(97 days)
The Aero Blue* Performance Surgical Gowns are sterile, single use surgical apparel intended to be worn by healthcare professionals to help protect both the patient and the healthcare worker from the transfer of microorganisms, body fluids, and particulate matter. The Aero Blue* Performance Surgical Gowns meet the Level 3 requirements of the AAMI PB70: 2012 Liquid Barrier classifications. The Aero Blue* 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.
A Spunbond/Film/Spunbond/Meltblown/Spunbond design (SFSMS) that provides AAMI Level 3 liquid barrier protection in the critical zone of the gown. The back of the gown is a SMS (spunbond/meltblown/spunbond fabric that is air-breathable and provides AAMI Level 1 liquid barrier protection.
Acceptance Criteria and Device Performance Study for Aero Blue* Performance Surgical Gowns
This document outlines the acceptance criteria and the study that demonstrates the Aero Blue* Performance Surgical Gowns meet these criteria, based on the provided 510(k) summary (K140539).
1. Acceptance Criteria and Reported Device Performance
The Aero Blue* Performance Surgical Gowns are designed to meet the Level 3 requirements of the AAMI PB70: 2012 Liquid Barrier classifications in the critical zone, and Level 1 in the non-critical back zone. The non-clinical testing performed demonstrated compliance with these and other relevant standards.
| Standard or Reference | Test Method | Acceptance Criteria (Implied by standard and intended use) | Reported Device Performance |
|---|---|---|---|
| Standard for the Flammability for Clothing Textiles | 16 CFR 1610 | Meet Class 1 Flammability requirements. | Pass |
| ISO 10993-5:2009 Biological Evaluation of Medical Devices - Part 5 | Cytotoxicity | No significant cytotoxic effects. | Pass |
| ISO 10993-10:2010 Biological Evaluation of Medical Devices - Part 10 | Skin Irritation Study | No significant skin irritation. | Pass |
| ISO 10993-10:2010 Biological Evaluation of Medical Devices - Part 10 | Sensitization Test | No significant sensitization. | Pass |
| ISO 10993-7:2008, Ethylene Oxide sterilization residuals | EO residuals | EO residuals within acceptable limits for a surface device with limited contact with breached or compromised surfaces. | Pass |
| Laser Ignition Resistance | ISO 11810-1 (2005) | Demonstrate resistance to laser ignition. | Pass |
| Spray Impact (critical zones) | AATCC 42:2007 | Demonstrate water resistance in the critical zones consistent with AAMI Level 3. | Pass |
| Liquid Barrier Performance | AAMI PB70:2012 Level 3 | Critical Zone: Meet Level 3 liquid barrier performance (SFSMS design). (Implied: Resist liquid penetration under specific conditions, including spray impact and hydrostatic pressure.) Non-Critical Zone (back): Meet Level 1 liquid barrier performance (SMS fabric). (Implied: Provide minimum liquid barrier protection.) | Pass |
| Hydrostatic Head (critical zones) | AATCC 127:2008 | Demonstrate water resistance under hydrostatic pressure in the critical zones consistent with AAMI Level 3. | Pass |
| Spray Impact (non-critical zones) | AATCC 42:2007 | Demonstrate water resistance in the non-critical zones consistent with AAMI Level 1. | Pass |
| Grab Tensile, Peak Stretch, and Peak Energy - Nonwovens | ASTM D5034 (2009) | Possess adequate tensile strength for intended use. | Pass |
| Abrasion Resistance and Surface Bonding of SMS Laminates | WSP 20.5 (2008) | Demonstrate adequate abrasion resistance and surface bonding. | Pass |
| Synthetic Blood Penetration | ASTM-1670-08 (2008) | Resist penetration by synthetic blood in the critical zone. | Pass |
| Mass Per Area (Basis Weight) of Materials | D3776 (2009) | Maintain consistent fabric basis weight as specified. | Pass |
| Water Vapor Transmission Rate Through Nonwovens and Plastic Films | WSP 70.4 (2008) | Demonstrate appropriate water vapor transmission rate for breathability. | Pass |
| Degree Peel Strength of Laminated Nonwovens - Raw Materials | STM-00197(2010) | Achieve adequate peel strength for laminated components. | Pass |
| Resistance to Linting Dry Particle Generation | INDA WSP 160.1 (2009) | Demonstrate resistance to linting and dry particle generation. | Pass |
Note: The document explicitly states "All results of testing met acceptance criteria." This implies that the device performed within the established limits for each test.
