(209 days)
The Kimberly-Clark Procedure Gown is a non-sterile, disposable, single use item of apparel intended to be worn by healthcare professionals during the preparation and administration of selected chemotherapy drugs. The gown is not intended to be worn during surgical procedures.
The Kimberly-Clark Comfort Gown is an open back gown manufactured from a non-woven fabric with a film laminate coating. The non-woven fabric is a polypropylene spunbond with a polyethylene coating. The composition of the gown fabric resists tearing and permeation by various chemotherapy drugs for up to four hours of use.
The provided text describes a 510(k) premarket notification for the Kimberly-Clark Procedure Gown, a non-sterile, disposable gown intended for use by healthcare professionals during the preparation and administration of selected chemotherapy drugs. The submission demonstrates substantial equivalence to a predicate device, the Kimberly-Clark Impervious Open Back Gown (K880382).
The core of this submission is demonstrating that the new device meets specific performance criteria through testing.
1. Table of Acceptance Criteria and Reported Device Performance
| Test | Acceptance Criteria (Implied by meeting standard) | Reported Device Performance |
|---|---|---|
| Dermal Irritation & Sensitization | No evidence of dermal irritation or allergic contact sensitization (as expected for patient contact devices) | No evidence of dermal irritation or allergic contact sensitization |
| Flammability | Meets Class I flammability requirements per NFPA Standard #702-1980 | Meets Class I flammability requirements per NFPA Standard #702-1980 |
| Liquid Chemical Permeation | No permeation of specified chemotherapy drugs for up to 240 minutes (4 hours) per ASTM F 739-99a | Results showed no permeation of the specified chemotherapy drugs (carmustine, cisplatin, cyclophosphamide, dacarbazine, doxorubicin hydrochloride, etoposide, fluorouracil, paclitaxel, thioTEPA and vincristine sulfate) for up to 240 minutes. |
| Fluid Penetration | "Pass" determination based on visual detection of synthetic blood penetration per ASTM-F 1670-03 | Resistance of the gown fabric to penetration by blood under conditions of continuous liquid contact; "pass" determination based on visual detection of synthetic blood penetration. |
| Viral Penetration | "Pass" determination based on detection of viral penetration per ASTM-F 1671-03 | Resistance of the gown fabric to penetration by blood-borne pathogens under conditions of continuous liquid contact; "pass" determination based on detection of viral penetration. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the specific sample sizes used for each test (e.g., how many gown samples were tested for permeation, flammability, etc.). It refers to industry standards (e.g., ASTM, NFPA), which would have their own defined sample size requirements for each test method.
The data provenance is retrospective, as the tests were conducted on the Kimberly-Clark Procedure Gown to demonstrate its characteristics. The country of origin for the data is implicitly the United States, as the submission is to the U.S. FDA and references U.S. standards (ASTM, NFPA).
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
This information is not applicable in this context. This is a premarket notification for a physical medical device (a gown), not an AI/software device that requires expert review for ground truth establishment. The performance is assessed through standardized physical and chemical tests rather than expert interpretation.
4. Adjudication Method for the Test Set
This information is not applicable. Adjudication methods (like 2+1, 3+1) are typically used in clinical studies or studies involving human readers/interpreters to resolve discrepancies in diagnoses or assessments. For physical device testing, the results are objectively determined by the test method (e.g., a permeation threshold, visual observation for penetration, or a flammability measurement).
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is relevant for AI-powered diagnostic tools where human readers (e.g., radiologists) interpret images with and without AI assistance. The Kimberly-Clark Procedure Gown is a physical barrier device, and its effectiveness is determined by its physical and chemical properties, not by human interpretation of data.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
This question is not applicable. This device is a physical medical device. The concept of "standalone algorithm performance" refers to the performance of an AI algorithm without human involvement, which is not relevant to a medical gown.
7. The Type of Ground Truth Used
The "ground truth" for the performance of the Kimberly-Clark Procedure Gown is established by objective, standardized laboratory test results and their comparison against the defined acceptance criteria (e.g., "no permeation for up to 240 minutes," "meets Class I flammability"). These tests quantify the physical and chemical properties of the gown, such as its barrier performance against liquids, chemicals, and viruses, and its flammability.
8. The Sample Size for the Training Set
This question is not applicable. There is no "training set" in the context of a physical medical device like this gown. Training sets are used to develop and train AI algorithms. The performance of this gown is based on its material properties and manufacturing.
9. How the Ground Truth for the Training Set Was Established
This question is not applicable for the same reasons as #8. There is no training set for this device.
