(110 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 gloves were tested for use with chemotherapy drugs in accordance with ASTMD6978-05 Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs:
| Test Chemotherapy Drug and Concentration | Minimum Breakthrough Detection Time (Minutes) |
|---|---|
| Cisplatin, 1.0mg/ml (1,000ppm) | >240 |
| Cyclophosphamide (Cytoxan), 20mg/ml (20,000ppm) | >240 |
| Carmustine (BCNU), 3.3mg/ml (3,300ppm) | 0.53 |
| Dacarbazine (DTIC), 10.0mg/ml (10,000ppm) | >240 |
| Doxorubicin Hydrochloride, 2.0mg/ml (2,000ppm) | >240 |
| Etoposide (Toposar), 20.0mg/ml (20,000ppm) | >240 |
| Fluorouracil, 50.0mg/ml (50,000ppm) | >240 |
| Paclitaxel (Taxol), 6.0mg/ml (6,000ppm) | >240 |
| Thiotepa, 10.0mg/ml (10,000ppm) | 75.54 |
Please note that the following drugs have low permeation time of less than 240 minutes: Carmustine (BCNU), 3.3mg/ml (3,300ppm) Thiotepa, 10.0mg/ml (10,000ppm)
Prescription Use (Part 21 CFR 801 Subpart D) AND/OR Over-The-Counter Use (21 CFR 801 Subpart C)
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This document describes a 510(k) premarket notification for "Blue Powder Free Nitrile Examination Gloves Tested For Use With Chemotherapy Drugs (Non-Sterile)". The primary purpose of this submission is to demonstrate substantial equivalence to legally marketed predicate devices for general patient examination glove use, and additionally, to provide data on the gloves' resistance to permeation by chemotherapy drugs.
As such, the information provided focuses on the testing for chemotherapy drug permeation.
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are implicitly defined by the test standard ASTM D6978-05, which is a standard practice for assessing medical gloves for permeation by chemotherapy drugs. While the document doesn't explicitly state a "pass/fail" threshold for breakthrough time (e.g., all drugs must be > X minutes), it does highlight drugs with permeation times less than 240 minutes, implying that longer breakthrough times are generally more desirable. The reported performance is the minimum breakthrough detection time for each drug.
| Test Chemotherapy Drug and Concentration | Acceptance Criteria (Implicit) | Reported Device Performance (Minimum Breakthrough Detection Time) |
|---|---|---|
| Cisplatin, 1.0mg/ml (1,000ppm) | Longer breakthrough time is desirable. | >240 minutes |
| Cyclophosphamide (Cytoxan), 20mg/ml (20,000ppm) | Longer breakthrough time is desirable. | >240 minutes |
| Carmustine (BCNU), 3.3mg/ml (3,300ppm) | Longer breakthrough time is desirable. | 0.53 minutes |
| Dacarbazine (DTIC), 10.0mg/ml (10,000ppm) | Longer breakthrough time is desirable. | >240 minutes |
| Doxorubicin Hydrochloride, 2.0mg/ml (2,000ppm) | Longer breakthrough time is desirable. | >240 minutes |
| Etoposide (Toposar), 20.0mg/ml (20,000ppm) | Longer breakthrough time is desirable. | >240 minutes |
| Fluorouracil, 50.0mg/ml (50,000ppm) | Longer breakthrough time is desirable. | >240 minutes |
| Paclitaxel (Taxol), 6.0mg/ml (6,000ppm) | Longer breakthrough time is desirable. | >240 minutes |
| Thiotepa, 10.0mg/ml (10,000ppm) | Longer breakthrough time is desirable. | 75.54 minutes |
Note on Acceptance Criteria: The document explicitly notes: "Please note that the following drugs have low permeation time of less than 240 minutes: Carmustine (BCNU), 3.3mg/ml (3,300ppm) Thiotepa, 10.0mg/ml (10,000ppm)". This indicates that while the device was tested, a breakthrough time of less than 240 minutes for these specific drugs is acknowledged and disclosed, rather than being an outright "failure". The acceptance criterion is therefore the performance according to the specified ASTM standard, with the understanding that users would be informed about the permeation characteristics.
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the sample size (number of gloves or individual tests) used for the chemotherapy drug permeation testing. It only lists the results for each drug.
The data provenance is not explicitly stated as "country of origin" or "retrospective/prospective". However, the manufacturer is Maxter Glove Manufacturing Sdn. Bhd. in Malaysia, suggesting the testing likely occurred in or was commissioned by the manufacturer, possibly in Malaysia or a testing lab accredited to perform ASTM D6978-05. The testing itself is a prospective performance test of the device.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This type of device (patient examination gloves) and the specific test (chemotherapy drug permeation) do not involve "experts" establishing a ground truth in the traditional sense of clinical diagnosis or interpretation. The "ground truth" is established by the standardized laboratory test procedure itself (ASTM D6978-05), which objectively measures the breakthrough time of the chemotherapy drugs through the glove material. The "truth" is the measured time according to the standard.
4. Adjudication Method for the Test Set
Not applicable. This is a laboratory performance test, not a subjective assessment requiring adjudication. The results are quantitative measurements.
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 performance test for a patient examination glove, not an AI-assisted diagnostic or interpretive device involving human readers.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This is a physical device (glove), not an algorithm or AI. The testing performed is an objective measurement of its physical properties.
7. The type of ground truth used
The ground truth used is objective laboratory measurement based on a standardized test method (ASTM D6978-05). This standard details how to measure the permeation of chemotherapy drugs through medical glove materials, providing a quantifiable breakthrough time.
8. The sample size for the training set
Not applicable. This is a physical device undergoing performance testing, not a machine learning model that requires a training set.
9. How the ground truth for the training set was established
Not applicable. As this is not a machine learning model, there is no training set or associated ground truth for a training set.
§ 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.