2. Sample Size Used for the Test Set and Data Provenance
The 510(k) summary does not specify the exact sample sizes used for each individual non-clinical test. It lists the standards and test methods applied. For instance, for liquid barrier and blood penetration, it refers to standards like AAMI PB70:2012 and ASTM F-1670-08. These standards typically define minimum sample sizes for testing to ensure statistical validity.
The data provenance is retrospective, as the tests were conducted on the manufactured Aero Blue* Performance Surgical Gowns to demonstrate compliance with established standards. The country of origin of the data is not explicitly stated but is implicitly from the manufacturer's testing facilities or accredited third-party labs where these standards are tested, likely within the US given the submission to the FDA.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This section is not applicable for this medical device. The "ground truth" for the performance of a surgical gown is established by objective, standardized test methods and criteria defined by recognized national and international standards organizations (e.g., AAMI, ASTM, ISO, CPSC). These standards specify the methodology, equipment, and acceptable limits for performance. There is no human expert "ground truth" to be established in the context of device performance testing for surgical gowns.
4. Adjudication Method for the Test Set
Adjudication methods like 2+1 or 3+1 are typically used in clinical studies or image-based diagnostic device evaluations where expert consensus is needed to establish ground truth. As noted above, the performance of a surgical gown is evaluated against predefined objective criteria and standardized test results. Therefore, no human adjudication method was employed or is relevant for this type of device testing.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
An MRMC study is not applicable and was not done. This type of study assesses the impact of a device (often an AI algorithm) on human reader performance, typically in diagnostic imaging. The Aero Blue* Performance Surgical Gowns are barrier garments, not diagnostic tools, and do not involve human "readers" or AI assistance in their function.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
A standalone study of an algorithm is not applicable and was not done. The Aero Blue* Performance Surgical Gown is a physical medical device, not an algorithm or software. Its performance is evaluated directly through physical and material property tests.
7. The Type of Ground Truth Used
The ground truth used for the device's performance claims is based on objective, quantitative measurements and qualitative assessments derived from recognized industry standards and test methods. Specifically:
- Standardized Test Data: The "Pass" results in the "Summary of Non-Clinical Testing" indicate that the device met the precise, objective criteria set forth by each referenced standard (e.g., AAMI PB70:2012 for liquid barrier, ASTM-1670-08 for synthetic blood penetration, ISO 10993 for biocompatibility).
- Performance Metrics: The "ground truth" is defined by specific physical and material properties (e.g., water resistance, tensile strength, flammability, cytotoxicity) measured against predefined thresholds in the standards.
8. Sample Size for the Training Set
A "training set" is not applicable to this device. Training sets are used in the development of machine learning algorithms. The Aero Blue* Performance Surgical Gowns are physical products whose performance is determined by their material composition, design, and manufacturing processes, and subsequently validated through non-clinical laboratory testing.
9. How the Ground Truth for the Training Set Was Established
This question is not applicable as there is no training set for this device. The physical and chemical properties of the materials, and thus the performance characteristics of the gown, are established through material science, engineering, and validated test methods, not through an iterative process of training an algorithm on a dataset with established ground truth.
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JUN 0 9 2014
EB Kimberly-Clark Corporation
510K Summary
May 8, 2014 Date Summarv was Prepared:
510(k) David M. Lee. JD Associate Director of Regulatory Affairs Submitter: Kimberly-Clark Health Care 1400 Holcomb Bridge Road Bldg. 300/1 Roswell, GA 30076 770-587-7167 David.m.lee@kcc.com
Primary Contact David M. Lee, JD for this 510(k) Associate Director of Regulatory Affairs Submission: Kimberly-Clark Health Care 1400 Holcomb Bridge Road Bldg. 300/1 Roswell, GA 30076 770-587-7167 David.m.lee@kcc.com
Device Trade Aero Blue* Performance Surgical Gowns Name:
Device Common Surgical Gown Names
- Device Product FYA Codes and Class II Classification Surgical Gown Names:
Predicate The Aero Blue* Performance Surgical Gowns under submission are Devices substantially equivalent to the predicate device, the Microcool Breathable High Performance Surgical Gowns (K103406).
Device A Spunbond/Film/Spunbond/Meltblown/Spunbond design (SFSMS) that Description: provides AAMI Level 3 liquid barrier protection in the critical zone of the gown. The back of the gown is a SMS (spunbond/meltblown/spunbond fabric that is air-breathable and provides AAMI Level 1 liquid barrier protection.
