(167 days)
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No
The summary describes a physical surgical gown and its barrier performance, with no mention of AI or ML technology.
No
The device protects against the transfer of microorganisms, body fluids, and particulate material, preventing harm rather than treating an existing condition.
No
The device description clearly states it is a surgical gown, intended to protect from transfer of microorganisms and fluids, not to diagnose medical conditions.
No
The device description clearly indicates it is a physical surgical gown made of nonwoven SMS polypropylene, not a software product.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to detect diseases, conditions, or infections. These tests are performed outside of the body.
- Device Description and Intended Use: The description clearly states the device is a surgical gown intended to protect patients and personnel from the transfer of microorganisms, body fluids, and particulate material during surgery. This is a barrier device used on the body or in the surgical environment, not for testing samples.
- Lack of IVD Characteristics: The document does not mention any testing of biological samples, analysis of biomarkers, or diagnostic purposes.
Therefore, based on the provided information, the Kimberly-Clark ULTRA Surgical Gown and ULTRA Film-Reinforced Surgical Gown are not IVDs. They are classified as medical devices, specifically protective apparel.
N/A
Intended Use / Indications for Use
The Kimberly-Clark* ULTRA Surgical Gown and ULTRA Film-Reinforced Surgical Gown are sterile, single use surgical gowns intended to protect surgical patients and operating room personnel from the transfer of microorganisms, body fluids, and particulate material. The ULTRA Surgical Gown meets Level 3 of the AAMI Liquid Barrier classifications, and the ULTRA Film-Reinforced Surgical Gown meets Level 4 of the AAMI Liquid Barrier classifications.
Product codes
FYA
Device Description
The ULTRA Surgical Gown and ULTRA Film-Reinforced Surgical Gown are full-length, nonwoven SMS polypropylene gowns. They are constructed with raglan sleeves, hook-and-loop neck closures, and tie waist closures. The ULTRA Film-Reinforced Surgical Gown is film-reinforced for higher barrier protection. The ULTRA Surgical Gown fully meets the Association for the Advancement of Medical Instrumentation (AAMI) Level 3 requirements for liquid barrier performance. The ULTRA Film-Reinforced Surgical Gown fully meets the AAMI Level 4 requirements for liquid barrier performance.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
surgical patients and operating room personnel
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies
The ULTRA Surgical Gown has been tested in compliance with the requirements of Level 3 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 ULTRA Film-Reinforced Surgical Gown has been tested in compliance with the requirements of Level 4 liquid barrier performance requirements of ANSI/AAMI PB70: 2003. The ULTRA Surgical Gown and ULTRA Film-Reinforced Surgical Gown also meet the requirements of the National Fire Protection Association (NFPA) Test Method 702-1980 for Class I. The ULTRA Surgical Gown and ULTRA Film-Reinforced Surgical Gown have been tested in compliance with the biocompatibility requirements of ISO 10993 for surface devices with limited contact with breached or compromised surfaces.
Key Metrics
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Predicate Device(s)
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Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 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
Kimberly-Clark* Corporation Abbreviated 510(k) for the ULTRA Surgical Gown and ULTRA Film-Reinforced Surgical Gown
510(k) Summary for the ULTRA Surgical Gown and ULTRA Film-Reinforced Surgical Gown
SEP - 3 2008
Intended Use: The Kimberly-Clark" ULTRA Surgical Gown and ULTRA Film-Reinforced Surgical Gown are sterile, single use surgical gowns intended to protect surgical patients and operating room personnel from the transfer of microorganisms, body fluids, and particulate material. The ULTRA Surgical Gown meets Level 3 of the AAMI Liquid Barrier classifications, and the ULTRA Film-Reinforced Surgical Gown meets Level 4 of the AAMI Liquid Barrier classifications.
Device Description: The ULTRA Surgical Gown and ULTRA Film-Reinforced Surgical Gown are full-length, nonwoven SMS polypropylene gowns. They are constructed with raglan sleeves, hook-and-loop neck closures, and tie waist closures. The ULTRA Film-Reinforced Surgical Gown is film-reinforced for higher barrier protection. The ULTRA Surgical Gown fully meets the Association for the Advancement of Medical Instrumentation (AAMI) Level 3 requirements for liquid barrier performance. The ULTRA Film-Reinforced Surgical Gown fully meets the AAMI Level 4 requirements for liquid barrier performance.
