AERO BLUE PERFORMANCE SURGICAL GOWN
Device Facts
| Record ID | K140539 |
|---|---|
| Device Name | AERO BLUE PERFORMANCE SURGICAL GOWN |
| Applicant | Kimberly-Clark Corporation |
| Product Code | FYA · General, Plastic Surgery |
| Decision Date | Jun 9, 2014 |
| Decision | SESE |
| Submission Type | Abbreviated |
| Regulation | 21 CFR 878.4040 |
| Device Class | Class 2 |
Indications for Use
The Aero Blue* Performance Surgical Gowns are sterile, single use surgical apparel intended to be worn by healthcare professionals to help protect both the patient and the healthcare worker from the transfer of microorganisms, body fluids, and particulate matter. The Aero Blue* Performance Surgical Gowns meet the Level 3 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.
Device Story
Surgical gown providing AAMI Level 3 liquid barrier protection in critical zones and AAMI Level 1 protection in non-critical back zones; constructed from SFSMS (spunbond/film/spunbond/meltblown/spunbond) laminate in critical areas and breathable SMS fabric in back; intended for use by healthcare professionals in surgical settings to prevent cross-contamination of microorganisms, fluids, and particulates; supplied sterile or as bulk non-sterile items for repackaging/sterilization; provides physical barrier protection; benefits patient and healthcare worker by reducing infection transmission risk.
Clinical Evidence
Bench testing only. Compliance demonstrated with ANSI/AAMI PB70:2012 (Level 3 critical zone, Level 1 non-critical zone), ASTM F1670-08 (synthetic blood penetration), CPSC 1610 (flammability), ISO 10993 (biocompatibility), and ISO 11810 (laser ignition resistance). All testing met acceptance criteria.
Technological Characteristics
Materials: Polypropylene/polyethylene polymer blend. Design: SFSMS (spunbond/film/spunbond/meltblown/spunbond) laminate in critical zones; SMS in non-critical zones. Standards: AAMI PB70:2012, ASTM F1670-08, CPSC 1610, ISO 10993, ISO 11810. Sterilization: Ethylene Oxide (EtO).
Indications for Use
Indicated for use by healthcare professionals as sterile, single-use surgical apparel to protect patients and workers from microorganisms, body fluids, and particulate matter.
Regulatory Classification
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.
Special Controls
*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.
Predicate Devices
- Microcool Breathable High Performance Surgical Gowns (K103406)
Submission Summary (Full Text)
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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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| Intended<br>Use: | The Aero Blue* Performance Surgical Gowns are sterile, single use surgical<br>apparel intended to be worn by healthcare professionals to help protect both<br>the patient and the healthcare worker from the transfer of microorganisms,<br>body fluids, and particulate matter. The Aero Blue* Performance Surgical<br>Gowns meet the Level 3 requirements of the AAMI PB70: 2012 Liquid Barrier<br>classifications. |
|--------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | The Aero Blue* Performance Surgical Gowns are also sold as bulk non-sterile,<br>single use items, to repackager/relabeler establishments for further<br>packaging and Ethylene Oxide (EtO) sterilization. |
| Technological<br>Characteristics<br>and Substantia<br>Equivalence: | The Kimberly-Clark* Aero Blue* Performance Surgical Gowns are<br>substantially equivalent to the predicate device, the Microcool Breathable High<br>Performance Surgical Gowns (K103406), in intended use, design, performance<br>and manufacturing processes. Both gowns incorporate a film laminate fabric in<br>the gown critical zone. The primary differences are that the Aero Blue*<br>Performance Surgical Gowns provide AAMI PB70:2012 Level 3 liquid barrier<br>protection in the critical zone, while the predicate gown provides AAMI Level 4<br>protection, and the Aero Blue* Performance Surgical Gowns incorporate in<br>the back of the gown a breathable SMS fabric providing AAMI Level 1<br>protection. The Aero Blue* Performance Surgical Gowns fabric in the<br>critical zone also complies with ASTM F-1670-08 Standard Test Method for<br>Resistance of Materials Used in Protective Clothing to Penetration by Synthetic<br>Blood. The above differences in design and AAMI liquid protection level raise<br>no new issues of safety and efficacy since the Aero Blue* Performance<br>Surgical Gowns are designed, tested, and labeled in compliance with the<br>AAMI PB70: 2012 Liquid Barrier Level 3 liquid barrier requirements. |