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| IntendedUse: | The Aero Blue* Performance Surgical Gowns are sterile, single use surgicalapparel intended to be worn by healthcare professionals to help protect boththe patient and the healthcare worker from the transfer of microorganisms,body fluids, and particulate matter. The Aero Blue* Performance SurgicalGowns meet the Level 3 requirements of the AAMI PB70: 2012 Liquid Barrierclassifications. |
|---|---|
| The Aero Blue* Performance Surgical Gowns are also sold as bulk non-sterile,single use items, to repackager/relabeler establishments for furtherpackaging and Ethylene Oxide (EtO) sterilization. | |
| TechnologicalCharacteristicsand SubstantiaEquivalence: | The Kimberly-Clark* Aero Blue* Performance Surgical Gowns aresubstantially equivalent to the predicate device, the Microcool Breathable HighPerformance Surgical Gowns (K103406), in intended use, design, performanceand manufacturing processes. Both gowns incorporate a film laminate fabric inthe gown critical zone. The primary differences are that the Aero Blue*Performance Surgical Gowns provide AAMI PB70:2012 Level 3 liquid barrierprotection in the critical zone, while the predicate gown provides AAMI Level 4protection, and the Aero Blue* Performance Surgical Gowns incorporate inthe back of the gown a breathable SMS fabric providing AAMI Level 1protection. The Aero Blue* Performance Surgical Gowns fabric in thecritical zone also complies with ASTM F-1670-08 Standard Test Method forResistance of Materials Used in Protective Clothing to Penetration by SyntheticBlood. The above differences in design and AAMI liquid protection level raiseno new issues of safety and efficacy since the Aero Blue* PerformanceSurgical Gowns are designed, tested, and labeled in compliance with theAAMI PB70: 2012 Liquid Barrier Level 3 liquid barrier requirements. |
| Summary ofNon-ClinicalTesting: | The Aero Blue* Performance Surgical Gowns have been tested forcompliance in the critical zone with the requirements of Level 3 liquid barrierperformance requirements of ANSI/AAMI PB70: 2012 "Liquid barrierperformance and classification of protective apparel and drapes intended foruse in health care facilities". The back of the gown, which is in the non-criticalzone, provides ANSI/AAMI PB70: 2012 Level 1 liquid barrier protection. TheAero Blue* Performance Surgical Gowns also meet ASTM F1670-08;Standard Test Method for Resistance of Materials Used in Protective Clothingto Penetration by Synthetic Blood in the critical zone fabric. The Aero Blue*Performance Surgical Gowns also meet the requirements of Flame ResistantCPSC 1610 Class 1. The Aero Blue* Performance Surgical Gown has alsobeen tested in compliance with the biocompatibility requirements of ISO 10993for surface devices with limited contact with breached or compromisedsurfaces. The Aero Blue* Performance Surgical Gowns are also tested incompliance with ISO 11810 for resistance to laser ignition. |
All results of testing met acceptance criteria
:
.
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Summary of Non-Clinical Testing
| Standard or Reference | Test Method | Data Generated | MeetsRequirement |
|---|---|---|---|
| Standard for the Flammability forClothing Textiles | 16 CFR 1610 | Flammability | Pass |
| ISO 10993-5:2009 BiologicalEvaluation of Medical Devices-Part 5: | Cytotoxicity | Cytotoxicity | Pass |
| ISO 10993-10:2010 BiologicalEvaluation of Medical Devices-Part 10 | Skin Irritation Study | Irritation | Pass |
| ISO 10993-10:2010 BiologicalEvaluation of Medical Devices-Part 10 | Sensitization Test | Sensitization | Pass |
| ISO 10993-7:2008, EthyleneOxide sterilization residuals | EO residuals | EO residuals | Pass |
| Laser Ignition Resistance | ISO 11810-1 (2005) | Laser resistance | Pass |
| Spray Impact(critical zones) | AATCC 42:2007 | Water resistance | Pass |
| Liquid Barrier Performance | AAMI PB70:2012Level 3 | Water Resistance | Pass |
| Hydrostatic Head(critical zones) | AATCC 127:2008 | Water resistance | Pass |
| Spray Impact(non- critical zones) | AATCC 42:2007 | Water resistance | Pass |
| Grab Tensile, Peak Stretch, andPeak Energy - Nonwovens | ASTM D5034(2009) | Tensile Strength | Pass |
