(209 days)
Not Found
No
The device is a procedure gown made of non-woven fabric with a film laminate coating, designed for protection against chemotherapy drugs. There is no mention of any computational or analytical capabilities, let alone AI/ML.
No
This device is a protective gown for healthcare professionals when handling chemotherapy drugs, not a device used to treat a disease or condition.
No
The document describes a protective gown used by healthcare professionals when handling chemotherapy drugs. Its purpose is to protect the wearer, not to diagnose medical conditions or provide diagnostic information.
No
The device description clearly states it is a physical gown made of non-woven fabric with a film laminate coating, indicating it is a hardware device, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the gown is for healthcare professionals to wear during the preparation and administration of chemotherapy drugs. This is a protective barrier function, not a diagnostic test performed on samples taken from the body.
- Device Description: The description details the physical properties of the gown (fabric, coating, resistance to tearing and permeation). This aligns with a protective garment, not a diagnostic device.
- Performance Studies: The performance studies focus on the gown's protective qualities (dermal irritation, flammability, resistance to chemical and fluid penetration). These are relevant to a barrier device, not an IVD.
IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for the diagnosis, monitoring, or treatment of diseases or conditions. This gown does not perform any such function.
N/A
Intended Use / Indications for Use
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.
Product codes (comma separated list FDA assigned to the subject device)
FYA
Device Description
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.
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
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Test: Dermal Irritation & Sensitization. Result: No evidence of dermal irritation or allergic contact sensitization.
Test: Flammability. Result: Meets Class I flammability requirements per NFPA Standard #702-1980.
Test: Liquid Chemical Permeation. Result: Permeation testing per ASTM F 739-99a with the following chemotherapy drugs: carmustine, cisplatin, cyclophosphamide, dacarbazine, doxorubicin hydrochloride, etoposide, fluorouracil, paclitaxel, thioTEPA and vincristine sulfate. Results showed no permeation of the drugs for up to 240 minutes.
Test: Fluid Penetration. Result: Penetration testing per ASTM-F 1670-03 with resistance of the gown fabric to penetration by blood under conditions of continuous liquid contact. The 'pass' determination was based on visual detection of synthetic blood penetration.
Test: Viral Penetration. Result: Penetration testing per ASTM-F 1671-03 with resistance of the gown fabric to penetration by blood-borne pathogens under conditions of continuous liquid contact. The 'pass' determination was based on detection of viral penetration.
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
Premarket Notification [510(k)] Summary
| 1. | Submitted by: | Kimberly-Clark Corporation
1400 Holcomb Bridge Road
Roswell, GA 30076 | |
|----|-------------------------------------|-----------------------------------------------------------------------------|--|
| | Contact Person: | Cheryl M. Sanzare
Associate Director Regulatory Affairs | |
| | Telephone:
Facsimile:
e-mail: | (770) 587-7131
(920) 380-6308
cheryl.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.
1
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 irritation |
| or allergic contact sensitization | |
| Flammability | Meets Class I flammability |
| requirements per NFPA Standard | |
| #702-1980. | |
| Liquid Chemical Permeation | Permeation testing per ASTM F 739- |
| 99a with the following chemotherapy | |
| drugs: carmustine, cisplatin, | |
| cyclophosphamide, dacarbazine, | |
| doxorubicin hydrochloride, | |
| etoposide, fluorouracil, paclitaxel, | |
| thioTEPA and vincristine sulfate. | |
| Results showed no permeation of | |
| the drugs for up to 240 minutes. | |
| Fluid Penetration | Penetration testing per ASTM-F |
| 1670-03 with resistance of the gown | |
| fabric to penetration by blood under | |
| conditions of continuous liquid | |
| contact. The 'pass' determination | |
| was based on visual detection of | |
| synthetic blood penetration. | |
| Viral Penetration | Penetration testing per ASTM-F 1671- |
| 03 with resistance of the gown fabric to | |
| penetration by blood-borne pathogens | |
| under conditions of continuous liquid | |
| contact. The 'pass' determination was | |
| based on detection of viral penetration. |
Section of the courses
2
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.
3
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
4
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 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. |
(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
ズ
Shuli Hughes 5/1/66
Or
Ance II.aelology, General Hospill : Control. Dental Devices
K 052824
Station and the control of the country