(155 days)
The Aero Chrome* Breathable Performance Surgical Gowns are sterile, single use surgical apparel intended to be worn by healthcare professionals to help protect both the patient and the healthcare worker from the transfer of microorganisms, body fluids, and particulate matter. The Aero Chrome* Breathable Performance Surgical Gowns meet the Level 4 requirements of the AAMI PB70:2012 Liquid Barrier classifications.
The Aero Chrome* Breathable Performance Surgical Gowns are also sold as bulk non-sterile, single use items, to repackager/relabeler establishments for further packaging and Ethylene Oxide (EtO) sterilization
The Aero Chrome* Breathable Performance Surgical Gowns have a Spunbond/Film/Spunbond/Meltblown/Spunbond design (SFSMS) that provides AAMI Level 4 liquid barrier protection in the critical zones of the gown. The back of the Aero Chrome* Breathable Performance Surgical Gown in the non-critical zone has a SMS Spunbond/meltblown/spunbond) fabric that is air-breathable and provides AAMI Level 1 liquid barrier protection. The Aero Chrome* Breathable Performance Surgical Gowns are single use, disposable medical device that will be provided in a variety of sterile and non-sterile packaging configurations described below.
The provided document is a 510(k) premarket notification for a medical device: the Aero Chrome Breathable Performance Surgical Gown*. This type of submission focuses on demonstrating substantial equivalence to an already legally marketed predicate device, rather than proving novel efficacy or safety through primary clinical trials for the device itself. Therefore, the "study" proving the device meets acceptance criteria primarily consists of non-clinical performance testing to show that the new device performs at least as well as, or equivalently to, the predicate device in relevant aspects.
Here's an analysis of the acceptance criteria and the provided information:
1. A table of acceptance criteria and the reported device performance:
The document doesn't present a single consolidated "acceptance criteria" table as one might find for a diagnostic AI device with precision/recall metrics. Instead, it details various performance tests demonstrating compliance with recognized standards for surgical gowns. The acceptance criteria for each test are implicitly (or explicitly, as "Pass") stated as meeting the requirements of the specified standard.
| Acceptance Criteria (Standard & Level) | Test Method | Reported Device Performance (Aero Chrome*) |
|---|---|---|
| AAMI PB70:2012 Liquid Barrier Classifications | Resistance to Penetration by Blood-Borne Pathogens Using Phi-X174 Bacteriophage (Level 4) | Pass |
| Water resistance (Level 1 in non-critical zones) | Pass | |
| 16 CFR 1610 (Flammability) | Flammability | Pass (Class I) |
| ISO 10993-5:2009 (Biological Evaluation) | Cytotoxicity | Pass (non-cytotoxic) |
| ISO 10993-10:2010 (Biological Evaluation) | Skin Irritation Study | Pass (negligible irritant) |
| Sensitization Test | Pass (non-sensitizing) | |
| ISO 10993-7:2008 (EO Sterilization) | EO residuals | Pass |
| ISO 11810-1 (2005) (Laser Ignition Resistance) | Laser resistance | Pass |
| AATCC 42:2013 (Spray Impact) | Water resistance | Pass |
| ASTM D5034 (2009) (Grab Tensile) | Tensile Strength | Pass |
| WSP 20.5 (2008) (Abrasion Resistance) | Abrasion resistance | Pass |
| ASTM-1670-08 (2008) (Synthetic Blood Penetration) | Resistance to penetration | Pass |
| D3776 (2009) (Mass Per Area) | Fabric basis weight | Pass |
| WSP 70.4 (2008) (Water Vapor Transmission Rate) | Water Vapor Transmission | Pass |
| STM-00197 (2010) (Peel Strength) | Peel Strength | Pass |
| INDA WSP 160.1 (2009) (Linting) | Particulate | Pass |
2. Sample size used for the test set and the data provenance:
- Sample Size: The document does not specify the exact sample sizes used for each individual non-clinical performance test. Standard test methods (e.g., ASTM, ISO, AAMI) typically define the minimum sample sizes required for statistically valid testing. For example, for textile testing (tensile strength, abrasion), there would be a specified number of specimens. For biocompatibility (cytotoxicity, irritation, sensitization), there would be a defined number of replicates and control groups.
- Data Provenance: The data comes from the manufacturer's (Halyard Health, Inc.) own non-clinical performance testing. It is not explicitly stated if these were internal labs or third-party labs, but generally, such tests are conducted in controlled lab environments. The document does not specify a country of origin for the data; it's implicit to be associated with Halyard Health's operations for regulatory submission in the US.
