(14 days)
The AERO CHROME* 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 microorganisms, body fluids, and particulate matter. The AERO CHROME* Breathable Performance Surgical Gowns meet the Level 4 AAMI PB70:2012 Liquid Barrier classifications.
The AERO CHROME* 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 has a Spundbond-Meltblown- Spunbond (SMS) fabric which allows for air-breathability with an AAMI Level 1 Liquid Barrier Performance Barrier. The AERO CHROME* 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: Small, Large, X-Large, XX-Large, XXX-Large, X-Long XL, X-Long XXL.
This document is a 510(k) Premarket Notification for the AERO CHROME* Breathable Performance Surgical Gowns, seeking substantial equivalence to a predicate device (K153255). It is not a study proving device meets acceptance criteria in the context of an AI/ML medical device. Therefore, it does not contain the information required to answer the requested questions regarding acceptance criteria, study design, sample sizes, expert involvement, or training data for an AI/ML device.
This document describes the physical and performance characteristics of a surgical gown and compares it to a previously cleared predicate device to demonstrate substantial equivalence for regulatory purposes. The "acceptance criteria" referred to in the document are the performance standards (e.g., AAMI PB70:2012 liquid barrier classifications, ISO standards for biocompatibility, flammability) that the surgical gown must meet. The "study" proving device meets acceptance criteria refers to the non-clinical testing performed on the gowns to ensure they comply with these standards.
Here's an attempt to answer the questions based on the provided document, understanding that the questions are framed for AI/ML devices and this document is for a physical medical device (surgical gown):
Acceptance Criteria and Device Performance (for a physical medical device - surgical gown)
The document primarily focuses on demonstrating that the subject device (AERO CHROME* Breathable Performance Surgical Gowns) is substantially equivalent to a predicate device (K153255) by meeting the same regulatory and performance standards. The "acceptance criteria" here are established industry standards and regulatory requirements for surgical gowns. The "reported device performance" is a statement of compliance with these standards based on non-clinical testing.
1. A table of acceptance criteria and the reported device performance
Based on the "Technological Characteristic Comparison Table" and "Summary of Non-Clinical Testing" sections:
| Acceptance Criteria (Standard/Test Method) | Reported Device Performance |
|---|---|
| Liquid Barrier Performance (Critical Zone) | |
| ANSI/AAMI PB70:2012 Level 4 Liquid Barrier Classification (Spray Impact - AATCC 42) | Pass (Water Resistance) |
| ANSI/AAMI PB70:2012 Level 4 Liquid Barrier Classification (Hydrostatic Pressure - AATCC 127) | Pass (Water Resistance) |
| Liquid Barrier Performance (Non-Critical Zone) | |
| ANSI/AAMI PB70:2012 Level 1 Liquid Barrier Classification (Spray Impact - AATCC 42) | Pass (Water Resistance) |
| Biocompatibility | |
| ISO 10993-5:2009 (MEM Elution Cytotoxicity) | Pass (Non-cytotoxic) |
| ISO 10993-10:2010 (Indirect Primary Skin Irritation Test) | Pass (Non-irritant) |
| ISO 10993-10:2010 (Kligman Maximization Test) | Pass (Non-sensitizing) |
| ISO 10993-7:2008 (R) 2012 (EO Sterilization Residuals) | Pass (Complies with EO Residuals) |
| Material Properties | |
| ASTM D5034-2017 (Grab Tensile, Peak Stretch, and Peak Energy - Nonwovens) | Pass (Tensile Strength) |
| NWSP 020.5.RO (15) 2015 (Abrasion Resistance of Nonwoven Fabrics) | Pass (Abrasion Resistance) |
| ASTM F1670 (2017) (Synthetic Blood Penetration) | Pass (Resistance to Penetration) |
| NWSP 070.4.RO (15) 2015 (Water Vapor Transmission Rate) | Pass (Water Vapor Transmission) |
| STM-00197 Rev 1 (180 Degree Peel Strength of Non-Elastic Laminated Nonwovens) | Pass (Peel Strength) |
| ISO 9073-10 2003 (Linting) | Pass (Particulate) |
| 16 CFR 1610 (Standard for the Flammability for Clothing Textiles) | Pass (Flammability - Class 1) |
| ISO 11810-1:2015 (Laser Ignition Resistance) | Pass (Laser Resistance) |
| STM-00162 (Air Permeability - Back of Gown) | Pass (Air Permeability) |
2. Sample sized used for the test set and the data provenance
The document does not specify the exact sample sizes used for each material or performance test. It states "non-clinical tests" were conducted. The data provenance is industrial testing of material and product performance, typically conducted in a laboratory setting by the manufacturer or a third-party testing facility. This is a prospective testing regimen to ensure product quality and regulatory compliance. Country of origin for data is not specified but would be the location of the testing laboratories.
