(167 days)
The glove is disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner. Gloves were tested for use with Chemotherapy drugs, Fentanyl and Gastric acid in accordance with ASTM D6978-05 standards Practice for assessment of Medical Glove to Permeation by chemotherapy drugs.
Nitrile Powder-Free Exam Gloves 2.8, Tested for Use with Chemotherapy Drugs, Opioid Fentanyl Citrate, Simulated Gastric Acid (light blue, dark blue)
The provided document is a 510(k) premarket notification approval letter for Nitrile Powder-Free Exam Gloves. It details the device's substantial equivalence to existing predicate devices and lists the results of permeation tests for various chemotherapy drugs, opioid fentanyl citrate, and simulated gastric acid.
However, the document does not describe a study involving an AI/software medical device requiring ground truth establishment, expert adjudication, or MRMC comparative effectiveness studies. The "acceptance criteria" discussed in this document relate to the gloves' resistance to permeation by specific chemicals, measured in "Minimum Breakthrough Detection Time."
Therefore, based solely on the provided text, it is not possible to answer the questions related to AI/software device performance, expert ground truth, adjudication methods, or MRMC studies.
Here's an attempt to answer the questions based on the information available in the document, acknowledging that most questions are not applicable to this type of device:
Acceptance Criteria and Device Performance for Nitrile Powder-Free Exam Gloves
The study presented here is a series of permeation tests conducted to determine the resistance of Nitrile Powder-Free Exam Gloves to various hazardous substances, specifically chemotherapy drugs, opioid fentanyl citrate, and simulated gastric acid. The acceptance criteria are implicit in the detailed breakthrough detection times, aiming to demonstrate the gloves' barrier properties against these substances. The tests were performed in accordance with ASTM D6978-05 standards.
1. Table of Acceptance Criteria and Reported Device Performance:
The document directly states the "Minimum Breakthrough Detection Time" for each substance for both the Light Blue and Dark Blue gloves. The implicit acceptance criterion would be that the gloves demonstrate a sufficiently long breakthrough time (ideally >240 minutes) for safe handling, or to clearly identify substances for which the gloves are not suitable. The reported performance is the actual measured breakthrough time.
Light Blue Glove Performance:
| Chemotherapy Drug / Substance | Minimum Breakthrough Detection Time (minutes) |
|---|---|
| Bendamustine HCl, 5 mg/ml | >240 min |
| Bortezomib (Velcade), 1 mg/ml | >240 min |
| Busulfan, 6 mg/ml | >240 min |
| Carboplatin, 10 mg/ml | >240 min |
| Carmustine, 3.3 mg/ml | 12.6 min. |
| Carfilzomib, 2 mg/ml | >240 min |
| Cetuximab (Erbitux), 2 mg/ml | >240 min |
| Chloroquine, 50mg/ml | >240 min |
| Cisplatin, 1 mg/ml | >240 min |
| Cladribine, 1.0 mg/ml | >240 min |
| Cyclophosphamide, 20 mg/ml | >240 min |
| Cyclosporin A,100mg/ml | >240 min |
| Cytarabine HCl, 100 mg/ml | >240 min |
| Cytovene, 10 mg/ml | >240 min |
| Dacarbazine, 10 mg/ml | >240 min |
| Daunorubicin HCl, 5 mg/ml | >240 min |
| Decitabine, 5 mg/ml | >240 min |
| Docetaxel, 10 mg/ml | >240 min |
| Doxorubicin HCl, 2 mg/ml | >240 min |
| Epirubicin HCl, 2 mg/ml | >240 min |
| Etoposide, 20 mg/ml | >240 min |
| Fludarabine Phosphate, 25 mg/ml | >240 min |
| 5-Fluorouracil, 50 mg/ml | >240 min |
| Gemcitabine HCl, 38 mg/ml | >240 min |
| Idarubicin HCl, 1 mg/ml | >240 min |
| Ifosfamide, 50 mg/ml | >240 min |
| Irinotecan HCl, 20 mg/ml | >240 min |
| Mechlorethamine HCl, 1 mg/ml | >240 min |
| Melphalan HCl, 5 mg/ml | >240 min |
| Methotrexate, 25 mg/ml | >240 min |
| Mitomycin-C, 0.5 mg/ml | >240 min |
| Mitoxantrone HCl, 2 mg/ml | >240 min |
| Oxaliplatin, 2 mg/ml | >240 min |
| Paclitaxel, 6 mg/ml | >240 min |
| Retrovir, 10 mg/ml | >240 min |
| ThioTEPA, 10 mg/ml | 27.1 min. |
| Trisonex, 1 mg/ml | >240 min |
| Vidaza (Azacitidine), 25 mg/ml | >240 min |
| Vincristine Sulfate, 1 mg/ml | >240 min |
| Fentanyl Citrate Injection, 50mcg/ml | >240 min |
| Gastric Acid | >240 min |
| Fentanyl Citrate:Xylazine HCl, 50:50 | >240 min |
Note: Warnings are explicitly provided for Carmustine and ThioTEPA due to extremely low permeation times.