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Premarket Notification [510(k)] Summary
| 1. | Submitted by: | Kimberly-Clark Corporation1400 Holcomb Bridge RoadRoswell, GA 30076 | |
|---|---|---|---|
| Contact Person: | Cheryl M. SanzareAssociate Director Regulatory Affairs | ||
| Telephone:Facsimile:e-mail: | (770) 587-7131(920) 380-6308cheryl.sanzare@kcc.com |
April 26, 2006 Date Prepared:
2. Device Name
Trade / Proprietary Name: Kimberly-Clark Procedure Gown Common / Usual name: Surqical gown Gown, surgical (per 21CFR 878.4040) Classification Name:
3. Predicate Device
Kimberly-Clark Procedure Gown is substantially equivalent to the The Kimberly-Clark Impervious Open Back Gown cleared under K880382.
4. Intended Use of the Device
The Kimberly-Clark Procedure Gown is a non-sterile, disposable, single use item of apparel intended to be worn by healthcare professionals during the preparation and administration of selected chemotherapy drugs. The gown is not intended to be worn during surgical procedures.
5. Description of the Device
The Kimberly-Clark Comfort Gown is an open back gown manufactured from a non-woven fabric with a film laminate coating. The non-woven fabric is a polypropylene spunbond with a polyethylene coating. The composition of the gown fabric resists tearing and permeation by various chemotherapy drugs for up to four hours of use.
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Premarket Notification [510(k)] Summary (Continued)
Summary of the technological characteristics of the device compared to 6. the predicate device
The Kimberly-Clark Procedure Gown and the Kimberly-Clark Impervious Open Back Gown (K880382) are manufactured with similar materials of construction. Neither gown is intended to be worn during surgical procedures as both gowns are provided as non-sterile. The K-C Procedure Gown is substantially equivalent to the K-C Imperious Open Back Gown in that they both provide the following characteristics: good tear resistance and fluid barrier.
| Summary of Testing: | |
|---|---|
| Test | Result |
| Dermal Irritation & Sensitization | No evidence of dermal irritationor allergic contact sensitization |
| Flammability | Meets Class I flammabilityrequirements per NFPA Standard#702-1980. |
| Liquid Chemical Permeation | Permeation testing per ASTM F 739-99a with the following chemotherapydrugs: carmustine, cisplatin,cyclophosphamide, dacarbazine,doxorubicin hydrochloride,etoposide, fluorouracil, paclitaxel,thioTEPA and vincristine sulfate.Results showed no permeation ofthe drugs for up to 240 minutes. |
| Fluid Penetration | Penetration testing per ASTM-F1670-03 with resistance of the gownfabric to penetration by blood underconditions of continuous liquidcontact. The 'pass' determinationwas based on visual detection ofsynthetic blood penetration. |
| Viral Penetration | Penetration testing per ASTM-F 1671-03 with resistance of the gown fabric topenetration by blood-borne pathogensunder conditions of continuous liquidcontact. The 'pass' determination wasbased on detection of viral penetration. |
Section of the courses
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three lines forming its body and wings. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES. USA" is arranged in a circular pattern around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY 2 2006
Ms. Cheryl M. Sanzare Associate Director Regulatory Affairs Kimberly-Clark Corporation 1400 Holcomb Bridge Road Roswell, Georgia 30076
Re: K052824
Trade/Device Name: Kimberly-Clark Procedure Gown Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical Apparel Regulatory Class: II Product Code: FYA Dated: April 10, 2006 Received: April 11, 2006
Dear Ms. Sanzare:
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.
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Page 2 - Ms. Sanzare
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 Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours.
Chiu-Ling, Ph.D.
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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Indications For Use
| Applicant: | Kimberly-Clark Corporation |
|---|---|
| 510(k) Number: | K052824 |
| Device Name: | Kimberly-Clark Procedure Gown |
| Indications for Use: | Based upon 21CFR§878.4040; Surgical apparel |
| The Kimberly-Clark Procedure Gown is a non-sterile,disposable, single use item of apparel intended to beworn by healthcare professionals during thepreparation and administration of selectedchemotherapy drugs. The gown is not intended to beworn during surgical procedures. |
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ONANOTHER PAGE IF NEEDED)
Concurrence of CDRH Office of Device Evaluation (ODE)
| Prescription Use |
|---|
| ------------------ |
Over-the-Counter
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Shuli Hughes 5/1/66
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K 052824
Station and the control of the country
§ 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.