| Abrasion Resistance and SurfaceBonding of SMS Laminates | WSP 20.5 (2008) | Abrasion resistance | Pass |
| Synthetic Blood Penetration | ASTM-1670-08(2008) | Resistance topenetration | Pass |
| Mass Per Area (Basis Weight) ofMaterials | D3776 (2009) | Fabric basis weight | Pass |
| Water Vapor Transmission RateThrough Nonwovens and PlasticFilms | WSP70.4 (2008) | Water VaporTransmission | Pass |
| Degree Peel Strength ofLaminated Nonwovens - RawMaterials | STM-00197(2010) | Peel Strength | Pass |
| Resistance to Linting Dry ParticleGeneration | INDA WSP 160.1(2009) | Particulate | Pass |
Substantial Equivalence Table
| Attribute | Predicate Device:Kimberly-ClarkMicroCoolBreathable High PerformanceSurgical Gown K103406, (AAMILiquid Barrier Level 4) | Subject of this 510(k):K140539 Aero Blue* PerformanceSurgical Gown, (AAMI LiquidBarrier Level 3) |
|---|---|---|
| Indicationsfor Use | Kimberly-Clark* MicroCool* SurgicalGowns, are sterile, single use surgicalapparel intended to be worn byhealthcare professionals to help | Aero Blue* Surgical Gowns, aresterile, single use surgical apparelintended to be worn by healthcareprofessionals to help protect both the |
| Attribute | Predicate Device:Kimberly-ClarkMicroCoolBreathable High PerformanceSurgical Gown K103406, (AAMILiquid Barrier Level 4) | Subject of this 510(k):K140539 Aero Blue* PerformanceSurgical Gown, (AAMI LiquidBarrier Level 3) |
| protect both the patient and thehealthcare worker from the transfer ofmicroorganisms, body fluids, andparticulate matter.The MicroCool* Surgical Gown meetthe Level 4 requirements of the AAMILiquid Barrier classifications.The Kimberly-Clark* MicroCool*Surgical Gowns, are also sold as bulknon-sterile, single use items, torepackager/relabeler establishmentsfor further packaging and EthyleneOxide (EtO) sterilization. | patient and the healthcare workerfrom the transfer of microorganisms,body fluids, and particulate matter.The Aero Blue* PerformanceSurgical Gowns meet the Level 3requirements of the AAMI PB70:2012 Liquid Barrier classifications.The Aero Blue* Surgical Gowns, arealso sold as bulk non-sterile, singleuse items, to repackager/relabelerestablishments for further packagingand Ethylene Oxide (EtO)sterilization. | |
| Howsupplied | Sterile (10-6) or bulk non-sterile | Same |
| SterilizationMethod | Ethylene Oxide | Same |
| SAL | 10-6 | Same |
| Gown color | Blue | Same |
| Gown sizes | Small, Large, X-Large, XX-Large,XXX-Large | Same |
| ConstructionOverview | The MicroCool* Breathable HighPerformance Surgical Gown ismanufactured from a breathable,repellent, non-woven, polypropylenefabric. The gown is constructed from aspunbond/film/spunbond/meltblown/spunbond (SFSMS) design that isadhesively laminated. The gownmeets AAMI-4 liquid barrierrequirements | The Aero Blue* PerformanceSurgical Gown under submission ismanufactured from a moisture-vaporbreathable, repellent, non-wovenfabric using a polymer blend ofpolypropylene and polyethylene.The front body and sleeve fabric is athree layer film laminate. This fabricis an SFSMS design Spunbond/Film/Spunbond-Meltblown-Spunbond that is adhesively bondedtogether. Front of Gown meetsmeet AAMI-3 liquid barrierrequirements, while back of Gown inthe non-critical zone is composed ofa breathable SMS fabric with anAAMI level 1 liquid barrier protection |
| Does notcontainNaturalRubberLatex | Yes | Same |
| PerformanceTesting | ANSI/AAMI PB70: 2003 Level 4 LiquidBarrier Requirements - Pass | N/A |
| ANSI/AAMI PB70: 2012 Level 3 LiquidBarrier Requirements - N/A | ANSI/AAMI PB70: 2012 Level 3Liquid Barrier Requirements - Pass | |
| RTM - 6405/STM00204/WSP 70.42008 -Water Vapor Transmission Rateof Materials - Pass | Same | |
| RTM 6176/WSP 160.1 2009 - TestMethod for Resistance to Linting -Pass | Same | |
| ASTM D 5034 - 2009 Standard TestMethod For Breaking Strength andElongation of Textile Fabrics (GrabTest) - Pass | Same | |
| Peel Strength - EQ-STM5671/STM00197 2010 - Pass | Same | |
| Hydrohead Low Surface Tension EQ-STM 4507-2012 Pass | Same | |
| STM- 00149 (ASTM-4966/WSP 20.52008, Abrasion Test - Pass | Same | |
| Biocompatibility - Pass | Same | |
| 16 CFR, Chapter II--ConsumerProduct Safety Commission Part 1610-Standard For The Flammability ofClothing Textiles Class I - Pass | Same |
.