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 to this type of device. "Ground truth" in this context is established by standardized test methods (e.g., AATCC, ASTM, ISO standards) and the results obtained from calibrated scientific instruments. There are no human "experts" establishing ground truth in the sense of medical diagnosis or image annotation for this product testing. The "experts" involved would be qualified laboratory technicians and engineers proficient in performing the specified material and performance tests.
4. Adjudication method for the test set
Not applicable. This is not an AI/ML or diagnostic study requiring adjudication of expert opinions. Results are binary (Pass/Fail) based on meeting pre-defined thresholds in the specified standards.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done
Not applicable. This is a physical medical device (surgical gown), not a diagnostic tool or AI/ML system, so MRMC studies are not relevant. This document is a comparison of the subject device to a predicate device based on material composition and physical performance, not a comparative effectiveness study involving human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an algorithm. The "standalone" performance here refers to the gown's intrinsic physical and barrier properties as measured in the laboratory tests.
7. The type of ground truth used
The "ground truth" for this device is based on standardized physical and chemical test results against established performance specifications (e.g., AAMI PB70, ISO 10993, ASTM standards). It is not expert consensus, pathology, or outcomes data in the medical context of AI/ML.
8. The sample size for the training set
Not applicable. Surgical gowns are not "trained" like AI models. The document describes the "construction overview" and materials used, which are the product's design specifications. There isn't a "training set" in the computational sense.
9. How the ground truth for the training set was established
Not applicable. As there is no "training set," there is no "ground truth" to establish for it in this context. The manufacturing process and material specifications for the gown are derived from engineering design, material science data, and compliance with the relevant industry standards.
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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 a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
March 16, 2020
O&M Halyard, Inc Kimberly Lewis Sr. Manager, Regulatory Affairs 9120 Lockwood Blvd Mechanicsville, Virginia 23116
Re: K200522
Trade/Device Name: AERO CHROME* Breathable Performance Surgical Gowns Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical Apparel Regulatory Class: Class II Product Code: FY A Dated: February 28, 2020 Received: March 2, 2020
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 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,
Elizabeth F. Claverie, MS 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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known)
Device Name
AERO CHROME* Breathable Performance Surgical Gowns
Indications for Use (Describe)
The AERO CHROME* 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 microorganisms, body fluids, and particulate matter. The AERO CHROME* Breathable Performance Surgical Gowns meet the Level 4 AAMI PB70:2012 Liquid Barrier classifications.
