(27 days)
Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (Blue) is a nonsterile disposable device intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner. It is also tested to be used against Chemotherapy Drugs and Fentanyl Citrate.
Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (Blue) is a disposable single-use, non- sterile, blue-colored and powder-free examination glove made from nitrile latex. Gloves meet the specification of ASTM D6319-19 and have been tested for resistance to permeation by chemotherapy drugs and fentanyl citrate as per ASTM D6978-05(2019).
The provided text is a 510(k) Premarket Notification from the FDA for a medical device: "Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (Blue)".
This document does not describe the acceptance criteria or a study related to an AI/ML powered device. Instead, it details the testing and comparison of a physical medical device (gloves) against a predicate device, focusing on material properties, performance standards (like resistance to permeation by chemotherapy drugs and fentanyl citrate), and biocompatibility.
Therefore, I cannot extract the requested information regarding AI/ML device acceptance criteria or related studies from this document. The questions about sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth, and training sets are not applicable to the type of device described in this FDA submission.
However, I can extract the acceptance criteria and performance data for the physical device as described:
1. Table of Acceptance Criteria and Reported Device Performance:
The primary performance criterion for the "Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (Blue)" is its resistance to permeation by chemotherapy drugs and fentanyl citrate. The acceptance criterion is a minimum breakthrough detection time for each substance.
| Chemotherapy Drug and Concentration | Acceptance Criteria (Minimum Breakthrough Detection Time in Minutes) | Reported Device Performance (Minimum Breakthrough Detection Time in Minutes) |
|---|---|---|
| Carmustine, 3.3 mg/ml | N/A (Tested to determine time) | 10.2 |
| Cisplatin, 1.0 mg/ml | N/A (Tested to determine time) | >240 |
| Cyclophosphamide, 20.0 mg/ml | N/A (Tested to determine time) | >240 |
| Dacarbazine, 10.0 mg/ml | N/A (Tested to determine time) | >240 |
| Doxorubicin Hydrochloride, 2.0 mg/ml | N/A (Tested to determine time) | >240 |
| Etoposide, 20.0 mg/ml | N/A (Tested to determine time) | >240 |
| Fluorouracil, 50.0 mg/ml | N/A (Tested to determine time) | >240 |
| Methotrexate, 25.0 mg/ml | N/A (Tested to determine time) | >240 |
| Mitomycin C, 0.5 mg/ml | N/A (Tested to determine time) | >240 |
| Paclitaxel, 6.0 mg/ml | N/A (Tested to determine time) | >240 |
| Thiotepa, 10.0 mg/ml | N/A (Tested to determine time) | 30.2 |
| Vincristine Sulfate, 1.0 mg/ml | N/A (Tested to determine time) | >240 |
| Bleomycin Sulfate, 15.0 mg/ml | N/A (Tested to determine time) | >240 |
| Bortezomib, 1.0 mg/ml | N/A (Tested to determine time) | >240 |
| Busulfan, 6.0 mg/ml | N/A (Tested to determine time) | >240 |
| Carboplatin, 10.0 mg/ml | N/A (Tested to determine time) | >240 |
| Chloroquine, 50.0 mg/ml | N/A (Tested to determine time) | >240 |
| Cyclosporin A, 100.0 mg/ml | N/A (Tested to determine time) | >240 |
| Cytarabine, 100.0 mg/ml | N/A (Tested to determine time) | >240 |
| Daunorubicin, 5.0 mg/ml | N/A (Tested to determine time) | >240 |
| Docetaxel, 10.0 mg/ml | N/A (Tested to determine time) | >240 |
| Epirubicin, 2.0 mg/ml | N/A (Tested to determine time) | >240 |
| Fludarabine, 25.0 mg/ml | N/A (Tested to determine time) | >240 |
| Gemcitabine, 38.0 mg/ml | N/A (Tested to determine time) | >240 |
| Idarubicin, 1.0 mg/ml | N/A (Tested to determine time) | >240 |
| Ifosfamide, 50.0 mg/ml | N/A (Tested to determine time) | >240 |
| Irinotecan, 20.0 mg/ml | N/A (Tested to determine time) | >240 |
| Mechlorethamine HCI, 1.0 mg/ml | N/A (Tested to determine time) | >240 |
| Melphalan, 5.0 mg/ml | N/A (Tested to determine time) | >240 |
| Mitoxantrone, 2.0 mg/ml | N/A (Tested to determine time) | >240 |
| Oxaliplatin, 2.0 mg/ml | N/A (Tested to determine time) | >240 |
| Paraplatin, 10.0 mg/ml | N/A (Tested to determine time) | >240 |
| Retrovir, 10.0 mg/ml | N/A (Tested to determine time) | >240 |
| Rituximab, 10.0 mg/ml | N/A (Tested to determine time) | >240 |
| Topotecan, 1.0 mg/ml | N/A (Tested to determine time) | >240 |
| Trisenox, 1.0 mg/ml | N/A (Tested to determine time) | >240 |
| Fentanyl Citrate Injection, 100mcg/2ml | N/A (Tested to determine time) | >240 |
Additional Acceptance Criteria and Performance Data (already met by similar predicate device or physical properties):
| Characteristic | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Freedom from holes | AQL 1.5% (Meets ASTM D5151-19 and ASTM D6319-19) | Pass |
| Residual Powder | Average |
§ 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.