- Retrospective or Prospective: These are prospective tests performed specifically to demonstrate that the newly designed Aero Chrome* gown meets the required performance standards for its intended use and for comparison with the predicate device.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This question is not applicable in the context of this device and submission. This is a surgical gown, not an AI/diagnostic device that relies on expert interpretation of images or patient data to establish ground truth. The "ground truth" for a surgical gown's performance is established by objective, measurable physical, chemical, and biological properties, as defined by recognized consensus standards (e.g., AAMI, ISO, ASTM). The expertise lies in conducting the tests according to the standard protocols and interpreting the quantitative results against the specified pass/fail criteria.
4. Adjudication method for the test set:
- This question is not applicable. Since the "ground truth" is established through objective laboratory testing against predefined standards (e.g., a specific resistance value, a pass/fail for bacterial penetration), there is no human "adjudication" in the sense of multiple readers or experts reviewing subjective data. The test results are quantitative/qualitative outcomes of physical/chemical processes.
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:
- This question is not applicable. This is a physical medical device (surgical gown), not an AI diagnostic algorithm. Therefore, MRMC studies and AI assistance are irrelevant to its evaluation.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- This question is not applicable. This is a physical medical device, not an algorithm.
7. The type of ground truth used:
- The ground truth for this device's performance is established by objective, quantitative measurements and qualitative assessments derived from standardized laboratory test methods (e.g., AAMI PB70:2012, ASTM D5034, ISO 10993 series). These standards define specific criteria (e.g., pressure resistance, microbial penetration, tensile strength limits, cytotoxicity levels) that the device must meet. It is not based on expert consensus, pathology, or outcomes data in the way a diagnostic tool would be.
8. The sample size for the training set:
- This question is not applicable. This is a physical device, and there is no "training set" in the context of machine learning. The manufacturing process of surgical gowns involves material selection, design, and fabrication, which are validated through process controls and quality assurance, not through a "training set" of data.
9. How the ground truth for the training set was established:
- This question is not applicable for the reasons stated above.
In summary: The submission for the Aero Chrome* Breathable Performance Surgical Gown focuses on demonstrating substantial equivalence to a predicate device (Aero Blue* Performance Surgical Gown) by providing comprehensive non-clinical performance test results against established industry standards. The "acceptance criteria" are the "Pass" outcomes for each of these standardized tests, indicating that the gown meets the specified physical, chemical, and biological performance requirements relevant to its intended use as protective apparel. The evaluation does not involve clinical studies with human "readers" or AI algorithms.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
April 13, 2016
Halyard Health, Inc. David Lee Associate Director, Regulatory Affairs 5405 Windward Parkway Alpharetta, Georgia 30004
Re: K153255
Trade/Device Name: Aero Chrome* Breathable Performance Surgical Gown Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical Apparel Regulatory Class: II Product Code: FYA Dated: March 7, 2016 Received: March 8, 2016
Dear David Lee:
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. 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 requirements, including, but not limited to: registration and listing (21 CFR
{1}------------------------------------------------
Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours.
Tejashri Purohit-Sheth, M.D.
Tejashri Purohit-Sheth, M.D. Clinical Deputy Director DAGRID/ODE/CDRH FOR
Erin I. Keith, M.S. Division Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.
510(k) Number (if known) K153255
Device Name Aero Chrome* Breathable Performance Surgical Gown
Indications for Use (Describe)
The Aero Chrome* Breathable Performance Surgical Gowns are sterile, single use surgical apparel intended to be worn by healthcare professionals to help protect both the patient and the healthcare worker from the transfer of microorganisms, body fluids, and particulate matter. The Aero Chrome* Breathable Performance Surgical Gowns meet the Level 4 requirements of the AAMI PB70:2012 Liquid Barrier classifications.
The Aero Chrome* Breathable Performance Surgical Gowns are also sold as bulk nonsterile, single use items, to repackager/relabeler establishments for further packaging and Ethylene Oxide (EtO) sterilization
| 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) |
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This submission addresses the Aero Chrome* Breathable Performance Surgical Gown models described below.
