(43 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:
The following drugs had NO breakthrough detected up to 240 minutes:
Bleomycin sulfate (15.0mg/ml), Gemcitabine (38.0mg/ml), Busulfan (6.0mg/ml), Idarubicin (1.0mg/ml), Carboplatin (10.0mg/ml), Ifosfamide (50mg/ml), Cisplatin (1 mg/ml), Irinotecan (20.0mg/ml), Cyclophosphamide (20 mg/ml), Mechlorethamine HCl (1.0mg/ml), Cytarabine HCl (100.0mg/ml), Melphalan (5.0mg/ml), Dacarbazine (10 mg/ml), Methotrexate (25.0mg/ml), Daunorubicin Hcl (5.0mg/ml), Mitomycin (0.5mg/ml), Docetaxel (10.0mg/ml), Mitoxantrone (2 mg/ml), Doxorubicin HCl (Adriamycin) (2 mg/ml), Paclitaxel (Taxol) (6 mg/ml), Ellence (Epirubicin) (2.0mg/ml), Paraplatin (10.0mg/ml), Etoposide (20 mg/ml), Rituximab (10.0mg/ml), Fludarabine (25.0mg/ml), Trisenox (0.1mg/ml), Fluorouracil (adrucil) (50 mg/ml), Vincrinstine Sulfate (1 mg/ml)
The following drugs showed breakthrough detected in less than 30 minutes:
Carmustine (3.3mg/ml): 1.8 minutes, ThioTEPA (10.0mg/ml): 1.7 minutes
Warning - Not for Use with Carmustine and ThioTEPA
Kimberly-Clark PURPLE NITRILE-XTRA* Powder-Free Exam Gloves (Chemotherapy Glove) are 12inch long, non-sterile purple-colored nitrile, powder-free, ambidextrous patient examination glove that meets all of the requirements of ASTM D6319-00a, 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."
Kimberly-Clark PURPLE NITRILE* Powder-Free Exam Gloves (Chemotherapy Glove) are 9.5-inch long, non-sterile purple-colored nitrile, powder-free, ambidextrous patient examination glove that meets all of the requirements of ASTM D6319-00a, 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."
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 all of the requirements of ASTM D6319-00a, Standard Specification for Nitrile Examination Gloves for Medical Application.
Kimberly-Clark PURPLE NITRILE-XTRA* Powder-Free Exam Gloves are 12-inch long, non-sterile purple-colored nitrile, powder-free, ambidextrous patient examination glove that meets all of the requirements of ASTM D6319-00a, Standard Specification for Nitrile Examination Gloves for Medical Application.
Here's a breakdown of the acceptance criteria and study information for the Kimberly-Clark PURPLE NITRILE-XTRA* Powder-Free Exam Gloves (Chemotherapy), based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The device (Kimberly-Clark PURPLE NITRILE-XTRA* Powder-Free Exam Gloves) is tested against several FDA-recognized consensus standards. The performance results consistently indicate that the device "Meets ASTM Requirements" or has "NO breakthrough detected" for most chemotherapy drugs up to 240 minutes.
| Characteristics / Acceptance Criteria (Standard) | Reported Device Performance (Result) |
|---|---|
| General Glove Requirements | |
| Dimensions (ASTM D6319-00a) | Meets ASTM Requirements |
| Physical Properties (ASTM D6319-00a) | Meets ASTM Requirements |
| Freedom from pinholes (ASTM D6319-00a, D5151-06) | Meets ASTM Requirements |
| Powder Free (Powder Content) (ASTM D6319-00a, D6124-06) | Meets ASTM Requirements |
| Biocompatibility | |
| ISO Skin Irritation Study and Sensitization (ISO 10993, Part 10) | Meets ASTM Requirements |
| ISO Cytotoxicity Study (ISO 10993, Part 5) | Meets ASTM Requirements |
| Chemotherapy Permeation Resistance (ASTM D6978-05 and/or ASTM F739-07) | Meets ASTM Requirements |
| Bleomycin sulfate (15.0mg/ml) | NO breakthrough detected up to 240 minutes |
| Busulfan (6.0mg/ml) | NO breakthrough detected up to 240 minutes |
| Carboplatin (10.0mg/ml) | NO breakthrough detected up to 240 minutes |
| Cisplatin (1 mg/ml) | NO breakthrough detected up to 240 minutes |
| Cyclophosphamide (20 mg/ml) | NO breakthrough detected up to 240 minutes |
| Cytarabine HCl (100.0mg/ml) | NO breakthrough detected up to 240 minutes |
| Dacarbazine (10 mg/ml) | NO breakthrough detected up to 240 minutes |
| Daunorubicin Hcl (5.0mg/ml) | NO breakthrough detected up to 240 minutes |
| Docetaxel (10.0mg/ml) | NO breakthrough detected up to 240 minutes |
| Doxorubicin HCI (Adriamycin) (2 mg/ml) | NO breakthrough detected up to 240 minutes |
| Ellence (Epirubicin) (2.0mg/ml) | NO breakthrough detected up to 240 minutes |
| Etoposide (20 mg/ml) | NO breakthrough detected up to 240 minutes |
