(30 days)
A patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner. Gloves have been tested for use with chemotherapy drugs per ASTM D6978-05 (Reapproved 2019) Standard Practice for Assessment of Resistance of Medical Cloves to Permeation by Chemotherapy Drugs.
The Harbour Health Powder Free Nitrile Examination Glove, Blue (Tested for Use with Chemotherapy Drugs) is a non-sterile, single use only, disposable examination glove intended for medical purposes to be worn by examiners to prevent contamination between the examiner. The gloves are nitrile, powder free, and blue in color. They feature an ambidextrous design with textured fingertips, straight fingers, and a beaded cuff. The gloves are available in sizes small, medium, large, and extra-large, packaged in a chipboard box.
The provided text describes the regulatory clearance (K210944) for a Powder Free Nitrile Examination Glove, Blue (Tested for Use with Chemotherapy Drugs) manufactured by Harbour Health LLC. This document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting a full clinical study for a novel device.
Therefore, the requested information pertaining to acceptance criteria and performance studies for an AI/ML-driven medical device, such as sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, and ground truth establishment for training and test sets, is not relevant to this document. This document describes the bench testing and biocompatibility assessments of a physical medical device (gloves), not an AI/ML system.
However, I can extract the acceptance criteria and reported performance related to the glove's resistance to chemotherapy drug permeation, as this is the primary performance claim highlighted in the document.
Acceptance Criteria and Reported Device Performance for Chemotherapy Drug Permeation
The device's performance regarding chemotherapy drug permeation is established by testing according to ASTM D6978-05 (Reapproved 2019) Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs. The acceptance criteria are implicitly defined by the reported "Breakthrough Detection Time" for each drug, with the maximum testing time being 240 minutes. Gloves are generally considered resistant if the breakthrough time is longer, ideally exceeding the 240-minute timeframe. A warning is given for drugs with significantly lower breakthrough times.
1. Table of Acceptance Criteria and Reported Device Performance:
| No. | Chemotherapy Drug Tested | Concentration | Acceptance Criteria (Breakthrough Detection Time - Minutes) | Reported Device Performance (Breakthrough Detection Time - Minutes) |
|---|---|---|---|---|
| 1 | Busulfan | 6 mg/ml (6,000 ppm) | > 240 (Ideal) | > 240 |
| 2 | Carboplatin | 10 mg/ml (10,000 ppm) | > 240 (Ideal) | > 240 |
| 3 | Carmustine (BCNU) | 3.3 mg/ml (3,300 ppm) | > 240 (Ideal) | 14.5* |
| 4 | Cisplatin | 1.0 mg/ml (1,000 ppm) | > 240 (Ideal) | > 240 |
| 5 | Cyclophosphamide (Cytoxan) | 20.0 mg/ml (20,000 ppm) | > 240 (Ideal) | > 240 |
| 6 | Cytarabine | 100 mg/ml (100,000 ppm) | > 240 (Ideal) | > 240 |
| 7 | Dacarbazine | 10.0 mg/ml (10,000 ppm) | > 240 (Ideal) | > 240 |
| 8 | Docetaxel | 10 mg/ml (10,000 ppm) | > 240 (Ideal) | > 240 |
| 9 | Doxorubicin HCI | 2.0 mg/ml (2,000 ppm) | > 240 (Ideal) | > 240 |
| 10 | Etoposide | 20.0 mg/ml (20,000 ppm) | > 240 (Ideal) | > 240 |
| 11 | Fluorouracil | 50.0 mg/ml (50,000 ppm) | > 240 (Ideal) | > 240 |
| 12 | Ifosfamide | 50 mg/ml (50,000 ppm) | > 240 (Ideal) | > 240 |
| 13 | Mechlorethamine HCI | 1 mg/ml (1,000 ppm) | > 240 (Ideal) | > 240 |
| 14 | Methotrexate | 25 mg/ml (25,000 ppm) | > 240 (Ideal) | > 240 |
| 15 | Mitomycin C | 0.5 mg/ml (500 ppm) | > 240 (Ideal) | > 240 |
| 16 | Mitoxantrone | 2 mg/ml (2,000 ppm) | > 240 (Ideal) | > 240 |
| 17 | Paclitaxel | 6.0 mg/ml (6,000 ppm) | > 240 (Ideal) | > 240 |
| 18 | Thiotepa | 10.0 mg/ml (10,000 ppm) | > 240 (Ideal) | 47.4* |
| 19 | Vincristine Sulfate | 1.0 mg/ml (1,000 ppm) | > 240 (Ideal) | > 240 |
* WARNING: Not recommended for use with Carmustine and Thiotepa due to low permeation times. The acceptance criteria for these specific drugs are effectively the reported breakthrough times, with the caveat that they are deemed insufficient for recommended use.
2. Sample size used for the test set and the data provenance:
For the chemotherapy drug permeation testing (ASTM D6978-05), the document does not specify the exact sample size (number of gloves tested) per drug, nor the country of origin of the test samples. The testing described is bench testing, not involving human data. The data provenance is laboratory-based testing data, not clinical. The nature of the testing is analogous to prospective testing for product quality control.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
Not applicable. The ground truth for chemotherapy drug permeation testing is established by direct measurement using specified laboratory methods and instrumentation (ASTM D6978-05), not by expert consensus or interpretation of medical images.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
Not applicable, as the "ground truth" is determined by objective physical measurements per a standard test method (ASTM D6978-05), not by human interpretation 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 is a physical medical device (glove), not an AI/ML-driven device that assists human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. This is a physical medical device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
The ground truth is established through standardized laboratory-based physical and chemical property testing as defined by ASTM D6978-05 (for chemotherapy permeation) and other ASTM standards (e.g., D6319-19 for general glove properties).
8. The sample size for the training set:
Not applicable. This is a physical medical device; there is no "training set" in the context of machine learning. The manufacturing process and formulation could be considered analogous to a "training" phase in a very abstract sense, where product development aims to meet performance specifications.
9. How the ground truth for the training set was established:
Not applicable. In the context of a physical medical device, "ground truth" is established by adherence to recognized voluntary consensus standards and validated test methods (e.g., ASTM standards) throughout manufacturing and quality control.
§ 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.