| Non-Sterile Product Codes | ||
|---|---|---|
| Product Code | Device 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 | X-Large |
| 44665NS | AERO CHROME* Breathable Performance Surgical Gown, XL - Handi-Bin | X-Large |
| 44666NS | AERO CHROME* Breathable Performance Surgical Gown, XXL | XX-Large |
| 44667NS | AERO CHROME* Breathable Performance Surgical Gown, L, X-Long | Large, X-Long |
| 44668NS | AERO CHROME* Breathable Performance Surgical Gown, XL, X-Long | X-Large, X-Long |
| 44669NS | AERO CHROME* Breathable Performance Surgical Gown, XXL, X-Long | XX-Large, X-Long |
| 44670NS | AERO CHROME* Breathable Performance Surgical Gown with Towel in Overwrap, L - Handi-Bin | Large |
| 44671NS | AERO CHROME* Breathable Performance Surgical Gown with Towel in Overwrap, XL - Handi-Bin | X-Large |
| Sterile Product Codes | ||
| Product Code | Device Description | Gown Size |
| 44672 | AERO CHROME* Breathable Performance Surgical Gown with Towel, S | Small |
| 44673 | AERO CHROME* Breathable Performance Surgical Gown with Towel, L | Large |
| 44674 | AERO CHROME* Breathable Performance Surgical Gown with Towel, XL | X-Large |
| 44675 | AERO CHROME* Breathable Performance Surgical Gown with Towel, XXL | XX-Large |
| 44676 | AERO CHROME* Breathable Performance Surgical Gown with Towel, XXXL | XXX-Large |
| 44677 | AERO CHROME* Breathable Performance Surgical Gown with Towel, L, X-Long | Large, X-Long |
| 44678 | AERO CHROME* Breathable Performance Surgical Gown with Towel, XL, X-Long | X-Large, X-Long |
| 44679 | AERO CHROME* Breathable Performance Surgical Gown with Towel, XXL, X-Long | XX-Large, X-Long |
XX-Large, X-Long
Type of Use (Select one or both, as applicable)
X-Long
_ Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
Form Approved: OMB No. 0910-0120
Expiration Date: 06/30/2020
See PRA Statement below.
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Image /page/4/Picture/0 description: The image shows two company logos side by side. On the left is the Owens & Minor logo, featuring the letters "OM" in a bold, maroon color with horizontal lines running through them, followed by the words "Owens & Minor" in a smaller, gray font. To the right is the Halyard logo, which includes a stylized green and white mountain peak inside a dark blue circle, followed by the word "HALYARD" in a bold, dark blue font.
510(k) Summary
| 510(k) Number: | K200522 |
|---|---|
| Date Prepared: | February 28, 2020 |
| 510(k) Sponsor: | O&M Halyard Inc.9120 Lockwood BoulevardMechanicsville, VA 23116 |
| Regulatory Contact: | Kimberly Lewis5405 Windward Pkwy3rd Floor WestAlpharetta, GA 30004470-280-4388Kimberly.lewis@hyh.com |
| Device Trade Name: | AERO CHROME* Breathable Performance Surgical Gowns |
| Device Common Name: | Surgical Gown |
| FDA Device Product Code: | FYA |
| FDA Device Classification: | Class II |
| FDA Device Name: | Gown, Surgical |
| FDA Regulation Number: | 21 CFR 878.4040 |
| Predicate Device: | K153255 – AERO CHROME* Breathable Performance SurgicalGowns |
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Image /page/5/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 horizontal lines running through them, followed by the words "Owens & Minor" in a smaller, gray font. On the right is the Halyard logo, which consists of a green and white upward-pointing arrow inside a blue circle, followed by the word "HALYARD" in a bold, blue font.
Device
| Description: | The AERO CHROME* 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 has a Spundbond-Meltblown- Spunbond (SMS) fabric which allows for air-breathability with an AAMI Level 1 Liquid Barrier Performance Barrier. |
|---|---|
| -------------- | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |
The AERO CHROME* 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: Small, Large, X-Large, XX-Large, XXX-Large, X-Long XL, X-Long XXL.
Indications for
Use: 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 AAMI PB70:2012 Liquid Barrier classifications.
Product Codes Subject to this Premarket Notification
| Product Code | Device Description |
|---|---|
| 44661NS | AERO CHROME* Breathable Performance Surgical Gown, S (Non-Sterile) |
| 44662NS | AERO CHROME* Breathable Performance Surgical Gown, L (Non-Sterile) |
| 44663NS | AERO CHROME* Breathable Performance Surgical Gown, L - Handi-Bin (Non-Sterile) |
| 44664NS | AERO CHROME* Breathable Performance Surgical Gown, XL (Non-Sterile) |
| 44665NS | AERO CHROME* Breathable Performance Surgical Gown, XL - Handi-Bin (Non-Sterile) |
| 44666NS | AERO CHROME* Breathable Performance Surgical Gown, XXL (Non-Sterile) |
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Image /page/6/Picture/0 description: The image shows two company logos side by side. On the left is the Owens & Minor logo, featuring the letters "OM" in a bold, maroon color with horizontal lines running through them, followed by the words "Owens & Minor" in a smaller, gray font. To the right is the Halyard logo, which includes a stylized green and white icon resembling a sail or a stylized "H", accompanied by the word "HALYARD" in a bold, dark blue font.