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:
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:
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- Conclusion The performance testing submitted for the Aero Blue* Performance Surgical Gowns demonstrates substantial equivalence to the predicate Kimberly Clark* Microcool* Breathable High Performance Surgical Gown (K103406) in intended use, design, materials, performance and biocompatibility attributes.
*Registered Trademark or Trademark of Kimberly-Clark Worldwide, Inc. or its affiliates.
·
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MID 20993-000
June 9, 2014
Kimberly-Clark Corporation David M. Lee. JD Associate Director of Regulatory Affairs Bldg. 300/l 1400 Holcomb Bridge Road Roswell. Georgia 30076
Re: K140539
ﺘ
Trade/Device Name: Acro Blue Performance Surgical Gowns Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical Gown Regulatory Class: Class II Product Code: FYA Dated: May 8, 2014 Received: May 9, 2014
Dear Mr. 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.
Image /page/5/Picture/10 description: The image shows the seal of the Department of Health & Human Services USA. The seal is circular with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread.
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Page 2 - Mr. Lee
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) 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 Small Manufacturers, International and Consumer Assistance at its tollfree 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" (21CFR 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 Small Manufacturers, International and Consumer Assistance 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,
Tejastri Purobit-Sheth, M.D. Toiashri Provisit-Sheth, M.D. Clinical Deputy Director DAGRID/ODE/CDRH FOR
Erin I. Keith, M.S. 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 on last page.
510(k) Number (if known)
K140539
Device Name
Aero Blue* Performance Surgical Gowns
Indications for Use (Describe)
Intended Use: The Aero Blue* Performance Surgical Gowns are sterile, single use surgical apparel intended to be worn by healthcare professionals to help protect both the patient and the healthcare worker from the transfer of microorganisms, body fluids, and particulate matter.
The Aero Blue* Performance Surgical Gowns meet the Level 3 requirements of the AAMI PB70: 2012 Liquid Barrier classifications.
The Aero Blue* 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.
Type of Use (Select one or both, as applicable)
□ Prescription Use (Part 21 CFR 801 Subpart D)
7% Over-The-Counter Use (21 CFR 801 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
| FOR FDA USE ONLY | ||
|---|---|---|
| Concurrence of Center for Devices and Radiological Health (CDRH) (Signature) | Elizabeth F.Claverie -S | Digitally signed by Elizabeth F. Claverie -SDN: c=US, o=U.S. Government, ou=HHS,ou=FDA, ou=People,0.9.2342.19200300.100.1.1=1300055864,cn=Elizabeth F. Claverie -SDate: 2014.06.06 12:04:26 -04'00' |
FORM FDA 3881 (1/14)
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The Aero Blue* Performance Surgical Gowns product codes, sizes, and a brief product description are provided below.
STERILE PRODUCT
Code
| Product Description | |
|---|---|
| 41732 | Aero Blue Performance Surgical Gown, Small/Medium, Sterile |
| 41733 | Aero Blue Performance Surgical Gown, Large, Sterile |
| 41734 | Aero Blue Performance Surgical Gown, X-Large, Sterile |
| 41735 | Aero Blue Performance Surgical Gown, XX-Large, Sterile |
| 41736 | Aero Blue Performance Surgical Gown, XXX-Large, Sterile |
| 41724 | Aero Blue Performance Surgical Gown, X-Long, Large, Sterile |
| 41726 | Aero Blue Performance Surgical Gown, X-Long, X-Large, Sterile |
NON-STERILE PRODUCT
Product Code
Product Description
| 41739 | Aero Blue Performance Surgical Gown, Large |
|---|---|
| 41737 | Aero Blue Performance Surgical Gown, Large Handi-Bin |
| 41738 | Aero Blue Performance Surgical Gown, X-Large, Handi-Bin |
| 41740 | Aero Blue Performance Surgical Gown, X-Large |
| 41741 | Aero Blue Performance Surgical Gown, XX-Large |
| 41722 | Aero Blue Performance Surgical Gown in Overwrap, Large, Handi-Bin |
| 41723 | Aero Blue Performance Surgical Gown in Overwrap, X-Large, Handi-Bin |
| 41725 | Aero Blue Performance Surgical Gown, X-Long Large |
| 41727 | Aero Blue Performance Surgical Gown, X-Long, X-Large |
This section applies only to requirements of the Paperwork Reduction Act of 1995.
*DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW."
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"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
§ 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.