(2017) | Pass |
| Water Vapor Transmission RateNWSP 070.4.RO (15) 2015 | Water VaporTransmission | Meets standardrequirements forNWSP 070.4.RO (15)2015 | Pass |
| 180 Degree Peel Strength of Non-Elastic Laminated NonwovensSTM-00197 Rev 1 | Peel Strength | LSL:>125 grams | Pass |
| Linting ISO 9073-10 2003 | Particulate | Meets requirementfor ISO 9073-10 2003 | Pass |
| Standard for the Flammability forClothing Textiles16 CFR 1610 | Flammability | Meets Class 1requirements | Pass |
| ISO L929 MEM ElutionCytotoxicity ISO 10993-5:2009 | Cytotoxicity | < Grade 2 | Pass |
| ISO Indirect Primary Skin IrritationTest ISO 10993-10:2010 | Irritation | (mild reactivity) | Pass |
| ISO Kligman Maximization Test ISO10993-10:2010 | Sensitization | < 0.4 | Pass |
| EO Sterilization Residuals ISO 109937-7:2008 (R) 2012 | EO Residuals | Meet EO Residualrequirements perISO 1099370 -7:200(R) 12 | Pass |
| Laser Ignition Resistance ISO 11810-1:2015 | Evaluate LaserInduced Hazard | Class 1 ratingNo ignition | Pass |
Conclusion
The conclusion drawn from the nonclinical tests demonstrates that the subject devices in 510(k) submission K210688, the AERO CHROME* Select Breathable Performance Surgical Gown and AERO CHROME* A-Line Breathable Performance Surgical Gown, are as safe, as effective, and performs as well as or better than the legally marketed predicate device cleared under K200522.
§ 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.