| 44667NS | AERO CHROME* Breathable Performance Surgical Gown, L, X-Long (Non-Sterile) |
|---|---|
| 44668NS | AERO CHROME* Breathable Performance Surgical Gown, XL, X-Long (Non-Sterile) |
| 44669NS | AERO CHROME* Breathable Performance Surgical Gown, XXL, X-Long (Non-Sterile) |
| 44670NS | AERO CHROME* Breathable Performance Surgical Gown with Towel in Overwrap, L - Handi-Bin (Non-Sterile) |
| 44671NS | AERO CHROME* Breathable Performance Surgical Gown with Towel in Overwrap, XL - Handi-Bin (Non-Sterile) |
| 44672 | AERO CHROME* Breathable Performance Surgical Gown with Towel, S |
| 44673 | AERO CHROME* Breathable Performance Surgical Gown with Towel, L |
| 44674 | AERO CHROME* Breathable Performance Surgical Gown with Towel, XL |
| 44675 | AERO CHROME* Breathable Performance Surgical Gown with Towel, XXL |
| 44676 | AERO CHROME* Breathable Performance Surgical Gown with Towel, XXXL |
| 44677 | AERO CHROME* Breathable Performance Surgical Gown with Towel, L, X-Long |
| 44678 | AERO CHROME* Breathable Performance Surgical Gown with Towel, XL, X-Long |
| 44679 | AERO CHROME* Breathable Performance Surgical Gown with Towel, XXL, X-Long |
Technological Characteristic Comparison Table
| Attribute | Predicate Device (AEROCHROME* BreathablePerformance SurgicalGown, K153255) | Subject Device | ComparisonAnalysis |
|---|---|---|---|
| FDAClassificationCode | FYA | FYA | Identical |
| FDA DeviceClassification | Class II | Class II | Identical |
| Attribute | Predicate Device (AEROCHROME* BreathablePerformance SurgicalGown, K153255) | Subject Device | ComparisonAnalysis |
| CommonDevice Name | Surgical Gown | Surgical Gown | Identical |
| Trade Name | AERO CHROME*Breathable PerformanceSurgical Gown | AERO CHROME*Breathable PerformanceSurgical Gown | Identical |
| Indications forUse | AERO CHROME*Breathable PerformanceSurgical Gowns aresterile, single use surgicalapparel intended to beworn by healthcareprofessionals to helpprotect both the patientand the healthcare workerfrom the transfer ofmicroorganisms, bodyfluids, and particulatematter.The AERO CHROME*Breathable PerformanceSurgical Gowns meet theLevel 4 AAMI PB70Liquid Barrierclassifications | AERO CHROME*Breathable PerformanceSurgical Gowns aresterile, single use surgicalapparel intended to beworn by healthcareprofessionals to helpprotect both the patientand the healthcare workerfrom the transfer ofmicroorganisms, bodyfluids, and particulatematter.The AERO CHROME*Breathable PerformanceSurgical Gowns meet theLevel 4 AAMI PB70Liquid Barrierclassifications. | Identical |
| 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,X-Long XL, X-Long XXL | Small, Large, X-Large,XX-Large, XXX-Large,X-Long XL, X-Long XXL | Identical |
| ConstructionOverview | The AERO CHROME*Breathable PerformanceSurgical Gown ismanufactured from amoisture-vaporbreathable, repellent, non- | The AERO CHROME*Breathable PerformanceSurgical Gown ismanufactured from amoisture-vaporbreathable, non-woven | Similar |
| Attribute | Predicate Device (AEROCHROME* BreathablePerformance SurgicalGown, K153255) | Subject Device | ComparisonAnalysis |
| polymer blend ofpolypropylene andpolyethylene. The frontbody and sleeve fabric area three- layer filmlaminate. This fabric is anS/F/SMS design that isadhesively bondedtogether. The film itself isa multi-layerpolypropylene-basedvapor breathablemembrane that usesCaCO3 filler to createmicropores to allow vaportransmission across themembrane. Thepolyolefin hot meltadhesive is used tolaminate the facing layersto the film layer tocomplete the composite.Sleeves of the gown areclosed with a heat-sealingprocess to meet AAMI-4liquid barrierrequirements. The backof the AERO CHROME*Breathable PerformanceSurgical Gown in the non-critical zone is composedof 1.2 osy SMS fabricwith an AAMI level 1liquid barrier protection.The gown film layer istreated with afluorochemical. | blend 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,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-sealingprocess to meet AAMI-4liquid barrierrequirements. The backof the AERO CHROME*Breathable PerformanceSurgical Gown in the non-critical zone is composedof 1.2 osy SMS fabricwith an AAMI level 1liquid barrier protection. | ||
