(109 days)
A powder-free patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.
In addition, these chemotherapy gloves were tested for use with the following drug concentrations per ASTM D6978-05:
Bleomycin sulfate (15 mg/ml), Busulfan (6 mg/ml), Carboplatin (10 mg/ml), Cisplatin (1.0 mg/ml), Cyclophosphamide (20.0 mg/ml), Cytarabine HCl (100 mg/ml), Dacarbazine (10 mg/ml), Daunorubicin HCl (5.0 mg/ml), Docetaxel (10.0 mg/ml), Doxorubicin HCl (2.0 mg/ml), Epirubicin (Ellence) (2 mg/ml), Etoposide (20.0 mg/ml), Fludarabine (25 mg/ml), Fluorouracil (50.0 mg/ml), Gemcitabine HCl (38.0mg/ml), Idarubicin HCl (1.0mg/ml), Ifosfamide (50.0 mg/ml), Irinotecan HCl (20.0 mg/ml), Mechlorethamine HCl (1.0 mg/ml), Melphalan (5 mg/ml), Methotrexate (25 mg/ml), Mitomycin-C (0.5 mg/ml), Mitoxantrone (2.0 mg/ml), Paclitaxel (6.0 mg/ml), Rituximab (10 mg/ml), ThioTEPA (10.0 mg/ml), Trisenox (0.1 mg/ml), Vincristine Sulfate (1.0 mg/ml)
The following drugs had NO breakthrough detected up to 240 minutes:
Please note that the following drug has low permeation times of less than 60 minutes: Carmustine (3.3 mg/ml) 30.7 minutes
Kimberly-Clark PURPLE NITRILE* Powder-Free Exam Gloves are 9.5-inch long, non-sterile, purplecolored nitrile, powder-free, ambidextrous patient examination glove that meets the specifications of ASTM D 6319-10, Standard Specification for Nitrile Examination Gloves for Medical Application.
Kimberly-Clark PURPLE NITRILE-XTRA* Powder-Free Exam Gloves are 12-inch long, non-sterile, purplecolored nitrile, powder-free, ambidextrous patient examination glove that meets the specifications of ASTM D 6319-10, Standard Specification for Nitrile Examination Gloves for Medical Application.
Kimberly-Clark PURPLE NITRILE-XTRA* Powder-Free Exam Gloves are 12-inch long, non-sterile, purplecolored nitrile, powder-free, ambidextrous patient examination glove that meets the specifications of ASTM D 6319-10, Standard Specification for Nitrile Examination Gloves for Medical Application. In addition these gloves were tested for use with the drugs listed in the Intended Use(s) section below, per ASTM D6978-05 "Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs."
These gloves meet the 2008 Glove Guidance Manual recommended minimum thickness and length specifications for gloves tested for use with chemotherapy drugs.
The provided 510(k) summary (K113423) describes the non-clinical testing performed for Kimberly-Clark PURPLE NITRILE* Powder-Free Exam Gloves (9.5" Length), Kimberly-Clark PURPLE NITRILE-XTRA* Powder-Free Exam Gloves (12" Length), and Kimberly-Clark PURPLE NITRILE-XTRA* Powder-Free Exam Gloves (12") Tested for Use with Chemotherapy Drugs. As these are patient examination gloves, the evaluation focuses on their physical properties, safety, and, for one specific type, resistance to chemotherapy drugs, rather than AI/ML performance. Therefore, many of the requested categories related to AI/ML device studies (such as MRMC studies, human-in-the-loop performance, expert qualifications for ground truth, and training set information) are not applicable.
Here's an analysis of the acceptance criteria and study findings based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
| Characteristic | Acceptance Criteria (Applicable Standard) | Reported Device Performance |
|---|---|---|
| Dimensions | ASTM D 6319-10 (and 2008 FDA Glove Guidance Manual for length/thickness for chemo gloves) | Meets ASTM Requirements (and 2008 FDA Glove Guidance Manual for chemo gloves) |
| Physical Properties | ASTM D 6319-10 | Meets ASTM Requirements |
| Freedom from pinholes | ASTM D 6319-10, ASTM D 5151-06 | Meets ASTM Requirements |
| Powder Free (Powder Content) | ASTM D 6319-10, ASTM D 6124-06 | Meets ASTM Requirements |
| Skin Irritation Study & Sensitization | ISO 10993, Part 10 | Meets ASTM Requirements |
| Systemic Toxicity Study | ISO 10993, Part 11 | Meets ASTM Requirements |
| Resistance to Permeation (for chemo gloves only) | ASTM D 6978-05, ASTM F 739-07 | Meets ASTM Requirements (Specific drug permeation times provided) |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the sample sizes used for each specific test (e.g., number of gloves tested for dimensions, pinholes, etc.). It generally states that testing was conducted according to the referenced ASTM and ISO standards. These standards typically define sampling plans.
The data provenance is from non-clinical laboratory testing conducted by Kimberly-Clark Corporation, likely within the United States (as the applicant is based in Roswell, GA, and submitted to the U.S. FDA). The studies are prospective in the sense that the testing was performed specifically to evaluate the performance of these new glove models against established standards.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
Not applicable for this type of device. The "ground truth" for glove performance is established by the specified ASTM and ISO standards, which dictate methodologies and acceptable limits for physical and chemical properties. Human experts are involved in conducting these standardized tests and interpreting results against predefined criteria, but not in a "ground truth" sense as understood in AI/ML validation.
4. Adjudication Method for the Test Set
Not applicable. The performance is measured against objective, standardized laboratory test methods, not subjective human assessments requiring adjudication.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This device is a medical glove, not an AI/ML-powered diagnostic or assistive tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an AI/ML device.
7. The Type of Ground Truth Used
The "ground truth" for the performance of these gloves is defined by established consensus standards (ASTM D 6319-10, ASTM D 5151-06, ASTM D 6124-06, ISO 10993 Parts 10 & 11, ASTM D 6978-05, ASTM F 739-07, and the 2008 FDA Glove Guidance Manual). These standards specify the methods and acceptable performance limits for various physical, chemical, and biological properties of examination gloves. For the chemotherapy-tested gloves, the specific breakthrough times for various drugs further contribute to the performance "ground truth."
8. The Sample Size for the Training Set
Not applicable. There is no AI/ML model involved; therefore, no training set.
9. How the Ground Truth for the Training Set was Established
Not applicable, as there is no AI/ML model or training set.
§ 880.6250 Non-powdered patient examination glove.
(a)
Identification. A non-powdered patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner. A non-powdered patient examination glove does not incorporate powder for purposes other than manufacturing. The final finished glove includes only residual powder from manufacturing.(b)
Classification. Class I (general controls). The device, when it is a finger cot, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 880.9.