Dark Blue Glove Performance:
| Chemotherapy Drug / Substance | Minimum Breakthrough Detection Time (minutes) |
|---|---|
| Bendamustine HCl, 5 mg/ml | >240 min |
| Bortezomib (Velcade), 1 mg/ml | >240 min |
| Busulfan, 6 mg/ml | >240 min |
| Carboplatin, 10 mg/ml | >240 min |
| Carmustine, 3.3 mg/ml | 11.0 min. |
| Carfilzomib, 2 mg/ml | >240 min |
| Cetuximab (Erbitux), 2 mg/ml | >240 min |
| Chloroquine, 50mg/ml | >240 min |
| Cisplatin, 1 mg/ml | >240 min |
| Cladribine, 1.0 mg/ml | >240 min |
| Cyclophosphamide, 20 mg/ml | >240 min |
| Cyclosporin A,100mg/ml | >240 min |
| Cytarabine HCl, 100 mg/ml | >240 min |
| Cytovene, 10 mg/ml | >240 min |
| Dacarbazine, 10 mg/ml | >240 min |
| Daunorubicin HCl, 5 mg/ml | >240 min |
| Decitabine, 5 mg/ml | >240 min |
| Docetaxel, 10 mg/ml | >240 min |
| Doxorubicin HCl, 2 mg/ml | >240 min |
| Epirubicin HCl, 2 mg/ml | >240 min |
| Etoposide, 20 mg/ml | >240 min |
| Fludarabine Phosphate, 25 mg/ml | >240 min |
| 5-Fluorouracil, 50 mg/ml | >240 min |
| Gemcitabine HCl, 38 mg/ml | >240 min |
| Idarubicin HCl, 1 mg/ml | >240 min |
| Ifosfamide, 50 mg/ml | >240 min |
| Irinotecan HCl, 20 mg/ml | >240 min |
| Mechlorethamine HCl, 1 mg/ml | >240 min |
| Melphalan HCl, 5 mg/ml | >240 min |
| Methotrexate, 25 mg/ml | >240 min |
| Mitomycin-C, 0.5 mg/ml | >240 min |
| Mitoxantrone HCl, 2 mg/ml | >240 min |
| Oxaliplatin, 2 mg/ml | >240 min |
| Paclitaxel, 6 mg/ml | >240 min |
| Retrovir, 10 mg/ml | >240 min |
| ThioTEPA, 10 mg/ml | 26.0 min. |
| Trisonex, 1 mg/ml | >240 min |
| Vidaza (Azacitidine), 25 mg/ml | >240 min |
| Vincristine Sulfate, 1 mg/ml | >240 min |
| Fentanyl Citrate Injection, 50mcg/ml | >240 min |
| Gastric Acid | >240 min |
| Fentanyl Citrate:Xylazine HCl, 50:50 | >240 min |
Note: Warnings are explicitly provided for Carmustine and ThioTEPA due to extremely low permeation times.
2. Sample Size and Data Provenance for the Test Set:
The document does not explicitly state the sample size (number of gloves tested for each substance) used for these permeation tests. It only lists the test results. The data provenance is stated as being tested "in accordance with ASTM D6978-05 standards," which implies a standardized laboratory testing setting. There is no information regarding the country of origin of the data or whether it was retrospective or prospective.
3. Number of Experts and Qualifications for Ground Truth:
This section is not applicable to this type of device and study. The "ground truth" here is the physical measurement of chemical permeation, which is determined by laboratory instrumentation and protocols defined by the ASTM standard, not by human expert interpretation or consensus.
4. Adjudication Method for the Test Set:
This section is not applicable. Adjudication methods like "2+1" or "3+1" are used in studies involving human readers/experts evaluating data (e.g., medical images) to establish a consensus ground truth. In this study, the "ground truth" is a direct physical measurement.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
This section is not applicable. MRMC studies are performed for AI/software devices where human readers interpret medical data, often comparing human performance with and without AI assistance. This document describes chemical permeation tests of gloves, not a diagnostic or prognostic medical device involving human interpretation.
6. Standalone (Algorithm Only) Performance:
This section is not applicable. This refers to the performance of an AI algorithm without human intervention. The device in question is a physical glove, not an algorithm.
7. Type of Ground Truth Used:
The "ground truth" for this study is a physical measurement of chemical permeation through the glove material, determined by laboratory testing protocols as defined by the ASTM D6978-05 standards. It is not derived from expert consensus, pathology, or outcomes data.
8. Sample Size for the Training Set:
This section is not applicable. This study does not involve a training set as it's not an AI/machine learning model development context.
9. How the Ground Truth for the Training Set was Established:
This section is not applicable for the reasons stated above.
§ 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.