(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.
§ 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.