STERILE CODES
| PRODUCTSTOCK CODE | DESCRIPTION | GOWN SIZE |
|---|---|---|
| 44672 | Aero Chrome* Breathable PerformanceSurgical Gown, S | Small |
| 44673 | Aero Chrome* Breathable PerformanceSurgical Gown, L | Large |
| 44674 | Aero Chrome* Breathable PerformanceSurgical Gown, XL | Xlarge |
| 44675 | Aero Chrome* Breathable PerformanceSurgical Gown, XXL | XXLarge |
| 44676 | Aero Chrome* Breathable PerformanceSurgical Gown, XXXL | XXXLarge |
| 44677 | Aero Chrome* Breathable PerformanceSurgical Gown, L, X-Long | Large Xlong |
| 44678 | Aero Chrome* Breathable PerformanceSurgical Gown, XL, X-Long | XLarge Xlong |
| 44679 | Aero Chrome* Breathable PerformanceSurgical Gown, XXL, X-Long | XXLarge Xlong |
NON-STERILE CODES
| PRODUCT | DESCRIPTION | GOWN SIZE |
|---|---|---|
| STOCK CODE | ||
| 44661NS | Aero Chrome* Breathable PerformanceSurgical Gown, S | Small |
| 44662NS | Aero Chrome* Breathable PerformanceSurgical Gown, L | Large |
| 44663NS | Aero Chrome* Breathable PerformanceSurgical Gown, L - Handi-Bin | Large |
| 44664NS | Aero Chrome* Breathable PerformanceSurgical Gown, XL | Xlarge |
| 44665NS | Aero Chrome* Breathable PerformanceSurgical Gown, XL - Handi-Bin | Xlarge |
| 44666NS | Aero Chrome* Breathable PerformanceSurgical Gown, XXL | XXLarge |
| 44667NS | Aero Chrome* Breathable PerformanceSurgical Gown, L, X-Long | Large Xlong |
| 44668NS | Aero Chrome* Breathable PerformanceSurgical Gown, XL, X-Long | XLarge Xlong |
| 44669NS | Aero Chrome* Breathable PerformanceSurgical Gown, XXL, X-Long | XXLarge Xlong |
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510(k) Summary
| Date Summarywas Prepared: | April 13, 2016 |
|---|---|
| 510(k)Submitter: | David M. Lee, JDAssociate Director of Regulatory Affairs,HALYARD HEALTH5405 Windward ParkwayAlpharetta, GA 30004470 448 5182David.lee@hyh.com |
| Primary Contactfor this 510(k)Submission: | David M. Lee, JDAssociate Director of Regulatory Affairs,HALYARD HEALTH5405 Windward ParkwayAlpharetta, GA 30004470 448 5182David.lee@hyh.com |
| Device TradeName: | Aero Chrome* Breathable Performance Surgical Gown(hereinafter described as "Aero Chrome*") |
| Device CommonNames | Surgical Gown |
| Device ProductCodes,ClassificationName andRegulation: | FYAClass II878.4040 Surgical Apparel |
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Predicate Device
The Aero Chrome* Breathable Performance Surgical Gown under submission is substantially equivalent to the predicate device, the Aero Blue* Performance Surgical Gown (K140539).
Device The Aero Chrome* Breathable Performance Surgical Gowns Description: have a Spunbond/Film/Spunbond/Meltblown/Spunbond design (SFSMS) that provides AAMI Level 4 liquid barrier protection in the critical zones of the gown. The back of the Aero Chrome* Breathable Performance Surgical Gown in the non-critical zone has a SMS Spunbond/meltblown/spunbond) fabric that is air-breathable and provides AAMI Level 1 liquid barrier protection. The Aero Chrome* Breathable Performance Surgical Gowns are single use, disposable medical device that will be provided in a variety of sterile and non-sterile packaging configurations described below.
The Aero Chrome* Breathable Performance Surgical Gowns are Intended Use: 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 Chrome* Breathable Performance Surgical Gowns meet the Level 4 requirements of the AAMI PB70:2012 Liquid Barrier classifications.
The Aero Chrome* Breathable Performance Surgical Gowns are also sold as bulk non-sterile, single use items, to repackager/relabeler establishments for further packaging and Ethylene Oxide (EtO) sterilization
This submission covers the Aero Chrome* Breathable Performance Surgical Gowns models described below.