| Summary of<br>Non-Clinical<br>Testing: | The Aero Blue* Performance Surgical Gowns have been tested for<br>compliance in the critical zone with the requirements of Level 3 liquid barrier<br>performance requirements of ANSI/AAMI PB70: 2012 "Liquid barrier<br>performance and classification of protective apparel and drapes intended for<br>use in health care facilities". The back of the gown, which is in the non-critical<br>zone, provides ANSI/AAMI PB70: 2012 Level 1 liquid barrier protection. The<br>Aero Blue* Performance Surgical Gowns also meet ASTM F1670-08;<br>Standard Test Method for Resistance of Materials Used in Protective Clothing<br>to Penetration by Synthetic Blood in the critical zone fabric. The Aero Blue*<br>Performance Surgical Gowns also meet the requirements of Flame Resistant<br>CPSC 1610 Class 1. The Aero Blue* Performance Surgical Gown has also<br>been tested in compliance with the biocompatibility requirements of ISO 10993<br>for surface devices with limited contact with breached or compromised<br>surfaces. The Aero Blue* Performance Surgical Gowns are also tested in<br>compliance 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 | Meets<br>Requirement |
|---------------------------------------------------------------------------|---------------------------|------------------------------|----------------------|
| Standard for the Flammability for<br>Clothing Textiles | 16 CFR 1610 | Flammability | Pass |
| ISO 10993-5:2009 Biological<br>Evaluation of Medical Devices-<br>Part 5: | Cytotoxicity | Cytotoxicity | Pass |
| ISO 10993-10:2010 Biological<br>Evaluation of Medical Devices-<br>Part 10 | Skin Irritation Study | Irritation | Pass |
| ISO 10993-10:2010 Biological<br>Evaluation of Medical Devices-<br>Part 10 | Sensitization Test | Sensitization | Pass |
| ISO 10993-7:2008, Ethylene<br>Oxide sterilization residuals | EO residuals | EO residuals | Pass |
| Laser Ignition Resistance | ISO 11810-1 (2005) | Laser resistance | Pass |
| Spray Impact<br>(critical zones) | AATCC 42:2007 | Water resistance | Pass |
| Liquid Barrier Performance | AAMI PB70:2012<br>Level 3 | Water Resistance | Pass |
| Hydrostatic Head<br>(critical zones) | AATCC 127:2008 | Water resistance | Pass |
| Spray Impact<br>(non- critical zones) | AATCC 42:2007 | Water resistance | Pass |
| Grab Tensile, Peak Stretch, and<br>Peak Energy - Nonwovens | ASTM D5034<br>(2009) | Tensile Strength | Pass |
| Abrasion Resistance and Surface<br>Bonding of SMS Laminates | WSP 20.5 (2008) | Abrasion resistance | Pass |
| Synthetic Blood Penetration | ASTM-1670-08<br>(2008) | Resistance to<br>penetration | Pass |
| Mass Per Area (Basis Weight) of<br>Materials | D3776 (2009) | Fabric basis weight | Pass |
| Water Vapor Transmission Rate<br>Through Nonwovens and Plastic<br>Films | WSP<br>70.4 (2008) | Water Vapor<br>Transmission | Pass |
| Degree Peel Strength of<br>Laminated Nonwovens - Raw<br>Materials | STM-00197(2010) | Peel Strength | Pass |
| Resistance to Linting Dry Particle<br>Generation | INDA WSP 160.1<br>(2009) | Particulate | Pass |
# Substantial Equivalence Table
| Attribute | Predicate Device:<br>Kimberly-Clark*MicroCool*<br>Breathable High Performance<br>Surgical Gown K103406, (AAMI<br>Liquid Barrier Level 4) | Subject of this 510(k):<br>K140539 Aero Blue* Performance<br>Surgical Gown, (AAMI Liquid<br>Barrier Level 3) |