| Does notcontain naturalrubber latex | Yes | Yes | Identical |
| Predicate Device (AEROCHROME* BreathablePerformance Surgical Gowns,K153255) | Subject Device | ComparisonAnalysis | |
| ANSI/AAMI PB70: 2012 Level 4Liquid Barrier Requirements forCritical Zone - Pass | ANSI/AAMI PB70: 2012 Level 4Liquid 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 the conditionsof 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 the Flammabilityof Clothing Textiles Class 1 - Pass | 16 CFR, Chapter II – ConsumerProduct Safety Commission Part1610 – Standard for theFlammability of Clothing TextilesClass 1 Pass | Identical | |
| Air Permeability (Back of Gown) perSTM-00162. NWSP 070.1.RO - Pass | Air Permeability (Back of Gown)per STM-00162 - Pass | Similar | |
| Standard/Reference | Test Method | Data Generated | MeetsRequirements |
| Spray Impact (CriticalZones) | AATCC 42 | Water Resistance | Pass |
| Hydrostatic Pressure(Critical Zones) | AATCC 127 | Water Resistance | Pass |
| Liquid Barrier Performance | ANSI/AAMIPB70:2012 Level 4 | 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 109937-7:2008 (R) 2012 | EO Residuals | Pass |
| Laser Ignition Resistance | ISO 11810-1:2015 | Laser Resistance | Pass |
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Image /page/7/Picture/0 description: The image contains two company logos. The first logo is for Owens & Minor, featuring a maroon-colored emblem with horizontal lines and the company name in gray text. The second logo is for Halyard, consisting of a blue circle with a white and green abstract shape inside, followed by the company name in bold blue letters. The logos are placed side by side.
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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 font 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 circular emblem with a green triangle inside, accompanied by the word "HALYARD" in a bold, dark blue font.
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Image /page/9/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 a stylized red "OM" and the company name in gray. The Halyard logo is on the right and features a green and blue stylized shape next to the company name in blue.
Performance Testing
Testing conducted to support the changes of the subject device shows that the AERO CHROME* Breathable Performance Surgical Gown is similar to the predicate device AERO CHROME* Breathable Performance Surgical Gown (K153255) in design, intended use, sterility, and technological characteristics. In the critical zone, the AERO CHROME* Breathable Performance Surgical Gowns meet the Level 4 AAMI
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Image /page/10/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 stylized font, with the words "Owens & Minor" to the right. The Halyard logo is on the right and consists of a green and blue symbol, with the word "HALYARD" in blue to the right.
PB70:2012 Liquid Barrier classification. The back of the gown meets the Level 1 AAMI PB70:2012 Liquid Barrier classification.
Summary of Non-Clinical Testing
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Image /page/11/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 "OM" in maroon and the company name in gray. The Halyard logo is on the right, with a blue circle containing a white and green shape, followed by the company name in blue. The logos are separated by a vertical gray line.
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.