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Product Code and Description
STERILE CODES
| PRODUCT STOCKCODE | DESCRIPTION | GOWN SIZE |
|---|---|---|
| 44672 | Aero Chrome* Breathable PerformanceSurgical Gown, S | Small |
| 44673 | Aero Chrome* Breathable PerformanceSurgical Gown, L | Large |
| 44674 | Aero Chrome* Breathable PerformanceSurgical Gown, XL | Xlarge |
| 44675 | Aero Chrome* Breathable PerformanceSurgical Gown, XXL | XXLarge |
| 44676 | Aero Chrome* Breathable PerformanceSurgical Gown, XXXL | XXXLarge |
| 44677 | Aero Chrome* Breathable PerformanceSurgical Gown, L, X-Long | Large Xlong |
| 44678 | Aero Chrome* Breathable PerformanceSurgical Gown, XL, X-Long | XLarge Xlong |
| 44679 | Aero Chrome* Breathable PerformanceSurgical Gown, XXL, X-Long | XXLarge Xlong |
NON-STERILE CODES
| PRODUCT STOCKCODE | DESCRIPTION | GOWN SIZE |
|---|---|---|
| 44661NS | Aero Chrome* Breathable Performance Surgical Gown, S | Small |
| 44662NS | Aero Chrome* Breathable Performance Surgical Gown, L | Large |
| 44663NS | Aero Chrome* Breathable Performance Surgical Gown, L - Handi-Bin | Large |
| 44664NS | Aero Chrome* Breathable Performance Surgical Gown, XL | Xlarge |
| 44665NS | Aero Chrome* Breathable Performance Surgical Gown, XL - Handi-Bin | Xlarge |
| 44666NS | Aero Chrome* Breathable Performance Surgical Gown, XXL | XXLarge |
| 44667NS | Aero Chrome* Breathable Performance Surgical Gown, L, X-Long | Large Xlong |
| 44668NS | Aero Chrome* Breathable Performance Surgical Gown, XL, X-Long | XLarge Xlong |
| 44669NS | Aero Chrome* Breathable Performance Surgical Gown, XXL, X-Long | XXLarge Xlong |
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Summary of Non-Clinical Testing
| Standard or Reference | Test Method | Data Generated | MeetsRequirement |
|---|---|---|---|
| Standard for the Flammability for Clothing Textiles | 16 CFR 1610 | Flammability | Pass |
| ISO 10993-5:2009 Biological Evaluation of MedicalDevices-Part 5: | Cytotoxicity | Cytotoxicity | Pass, under theconditions of thestudy non-cytotoxic |
| ISO 10993-10:2010 Biological Evaluation of MedicalDevices-Part 10 | Skin Irritation Study | Irritation | Pass, under theconditions of thestudy anegligible irritant |
| ISO 10993-10:2010 Biological Evaluation of MedicalDevices-Part 10 | Sensitization Test | Sensitization | Pass, under theconditions of thestudy non-sensitizing |
| ISO 10993-7:2008, Ethylene Oxide sterilizationresiduals | EO residuals | EO residuals | Pass |
| Laser Ignition Resistance | ISO 11810-1 (2005) | Laser resistance | Pass |
| AAMI Liquid Barrier Performance in Critical Zone(body, sleeves, and ties) | AAMI PB70:2012Level 4 | Resistance toPenetration byBlood-BornePathogens UsingPhi-X174Bacteriophage | Pass |
| AAMI Liquid Barrier Performance Level 1 in non-criticalside seams, raglan sleeve to shoulder seams, andSMS area in back of gown | AAMI PB70:2012Level 1 | Water resistance | Pass |
| Spray Impact(1.2 osy SMS in non-critical zone on back) | AATCC 42:2013 | Water resistance | Pass |
| Grab Tensile, Peak Stretch, and Peak Energy -Nonwovens | ASTM D5034(2009) | Tensile Strength | Pass |
| Abrasion Resistance and Surface Bonding of SMSLaminates | WSP 20.5 (2008) | Abrasion resistance | Pass |
| Synthetic Blood Penetration(fabric only in critical zone) | ASTM-1670-08(2008) | Resistance topenetration | Pass |
| Mass Per Area (Basis Weight) of Materials | D3776 (2009) | Fabric basis weight | Pass |
| Water Vapor Transmission Rate Through Nonwovensand Plastic Films | WSP70.4 (2008) | Water VaporTransmission | Pass |
| Degree Peel Strength of Laminated Nonwovens - RawMaterials | STM-00197(2010) | Peel Strength | Pass |
| Resistance to Linting Dry Particle Generation | INDA WSP 160.1(2009) | Particulate | Pass |
Test results establish that the product met the predetermined specifications.
