(34 days)
Not Found
No
The document describes a surgical gown and its material properties and performance testing, with no mention of AI or ML.
No
Explanation: This device is a surgical gown intended to protect healthcare professionals and patients from contamination, not to treat or cure a disease or condition.
No
The device described is a surgical gown, which is a protective apparel, not a diagnostic tool. Its purpose is to create a barrier and protect against microorganisms and fluids, not to diagnose medical conditions.
No
The device description clearly outlines the physical materials and construction of a surgical gown, which is a hardware medical device. There is no mention of software components.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the gowns are "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." This describes a barrier device for personal protection, not a device used to examine specimens derived from the human body to provide information for diagnosis, monitoring, or treatment.
- Device Description: The description focuses on the physical construction and materials of the gown, emphasizing its barrier properties.
- Performance Studies: The performance studies described relate to barrier performance against liquids and pathogens, flame resistance, and biocompatibility for skin contact. These are relevant to protective apparel, not diagnostic testing.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, detecting analytes, or providing diagnostic information.
Therefore, the Kimberly-Clark* MicroCool* Breathable High Performance Surgical Gowns are classified as protective apparel, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Kimberly-Clark* MicroCool* Breathable High 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 MicroCool* Breathable High Performance Surgical Gowns meet the Level 4 requirements of the AAMI Liquid Barrier classifications.
The Kimberly-Clark* MicroCool* Breathable High Performance Surqical Gowns, are also sold as bulk non-sterile, single use items, to repackager/relabeler establishments for further packaging and Ethylene Oxide (EtO) sterilization.
Product codes
FYA
Device Description
The MicroCool* Breathable High Performance Surgical Gowns are manufactured from a breathable, repellent, non-woven, polypropylene fabric. The fabric is a three-layer lamination that resists tearing and penetration by liquids. The gown is constructed from a spunbond/film/spunbond/meltblown/spunbond (SFSMS) design. The film layer is a multi-layer polypropylenebased, breathable film. A C6 fluorochemical treatment is added to the film to retard penetration by low surface tension fluids. A polyolefin hot melt adhesive is used to laminate the facing layers. to the film layer to complete the composite.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
Not Found
Intended User / Care Setting
healthcare professionals
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The Kimberly-Clark* MicroCool* Breathable High Performance Surgical Gown, has been tested in compliance with the requirements of Level 4 liquid barrier performance requirements of ANSI/AAMI PB70: 2003 "Liquid barrier performance and classification of protective apparel and drapes intended for use in health care facilities." The MicroCool* Breathable High Performance Surgical Gown also meets the requirements of ASTM1671:2003 Standard test method for resistance of materials used in protective clothing to penetration by blood-borne pathogens using Phi-X174 bacteriophage penetration as a test system. The MicroCool* Breathable High Performance Surgical Gown meets the requirements of Flame Resistant CPSC 1610 Class 1. The MicroCool* Breathable High Performance Surgical Gown has also been tested in compliance with the biocompatibility requirements of ISO 10993 for surface devices with limited contact with breached or compromised surfaces. All results of testing met acceptance criteria.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
K103406
510(k) Summary for the Kimberly-Clark* Corporation MicroCool Breathable High Performance Surgical Gown with AAMI Liquid Barrier Level 4 claim
Date Summary was December 13, 2010 Prepared:
17
- 510(k) Submitter: David M. Lee. J.D. Associate Director of Regulatory Affairs Kimberly-Clark Health Care 1400 Holcomb Bridge Road Roswell, GA 30076 Ph: 770.587.7167 FAX: 920.225.4784 Email: David.Lee@kcc.com
- Primary Contact David M. Lee, J.D. for this 510(k) Associate Director of Regulatory Affairs Submission: Kimberly-Clark Health Care 1400 Holcomb Bridge Road Roswell, GA 30076 Ph: 770.587.7167 FAX: 920. 225.4784 Email: David.Lee@kcc.com
- Device Trade Kimberly-Clark* MicroCool Breathable High Performance Name: Surgical Gown.