|---------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications<br>for Use | Kimberly-Clark* MicroCool* Surgical<br>Gowns, are sterile, single use surgical<br>apparel intended to be worn by<br>healthcare professionals to help | Aero Blue* Surgical Gowns, are<br>sterile, single use surgical apparel<br>intended to be worn by healthcare<br>professionals to help protect both the |
| | | |
| Attribute | Predicate Device:<br>Kimberly-Clark*MicroCool*<br>Breathable High Performance<br>Surgical Gown K103406, (AAMI<br>Liquid Barrier Level 4) | Subject of this 510(k):<br>K140539 Aero Blue* Performance<br>Surgical Gown, (AAMI Liquid<br>Barrier Level 3) |
| | protect both the patient and the<br>healthcare worker from the transfer of<br>microorganisms, body fluids, and<br>particulate matter.<br>The MicroCool* Surgical Gown meet<br>the Level 4 requirements of the AAMI<br>Liquid Barrier classifications.<br>The Kimberly-Clark* MicroCool*<br>Surgical Gowns, are also sold as bulk<br>non-sterile, single use items, to<br>repackager/relabeler establishments<br>for further packaging and Ethylene<br>Oxide (EtO) sterilization. | patient and the healthcare worker<br>from the transfer of microorganisms,<br>body fluids, and particulate matter.<br>The Aero Blue* Performance<br>Surgical Gowns meet the Level 3<br>requirements of the AAMI PB70:<br>2012 Liquid Barrier classifications.<br>The Aero Blue* Surgical Gowns, are<br>also sold as bulk non-sterile, single<br>use items, to repackager/relabeler<br>establishments for further packaging<br>and Ethylene Oxide (EtO)<br>sterilization. |
| How<br>supplied | Sterile (10-6) or bulk non-sterile | Same |
| Sterilization<br>Method | Ethylene Oxide | Same |
| SAL | 10-6 | Same |
| Gown color | Blue | Same |
| Gown sizes | Small, Large, X-Large, XX-Large,<br>XXX-Large | Same |
| Construction<br>Overview | The MicroCool* Breathable High<br>Performance Surgical Gown is<br>manufactured from a breathable,<br>repellent, non-woven, polypropylene<br>fabric. The gown is constructed from a<br>spunbond/film/spunbond/meltblown/sp<br>unbond (SFSMS) design that is<br>adhesively laminated. The gown<br>meets AAMI-4 liquid barrier<br>requirements | The Aero Blue* Performance<br>Surgical Gown under submission is<br>manufactured from a moisture-vapor<br>breathable, repellent, non-woven<br>fabric using a polymer blend of<br>polypropylene and polyethylene.<br>The front body and sleeve fabric is a<br>three layer film laminate. This fabric<br>is an SFSMS design Spunbond/<br>Film/Spunbond-Meltblown-<br>Spunbond that is adhesively bonded<br>together. Front of Gown meets<br>meet AAMI-3 liquid barrier<br>requirements, while back of Gown in<br>the non-critical zone is composed of<br>a breathable SMS fabric with an<br>AAMI level 1 liquid barrier protection |
| Does not<br>contain<br>Natural<br>Rubber<br>Latex | Yes | Same |
| Performance<br>Testing | ANSI/AAMI PB70: 2003 Level 4 Liquid<br>Barrier Requirements - Pass | N/A |
| | ANSI/AAMI PB70: 2012 Level 3 Liquid<br>Barrier Requirements - N/A | ANSI/AAMI PB70: 2012 Level 3<br>Liquid Barrier Requirements - Pass |
| | RTM - 6405/STM00204/WSP 70.4<br>2008 -Water Vapor Transmission Rate<br>of Materials - Pass | Same |
| | RTM 6176/WSP 160.1 2009 - Test<br>Method for Resistance to Linting -<br>Pass | Same |
| | ASTM D 5034 - 2009 Standard Test<br>Method For Breaking Strength and<br>Elongation of Textile Fabrics (Grab<br>Test) - Pass | Same |
| | Peel Strength - EQ-STM<br>5671/STM00197 2010 - Pass | Same |
| | Hydrohead Low Surface Tension EQ-<br>STM 4507-2012 Pass | Same |
| | STM- 00149 (ASTM-4966/WSP 20.5<br>2008, Abrasion Test - Pass | Same |
| | Biocompatibility - Pass | Same |
| | 16 CFR, Chapter II--Consumer<br>Product Safety Commission Part 1610<br>-Standard For The Flammability of<br>Clothing Textiles Class I - Pass | Same |
.
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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.<br>Claverie -S | Digitally signed by Elizabeth F. Claverie -S<br>DN: c=US, o=U.S. Government, ou=HHS,<br>ou=FDA, ou=People,<br>0.9.2342.19200300.100.1.1=1300055864,<br>cn=Elizabeth F. Claverie -S<br>Date: 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 |
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