Substantial Equivalence: The ULTRA Surgical Gown and ULTRA Film-Reinforced Surgical Gown are substantially equivalent to the predicate Kimberly-Clark KIMGUARD* and SPUNGUARD* Surgical Gowns in intended use, design, materials, and biocompatibility attributes. The performance attributes of the ULTRA gowns are substantially equivalent to the predicate gowns with the exception that the ULTRA Surgical Gown meets the requirements of AAMI Level 3 liquid barrier requirements and the ULTRA Film-Reinforced Surgical Gown meets the requirements of AAMI Level 4 liquid barrier requirements. The ULTRA gowns and their predicates are provided sterile and for single use.
Summary of Testing: The ULTRA Surgical Gown has been tested in compliance with the requirements of Level 3 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 ULTRA Film-Reinforced Surgical Gown has been tested in compliance with the requirements of Level 4 liquid barrier performance requirements of ANSI/AAMI PB70: 2003. The ULTRA Surgical Gown and ULTRA Film-Reinforced Surgical Gown also meet the requirements of the National Fire Protection Association (NFPA) Test Method 702-1980 for Class I. The ULTRA Surgical Gown and ULTRA Film-Reinforced Surgical Gown have been tested in compliance with the biocompatibility requirements of ISO 10993 for surface devices with limited contact with breached or compromised surfaces.
- Registered Trademark or Trademark of Kimberly-Clark Worldwide, Inc. or its affiliates.
1
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/1/Picture/12 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with its wings spread, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular fashion around the eagle. The eagle is depicted in black, and the text is also in black against a white background. The logo is simple and recognizable, representing the department's role in providing health and human services to the nation.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SEP - 8 2008
Mr. David M. Lee Associate Director of Regulatory Affairs Kimberly-Clark Corporation 1400 Holcomb Bridge Road Roswell, Georgia 30076
Re: K080795
Trade/Device Name: Ultra Surgical Gown Ultra Film-Reinforced Surgical Gown Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical Apparel Regulatory Class: II Product Code: FYA Dated: August 15, 2008 Received: August 19, 2008
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 such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements
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); 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. This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely vours.
T.K. Samueli-Leve, m.D. focll
Chiu Lin, Ph.D. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Page 1 of 2
Indications for Use
510(k) Number (if known): K080795
Device Name: _ULTRA Surgical Gowns and ULTRA Film-Reinforced Surgical Gowns
Indications for Use:
The Kimberly-Clark* ULTRA Surgical Gowns and ULTRA Film-Reinforced Surgical Gowns are sterile, single use surgical gowns intended to protect surgical patients and operating room personnel from the transfer of microorganisms, body fluids, and particulate material. The ULTRA Surgical Gowns meet Level 3 of the AAMI Liquid Barrier classifications, and the ULTRA Film-Reinforced Surgical Gowns meet Level 4 of the AAMI Liquid Barrier classications.
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)
Shala H Murphy 18
(Division Sign-Off)
Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number: K080795
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Addendum:
The ULTRA Surgical Gowns AAMI Level 3 are available under the following Reference Numbers:
- 95101 ULTRA Surgical Gown, Small
- 트 95111 ULTRA Surgical Gown, Large
- . 95121 ULTRA Surgical Gown, X-Large
- 95055 ULTRA Surgical Gown, Large (2 Pack) 파
- 미 95131 ULTRA Surgical Gown, XX-Large
The ULTRA Film-Reinforced Surgical Gowns AAMI Level 4 are available under the following Reference Numbers:
- 트 95411 ULTRA Film-Reinforced Surgical Gown, Large
- " 95421 ULTRA Film-Reinforced Surgical Gown, X-Large
- 95431 ULTRA Film-Reinforced Surgical Gown, XX-Large
- . 95511 ULTRA Film-Reinforced Specialty Surgical Gown, Large
- 트 95521 ULTRA Film-Reinforced Specialty Surgical Gown, X-Large
- I 95531 ULTRA Film-Reinforced Specialty Surgical Gown, XX-Large