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Substantial Equivalence Table
| Attribute | Device Under Submission:Aero Chrome* BreathablePerformance Surgical Gown | Predicate Device of this 510(k):K140539 Aero Blue*Performance Surgical Gown |
|---|---|---|
| Indicationsfor Use | The Aero Chrome* BreathablePerformance Surgical Gowns aresterile, single use surgical apparelintended to be worn by healthcareprofessionals to help protect both thepatient and the healthcare worker fromthe transfer of microorganisms, bodyfluids, and particulate matter. The AeroChrome* Breathable PerformanceSurgical Gowns meet the Level 4requirements of the AAMI PB70:2012Liquid Barrier classifications.The Aero Chrome* BreathablePerformance Surgical Gowns are alsosold as bulk non-sterile, single useitems, to repackager/relabelerestablishments for further packagingand Ethylene Oxide (EtO) sterilization | Aero Blue* Performance SurgicalGowns, are sterile, single use surgicalapparel intended to be worn byhealthcare professionals to help protectboth the patient and the healthcareworker from the transfer ofmicroorganisms, body fluids, andparticulate matter.The Aero Blue* PerformanceSurgical Gowns meet the Level 3requirements of the AAMI PB70: 2012Liquid Barrier classifications.The Aero Blue* Performance SurgicalGowns, are also sold as bulk non-sterile, single use items, torepackager/relabeler establishments forfurther packaging and Ethylene Oxide(EtO) sterilization. |
| Howsupplied | Sterile ( $10^{-6}$ ) or bulk non-sterile | Same |
| SterilizationMethod | Ethylene Oxide | Same |
| SAL | $10^{-6}$ | Same |
| Gown color | Gray | Blue |
| Gown sizes | Small, Large, X-Large, XX-Large,XXX-Large, L X-Long, XXL X- Long | Small, Large, X-Large, XX-Large,XXX-Large |
| ConstructionOverview | The Aero Chrome* BreathablePerformance Surgical Gowns undersubmission are manufactured from amoisture-vapor breathable, repellent,non-woven fabric using a polymerblend of polypropylene andpolyethylene. The front body andsleeve fabric is a three layer filmlaminate. This fabric is an SFSMSdesign Spunbond/Film/Spunbond-Meltblown-Spunbond that is adhesivelybonded together. The Aero Chrome*Breathable Performance SurgicalGowns in the critical zone meet AAMI-4 liquid barrier requirements, whileback of gown in the non-critical zone iscomposed of a breathable SMS fabricwith an AAMI level 1 liquid barrierprotection. | The Aero Blue Performance SurgicalGown is manufactured from amoisture-vapor breathable, repellent,non-woven fabric using a polymerblend of polypropylene andpolyethylene. The front body andsleeve fabric is a three layer filmlaminate. This fabric is an SFSMSdesign Spunbond/Film/Spunbond-Meltblown-Spunbondthat is adhesively bonded together.Front of Gown meets meet AAMI-3liquid barrier requirements, while backof Gown in the non-critical zone iscomposed of a breathable SMS fabricwith an AAMI level 1 liquid barrierprotection. |
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| Notmadewithnaturalrubberlatex | Yes | Same |
|---|---|---|
| --------------------------------------------------- | ----- | ------ |
Performance Testing
| Attribute | Device Under Submission:Aero Chrome* Breathable PerformanceSurgical Gowns | Predicate Device of this510(k):K140539 Aero Blue*Performance Surgical Gown, |
|---|---|---|
| PerformanceTesting inCritical Zone | ANSI/AAMI PB70: 2012 Level 4 Liquid BarrierRequirements - Pass | ANSI/AAMI PB70: 2012 Level3 |
| W SP 70.4 (STM-00164)-W ater VaporTransmission Rate - Pass | Same | |
| W SP 160.1 (STM-00353) Test Method forResistance to Linting: Dry Particle Generationwith a Modified Gelbo Flex Unit -Pass | Same | |
| ASTM D 5034 - 2009 Standard Test Method ForBreaking Strength and Elongation of TextileFabrics (Grab Test) - Pass | Same | |
| ASTM F1670:2008 for fabric in critical zone-Pass | Same | |
| STM- 00149 (W SP 20.5 2008), AbrasionResistance Test - Pass | Same | |
| Biocompatibility per ISO 10993 – Pass, thedevice under the conditions of the study is non-cytotoxic, non-irritant, and non-sensitizing. | Same, device under theconditions of the study was non-cytotoxic, non-irritant, and non-sensitizing. | |
| 16 CFR, Chapter II--Consumer Product SafetyCommission Part 1610 -Standard For TheFlammability of Clothing Textiles Class I - Pass | Same | |
| Laser Ignition Resistance/ ISO 11810- Pass | Same |
Conclusion The performance testing submitted for the Aero Chrome* Breathable Performance Surgical Gown demonstrates substantial equivalence to the predicate Aero Blue* Performance Surgical Gown (K140539) in intended use, design, materials, performance, and biocompatibility attributes.
*Registered Trademark or Trademark of Halyard Health, Inc. or its affiliates.
§ 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.