| Fludarabine (25.0mg/ml) | NO breakthrough detected up to 240 minutes |
| Fluorouracil (adrucil) (50 mg/ml) | NO breakthrough detected up to 240 minutes |
| Gemcitabine (38.0mg/ml) | NO breakthrough detected up to 240 minutes |
| Idarubicin (1.0mg/ml) | NO breakthrough detected up to 240 minutes |
| Ifosfamide (50mg/ml) | NO breakthrough detected up to 240 minutes |
| Irinotecan (20.0mg/ml) | NO breakthrough detected up to 240 minutes |
| Mechlorethamine HCl (1.0mg/ml) | NO breakthrough detected up to 240 minutes |
| Melphalan (5.0mg/ml) | NO breakthrough detected up to 240 minutes |
| Methotrexate (25.0mg/ml) | NO breakthrough detected up to 240 minutes |
| Mitomycin (0.5mg/ml) | NO breakthrough detected up to 240 minutes |
| Mitoxantrone (2 mg/ml) | NO breakthrough detected up to 240 minutes |
| Paclitaxel (Taxol) (6 mg/ml) | NO breakthrough detected up to 240 minutes |
| Paraplatin (10.0mg/ml) | NO breakthrough detected up to 240 minutes |
| Rituximab (10.0mg/ml) | NO breakthrough detected up to 240 minutes |
| Trisenox (0.1mg/ml) | NO breakthrough detected up to 240 minutes |
| Vincrinstine Sulfate (1 mg/ml) | NO breakthrough detected up to 240 minutes |
| Carmustine (3.3mg/ml) | Breakthrough detected in 1.8 minutes (Warning: Not for Use) |
| ThioTEPA (10.0mg/ml) | Breakthrough detected in 1.7 minutes (Warning: Not for Use) |
2. Sample Size Used for the Test Set and Data Provenance
The provided document does not explicitly state the specific sample sizes for tests such as dimensions, physical properties, pinholes, or powder content. However, the testing for resistance to permeation by chemotherapy drugs was performed per ASTM D6978-05 (and/or ASTM F739-07), which would specify the required sample sizes and methodology for these tests. The data provenance is retrospective, as the tests were conducted by the manufacturer, Kimberly-Clark, to demonstrate substantial equivalence to previously marketed devices. The country of origin of the data is not specified beyond being generated by the applicant (Kimberly-Clark Corporation, Roswell, GA), implying it was likely conducted in the United States or at a facility capable of performing ASTM standards.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not applicable in this context. The "ground truth" for glove performance (like physical properties, pinholes, or chemical permeation) is established by adhering to widely accepted, standardized laboratory testing procedures outlined in the ASTM and ISO standards (e.g., ASTM D6319-00a, ASTM D5151-06, ASTM D6124-06, ISO 10993 Parts 5 & 10, ASTM D6978-05, ASTM F739-07). These tests do not require human expert consensus for interpreting results, but rather rely on instrumental measurements and defined pass/fail criteria within the standards.
4. Adjudication Method for the Test Set
This is not applicable. As mentioned above, the performance is determined by meeting the objective criteria of the specified ASTM and ISO standards, not through expert adjudication in the traditional sense (e.g., 2+1 radiologist review).
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
This is not applicable. This submission is for a medical device (exam gloves), not an AI-powered diagnostic or assistive tool. Therefore, MRMC studies and AI assistance are not relevant.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
This is not applicable. This device is not an algorithm or AI system.
7. The Type of Ground Truth Used
The ground truth used for product evaluation is based on objective measurements and predefined criteria specified within recognized consensus standards (ASTM and ISO standards). For example, for chemical permeation, the ground truth is whether "breakthrough" occurred within a specified timeframe, as measured by precise analytical methods according to ASTM D6978-05. For physical properties, it's defined by measurements falling within the ranges stipulated by ASTM D6319-00a.
8. The Sample Size for the Training Set
This is not applicable. This is a physical medical device, not a machine learning model. There is no "training set" in the context of this regulatory submission.
9. How the Ground Truth for the Training Set was Established
This is not applicable, as there is no training set for this device.
§ 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.