(106 days)
Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs (White) is a non-sterile 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.
Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs (White)
This document is a 510(k) premarket notification for a medical device: "Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs (White)". It does not describe an AI/ML powered device, therefore the requested information regarding acceptance criteria and studies in the context of AI/ML performance metrics (such as sample size for test/training sets, expert qualifications, adjudication methods, MRMC studies, standalone performance, and ground truth establishment) is not applicable or present in this document.
The document discusses the regulatory approval for this medical glove and lists the breakthrough times for various chemotherapy drugs, which relates to the glove's intended use and performance for that specific application.
Here's the relevant information that can be extracted from the provided text regarding device performance:
1. Table of Acceptance Criteria and Reported Device Performance
The document presents breakthrough times for various chemotherapy drugs, indicating the time it takes for the drug to permeate the glove material. While not explicitly stated as "acceptance criteria" (which would typically be a minimum breakthrough time set by a standard or manufacturer), the implicit acceptance is that the glove can be used with these drugs and its performance is characterized by these breakthrough times.
| Chemotherapy Drugs | Concentration (mg/ml) | Reported Breakthrough time (minutes) |
|---|---|---|
| Carmustine (BCNU) | 3.3 | 11.7 |
| Cisplatin | 1.0 | >240 |
| Cyclophosphamide (Cytoxan) | 20.0 | >240 |
| Dacarbazine | 10.0 | >240 |
| Doxorubixin Hydrochloride | 2.0 | >240 |
| Etoposide (Toposar) | 20.0 | >240 |
| Fluorouracil | 50.0 | >240 |
| Methotrexate | 25.0 | >240 |
| Mitomycin C | 0.5 | >240 |
| Paclitaxel (Taxol) | 6.0 | >240 |
| Thiotepa | 10.0 | 34.4 |
| Vincristine Sulfate | 1.0 | >240 |
Note: The document highlights that Carmustine and Thiotepa have "extremely low permeation times" of 11.7 and 34.4 minutes respectively, implying these are at the lower end of acceptable performance for this specific application.
2-9: Information Not Applicable / Not Provided for this Device
The remaining points (sample size for test set, data provenance, number and qualifications of experts, adjudication method, MRMC study details, standalone performance, type of ground truth for test set, sample size for training set, and how ground truth for training set was established) are standard questions for AI/ML-powered devices and are not relevant to a physical medical device like an examination glove. The provided document is a regulatory letter for a conventional medical device and does not contain information on these aspects. The "study" mentioned refers to the testing of the glove against chemotherapy drugs, not an AI/ML algorithm.
§ 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.