(94 days)
Not Found
No
The device description and performance studies focus on the material properties and barrier performance of a surgical gown, with no mention of AI or ML technologies.
No
The document describes a surgical gown intended for protection against microorganisms and fluids, not for treating a medical condition.
No
The MicroCool Surgical Gown is sterile, single-use surgical apparel intended to protect both the patient and healthcare worker from the transfer of microorganisms, body fluids, and particulate matter. It is a protective barrier, not a diagnostic tool.
No
The device described is a surgical gown, which is a physical garment made of fabric. The description details the material composition and physical construction of the gown, with no mention of software components.
Based on the provided text, the device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the gown is "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 from the human body to provide information for diagnosis, monitoring, or treatment.
- Device Description: The description focuses on the materials and construction of a protective garment.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, reagents, calibrators, controls, or any other components typically associated with in vitro diagnostics.
Therefore, the Kimberly-Clark* MicroCool* Surgical Gown is a medical device, but it falls under the category of protective apparel, not in vitro diagnostics.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
FYA
Device Description
The MicroCool* Surgical Gown is manufactured from a breathable, repellent, non-woven, polypropylene fabric. The fabric is a threelayer lamination that resists tearing and penetration by liquids. The gown is constructed from a spunbond/film/spunbond design and is adhesively laminated. The spunbond layers are comprised of nonwoven polypropylene. The film layer is a multi-layer polypropylene olefin, breathable film. A 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 Spunbond facing lavers to the film layer to complete the composite. A new sleeve design was incorporated to meet Level 4 of the AAMI Liquid Barrier classifications.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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* Surgical Gown has been tested in compliance with the requirements of Level 4 liquid barrier performance of ANSI/AAMI PB70: 2003 "Liquid barrier performance and classification of protective apparel and drapes intended for use in health care facilities." The MicroCool* 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* Surgical Gown meets the requirements of Flame Resistant CPSC 1610 Class 1. The MicroCool* Surgical Gown has been tested in compliance with the biocompatibility requirements of ISO 10993 for surface devices with limited contact with breached or compromised surfaces.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
510(k) Summary for the Kimberly-Clark* MicroCool* Surgical Gowns. Breathable High Performance. KC400
Intended Use: The Kimberly-Clark* MicroCool* Surgical Gown, Breathable High Performance, KC 400 (hereinafter referred to as "MicroCool* Surgical Gown") 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 Gowns meet the Level 4 requirements of the AAMI PB70: 2003 Liquid Barrier classifications.
The 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.
Device Description The MicroCool* Surgical Gown is manufactured from a breathable, repellent, non-woven, polypropylene fabric. The fabric is a threelayer lamination that resists tearing and penetration by liquids. The gown is constructed from a spunbond/film/spunbond design and is adhesively laminated. The spunbond layers are comprised of nonwoven polypropylene. The film layer is a multi-layer polypropylene olefin, breathable film. A 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 Spunbond facing lavers to the film layer to complete the composite. A new sleeve design was incorporated to meet Level 4 of the AAMI Liquid Barrier classifications.
Substantial Equivalence: The MicroCool* Surgical Gown that is the subject of this 510(k) is substantially equivalent to the predicate Kimberly-Clark* MicroCool* Surgical Gown (K981393) in intended use, design, materials, and biocompatibility attributes. The performance attributes of the MicroCool* Surgical Gown are substantially equivalent to the predicate gown with the exception that this MicroCool* Surgical Gown meets the AAMI Level 4 liguid barrier requirement.
Summary of Testing: The Kimberly-Clark* MicroCool* Surgical Gown has been tested in compliance with the requirements of Level 4 liquid barrier performance of ANSI/AAMI PB70: 2003 "Liquid barrier performance and classification of protective apparel and drapes intended for use in health care facilities." The MicroCool* 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* Surgical Gown meets the requirements of Flame Resistant CPSC 1610 Class 1. The MicroCool* Surgical Gown has been tested in compliance with the biocompatibility requirements of ISO 10993 for surface devices with limited contact with breached or compromised surfaces. " Registered Trademark of Kimberly-Clark Worldwide. Inc. or its affiliates.
1
Image /page/1/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo features a stylized eagle with three lines representing its wings, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the eagle. The text is in all caps and is relatively small compared to the eagle symbol.
Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G609 Silver Spring, MD 20993-0002
Mr. David M. Lee Associate Director of Regulatory Affairs Kimberly-Clark Corporation 1400 Holcomb Bridge Road Building 300, #1092 Roswell, Georgia 30076
Re: K091357
Trade/Device Name: MicroCOOL* Surgical Gowns, Breathable High Performance, KC400
Regulation Number: 878.4040 Regulation Name: Surgical Apparel Regulatory Class: II Product Code: FYA Dated: July 14, 2009 Received: July 16, 2009
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.
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.
2
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 (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRH Offices/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.
Centron v. Wilson for
S. D. S. M.
Susan Runner, D.D.S., M.A. Acting Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
Indications for Use
510(k) Number (if known): __
Device Name: MicroCOOL* Surgical Gowns, Breathable High Performance, KC400
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)
Over-The-Counter Use AND/OR (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)
Shula H. Murphy, MD
Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
0(k)Number: K091357
Page 1 of 2 - Section 5. Indications for Use
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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* Surgical Gown, Breathable High Performance, KC400, Large, X-Long |
| 92042 | MicroCool* Surgical Gown, Breathable High Performance, KC400, X-Large, X-Long |
| 92320 | MicroCool* Surgical Gown, Breathable High Performance, KC400, Large, with Secure-Fit |
| 92321 | MicroCool* Surgical Gown, Breathable High Performance, KC400, X-Large, with Secure-Fit |
| 92323 | MicroCool* Surgical Gown, Breathable High Performance, KC400, XX-Large, with Secure-Fit |
| 92330 | MicroCool* Surgical Gown, Breathable High Performance, KC400, Large, Specialty, with Secure-Fit |
| 92331 | MicroCool* Surgical Gown, Breathable High Performance, KC400, X-Large, Specialty, with Secure-Fit |
| 92333 | MicroCool* Surgical Gown, Breathable High Performance, KC400, XX-Large, Specialty, with Secure-Fit |
| 92336 | MicroCool* Surgical Gown, Breathable High Performance, KC400, Small |
| 92338 | MicroCool* Surgical Gown, Breathable High Performance, KC400, Small, with Secure-Fit |
| 92340 | MicroCool* Surgical Gown, Breathable High Performance, KC400, Large |
| 92342 | MicroCool* Surgical Gown, Breathable High Performance, KC400, X-Large |
| 92344 | MicroCool* Surgical Gown, Breathable High Performance, KC400, XX-Large |
| 92351 | MicroCool* Surgical Gown, Breathable High Performance, KC400, Large, Specialty |
| 92353 | MicroCool* Surgical Gown, Breathable High Performance, KC400, X-Large, Specialty |
| 92354 | MicroCool* Surgical Gown, Breathable High Performance, KC400, Large, with Secure-Fit |
| 92355 | MicroCool* Surgical Gown, Breathable High Performance, KC400, X-Large, with Secure-Fit, |
| 92357 | MicroCool* Surgical Gown, Breathable High Performance, KC400, XX-Large, Specialty |
| 92358 | MicroCool* Surgical Gown, Breathable High Performance, KC400, XX-Large, with Secure-Fit |
| Non-sterile Codes | |
| 72438 | MicroCool* Surgical Gown, Breathable High Performance, KC400, Large |
| 72445 | MicroCool* Surgical Gown, Breathable High Performance, KC400, X-Large |
| 72447 | MicroCool* Surgical Gown, Breathable High Performance, KC400, XX-Large |
| 72448 | MicroCool* Surgical Gown, Breathable High Performance, KC400, XX-Large, with Secure-Fit, |
| 72451 | MicroCool* Surgical Gown, Breathable High Performance, KC400, Large, Specialty |
| 72453 | MicroCool* Surgical Gown, Breathable High Performance, KC400, X-Large, Specialty |
| 72454 | MicroCool* Surgical Gown, Breathable High Performance, KC400, Large, with Secure-Fit |
| 72455 | MicroCool* Surgical Gown, Breathable High Performance, KC400, X-Large, with Secure-Fit |
| 72457 | MicroCool* Surgical Gown, Breathable High Performance, KC400, XX-Large, Specialty |
| 73038 | MicroCool* Surgical Gown, Breathable High Performance, KC400, Large, X-Long |
| 73041 | MicroCool* Surgical Gown, Breathable High Performance, KC400, X-Large, X-Long |
| 79729 | MicroCool* Surgical Gown, Breathable High Performance, KC400, Large |
| 79739 | MicroCool* Surgical Gown, Breathable High Performance, KC400, X-Large |
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