- Device Common names Sterile surgical gown
Names:
- Device Product FYA, Class II Codes and Surgical Gowns (21 CFR 878.4040) Classification
- The predicate device for this Kimberly-Clark*MicroCool Predicate Devices Breathable High Performance Surgical Gown submission is K091357, the Kimberly-Clark MicroCool Surgical Gown, Breathable High Performance, KC400
The MicroCool* Breathable High Performance Surgical Gowns are Device manufactured from a breathable, repellent, non-woven, Description: polypropylene fabric. The fabric is a three-layer lamination that resists tearing and penetration by liquids. The gown is constructed from a spunbond/film/spunbond/meltblown/spunbond (SFSMS) design. The film layer is a multi-layer polypropylenebased, breathable film. A C6 fluorochemical treatment is added to the film to retard penetration by low surface tension fluids. A polyolefin hot melt adhesive is used to laminate the facing layers. to the film layer to complete the composite.
1
| Intended Use: | The Kimberly-Clark* MicroCOOL* Breathable High 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 MicroCool* Breathable High Performance Surgical Gowns meet the Level 4 requirements of the AAMI Liquid Barrier classifications. |
|---|---|
| The Kimberly-Clark* MicroCool* Breathable High Performance Surqical Gowns, are also sold as bulk non-sterile, single use items, to repackager/relabeler establishments for further packaging and Ethylene Oxide (EtO) sterilization | |
| Technological | |
| Characteristics and | |
| Substantial | |
| Equivalence: | The MicroCool* Breathable High Performance Surgical Gown, that is the subject of this 510(k) is substantially equivalent to the predicate KIMBERLY-CLARK* MICROCOOL SURGICAL GOWN. BREATHABLE HIGH PERFORMANCE, KC400 (K091357) in intended use, design, and biocompatibility attributes. The performance attributes of the MicroCool* Breathable High Performance Surgical Gown, is substantially equivalent to the predicate gown including meeting the requirements of AAMI Level 4 liquid barrier requirements. |
| Summary of | |
| Testing: | The Kimberly-Clark* MicroCool* Breathable High Performance Surgical Gown, has been tested in compliance with the requirements of Level 4 liquid barrier performance requirements of ANSI/AAMI PB70: 2003 "Liquid barrier performance and classification of protective apparel and drapes intended for use in health care facilities." The MicroCool* Breathable High Performance Surgical Gown also meets the requirements of ASTM1671:2003 Standard test method for resistance of materials used in protective clothing to penetration by blood-borne pathogens using Phi-X174 bacteriophage penetration as a test system. The MicroCool* Breathable High Performance Surgical Gown meets the requirements of Flame Resistant CPSC 1610 Class 1. The MicroCool* Breathable High Performance Surgical Gown has also been tested in compliance with the biocompatibility requirements of ISO 10993 for surface devices with limited contact with breached or compromised surfaces. All results of testing met acceptance criteria. |
| Conclusion: | The performance testing submitted for the MicroCool* Breathable High Performance Surgical Gown demonstrates substantial equivalence to the predicate KIMBERLY-CLARK* MICROCOOL SURGICAL GOWN, BREATHABLE HIGH PERFORMANCE, KC400 (K091357) in intended use, design, materials, performance, and biocompatibility attributes. |
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird-like symbol with three curved lines representing its wings or body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the symbol. The logo is black and white and appears to be a scanned or printed image.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MID 20993-0002
Kimberly-Clark Corporation C/O Mr. Ned Devine Responsible Third Party Official Underwriters Laboratories. Incorporated 333 Pfingsten Road Northbrook, Illinois 60062
DEC 2 3 2010
Re: K103406
Trade/Device Name: MicroCool*Breathable High Performance, Surgical Gowns Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical Apparel Regulatory Class: II Product Code: FYA Dated: December 15, 2010 Received: December 15, 2010
Dear Mr. Devine:
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.
3
Page 2 – Mr. Devine
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 go to
http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Anthony Watson, B.S., M.S., M.B.A. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
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Indications for Use
510(k) Number (if known): K103406
Device Name: MicroCool* Breathable High Performance, Surgical Gowns
Indications for Use:
The Kimberly-Clark* MicroCool* 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 MicroCool* Surgical Gown meets the Level 4 requirements of the AAMI Liquid Barrier classifications.
The Kimberly-Clark* MicroCool* Surgical Gowns are also sold as bulk non-sterile, single use items, to repackager/relabeler establishments for further packaging and Ethylene Oxide (EtO) sterilization.
Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use × (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Elizabeth F. Laurie-Miller
(Division Sign-Off)
Division of Anesthesiology, General Hospital
Infection Control and Dental Devices
510(k) Number: K 103 406
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Addendum
The MicroCool* Surgical Gowns are available under the following Reference Numbers and descriptions.
| New Product
| OASIS Code | Product Description |
|---|---|
| Sterile Codes | |
| 92038 | MicroCool* Breathable High Performance, Surgical Gown Large, X-Long |
| 92042 | MicroCool* Breathable High Performance, Surgical Gown, X-Large, X-Long |
| 92320 | MicroCool* Breathable High Performance, Surgical Gown, Large, with Secure-Fit |
| 92321 | MicroCool* Breathable High Performance, Surgical Gown, X-Large, with Secure-Fit |
| 92323 | MicroCool* Breathable High Performance, Surgical Gown, XX-Large, with Secure-Fit |
| 92330 | MicroCool* Breathable High Performance, Surgical Gown, Large, Specialty, with Secure-Fit |
| 92331 | MicroCool* Breathable High Performance, Surgical Gown, X-Large, Specialty, with Secure-Fit |
| 92333 | MicroCool* Breathable High Performance, Surgical Gown, XX-Large, Specialty, with Secure-Fit |
| 92336 | MicroCool* Breathable High Performance, Surgical Gown, Small |
| 92338 | MicroCool* Breathable High Performance, Surgical Gown, Small, with Secure-Fit |
| 92340 | MicroCool* Breathable High Performance, Surgical Gown, Large |
| 92342 | MicroCool* Breathable High Performance, Surgical Gown, X-Large |
| 92344 | MicroCool* Breathable High Performance, Surgical Gown, XX-Large |
| 92351 | MicroCool* Breathable High Performance, Surgical Gown, Large, Specialty |
| 92353 | MicroCool* Breathable High Performance, Surgical Gown, X-Large, Specialty |
| 92354 | MicroCool* Breathable High Performance, Surgical Gown, Large, with Secure-Fit |
| 92355 | MicroCool* Breathable High Performance, Surgical Gown, X-Large, with Secure-Fit, |
| 92357 | MicroCool* Breathable High Performance, Surgical Gown, XX-Large, Specialty |
| 92358 | MicroCool* Breathable High Performance, Surgical Gown, XX-Large, with Secure-Fit |
| 10558 | MicroCool* Breathable High Performance, Surgical Gown, Large, Specialty, with Secure-Fit |
| 10550 | MicroCool* Breathable High Performance, Surgical Gown, X-Large, Specialty, with Secure-Fit |
| 10566 | MicroCool* Breathable High Performance, Surgical Gown, XX-Large, Specialty, with Secure-Fit |
| 92347 | MicroCool* Breathable High Performance, Surgical Gown, XXX-Large, with Secure-Fit |
| 13359 | MicroCool* Breathable High Performance, Surgical Gown, Small, with Secure-Fit |
| Non-sterile Codes | |
| 72438 | MicroCool* Breathable High Performance, Surgical Gown, Large |
| 72445 | MicroCool* Breathable High Performance, Surgical Gown, X-Large |
| 72447 | MicroCool* Breathable High Performance, Surgical Gown, XX-Large |
| 72448 | MicroCool* Breathable High Performance, Surgical Gown, XX-Large, with Secure-Fit, |
| 72451 | MicroCool* Breathable High Performance, Surgical Gown, Large, Specialty |
| 72453 | MicroCool* Breathable High Performance, Surgical Gown, X-Large, Specialty |
| 72454 | MicroCool* Breathable High Performance, Surgical Gown, Large, with Secure-Fit |
| 72455 | MicroCool* Breathable High Performance, Surgical Gown, X-Large, with Secure-Fit |
| 72457 | MicroCool* Breathable High Performance, Surgical Gown, XX-Large, Specialty |
| 73038 | MicroCool* Breathable High Performance, Surgical Gown, Large, X-Long |
| 73041 | MicroCool* Breathable High Performance, Surgical Gown, X-Large, X-Long |
| 79729 | MicroCool* Breathable High Performance, Surgical Gown, Large |
| 79739 | MicroCool* Breathable High Performance, Surgical Gown, X-Large |