(69 days)
Blue Non Sterile Powder Free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs 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 using ASTM D6978-05 and will be labeled with a statement of compliance and a summary of the testing results.
Blue Non Sterile Powder Free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs are Class I Patient Examination Gloves and Specialty Chemotherapy Gloves. They are ambidextrous, and come in different sizes - Extra Small, Small, Medium, Large and Extra Large. Gloves meet the specification of ASTM D6319-10 and have been tested for resistance to permeation by chemotherapy drugs as per ASTM D6978-05, as guide lined by the FDA Medical Glove Guidance Manual.
The provided text describes testing and acceptance criteria for Blue Non Sterile Powder Free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs (K173942), focusing on their resistance to chemotherapy drug permeation. This is a medical device, not an AI/ML-based diagnostic or prognostic tool, therefore, many of the typical questions regarding AI model evaluation (like sample size for training set, number of experts for ground truth, MRMC studies, etc.) are not applicable to this submission.
The study proves the device's substantial equivalence to a predicate device (K172525) and its performance according to established industry standards.
Here's an analysis of the acceptance criteria and the study performance for the chemotherapy drug permeation aspect, as that's where specific performance data is provided:
Acceptance Criteria and Reported Device Performance
The key performance criterion for these gloves regarding chemotherapy drugs is the "Minimum Breakthrough Detection Time" as per ASTM D6978-05. While specific "acceptance criteria" (e.g., "must be >X minutes") are not explicitly stated as numerical thresholds for all drugs, the implicit acceptance criterion is to demonstrate a breakthrough time for each tested chemotherapy drug, and for certain drugs, specifically those known to have low permeation times (Carmustine and Thiotepa), to explicitly state their observed values, even if low. For the majority of drugs, the goal is often to demonstrate a breakthrough time exceeding a common testing duration (e.g., >240 minutes, which is 4 hours).
Table of Acceptance Criteria (Implicit) and Reported Device Performance:
| Tested Chemotherapy Drug | Implicit Acceptance Criteria (based on common medical glove standards and the data presented) | Reported Device Performance (Minimum Breakthrough Detection Time in minutes) |
|---|---|---|
| Bleomycin Sulfate | Demonstrate permeation data; ideally >240 min | >240 |
| Busulfan | Demonstrate permeation data; ideally >240 min | >240 |
| Carboplatin | Demonstrate permeation data; ideally >240 min | >240 |
| Carmustine | Demonstrate permeation data; acknowledge low time if applicable | 12.4 |
| Cisplatin | Demonstrate permeation data; ideally >240 min | >240 |
| Chloroquine | Demonstrate permeation data; ideally >240 min | >240 |
| Cyclophosphamide | Demonstrate permeation data; ideally >240 min | >240 |
| Cyclosporin | Demonstrate permeation data; ideally >240 min | >240 |
| Cytarabine HCI | Demonstrate permeation data; ideally >240 min | >240 |
| Dacarbazine | Demonstrate permeation data; ideally >240 min | >240 |
| Daunorubicin HCI | Demonstrate permeation data; ideally >240 min | >240 |
| Docetaxel | Demonstrate permeation data; ideally >240 min | >240 |
| Doxorubicin Hydrochloride | Demonstrate permeation data; ideally >240 min | >240 |
| Epirubicin (Ellence) | Demonstrate permeation data; ideally >240 min | >240 |
| Etoposide | Demonstrate permeation data; ideally >240 min | >240 |
| Fludarabine | Demonstrate permeation data; ideally >240 min | >240 |
| Fluorouracil | Demonstrate permeation data; ideally >240 min | >240 |
| Gemcitabine | Demonstrate permeation data; ideally >240 min | >240 |
| Idarubicin | Demonstrate permeation data; ideally >240 min | >240 |
| Ifosfamide | Demonstrate permeation data; ideally >240 min | >240 |
| Irinotecan | Demonstrate permeation data; ideally >240 min | >240 |
| Mechlorethamine HCI | Demonstrate permeation data; ideally >240 min | >240 |
| Melphalan | Demonstrate permeation data; ideally >240 min | >240 |
| Methotrexate | Demonstrate permeation data; ideally >240 min | >240 |
| Mitomycin | Demonstrate permeation data; ideally >240 min | >240 |
| Mitoxantrone | Demonstrate permeation data; ideally >240 min | >240 |
| Oxaliplatin | Demonstrate permeation data; ideally >240 min | >240 |
| Paclitaxel | Demonstrate permeation data; ideally >240 min | >240 |
| Paraplatin | Demonstrate permeation data; ideally >240 min | >240 |
| Retrovir | Demonstrate permeation data; ideally >240 min | >240 |
| Rituximab | Demonstrate permeation data; ideally >240 min | >240 |
| Thiotepa | Demonstrate permeation data; acknowledge low time if applicable | 24.4 |
| Topotecane | Demonstrate permeation data; ideally >240 min | >240 |
| Trisonex | Demonstrate permeation data; ideally >240 min | >240 |
| Velcade | Demonstrate permeation data; ideally >240 min | >240 |
| Vincristine Sulfate | Demonstrate permeation data; ideally >240 min | >240 |
The manufacturer clearly states the two drugs with "extremely low permeation times" (Carmustine and Thiotepa), indicating transparency and adherence to relevant standards (ASTM D6978-05).
Study Details:
This submission is for a medical device (gloves), not an AI/ML diagnostic. Therefore, the following points typical for AI/ML device evaluations are not applicable (N/A):
-
Sample Size used for the Test Set and the Data Provenance:
- Test Set Sample Size: The document does not specify a "sample size" in terms of number of gloves tested for each drug, but rather the performance against a list of chemicals. ASTM D6978-05 (Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs) outlines the methodology for such testing. Typically, this would involve a statistically significant number of specimens to ensure reproducibility and reliability, but the exact number isn't in this summary.
- Data Provenance: The testing was done on the "Proposed Device" manufactured by Central Medicare Sdn. Bhd., located in Teluk Intan, Perak, Malaysia. The data is prospective, a result of new testing on the device.
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Number of Experts used to establish the ground truth for the test set and the qualifications of those experts: N/A for this type of device. The "ground truth" is established by physical/chemical testing as per recognized ASTM standards.
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Adjudication method (e.g., 2+1, 3+1, none) for the test set: N/A. Physical/chemical testing does not involve human adjudication in this context.
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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: N/A. This is not an AI/ML device.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: N/A. This is a physical product, not an algorithm.
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The type of ground truth used:
- The ground truth for chemotherapy drug permeation is established through laboratory testing using standardized methods (ASTM D6978-05), which measures the time it takes for a chemical to permeate through a material. This is an objective, quantitative measurement, not based on expert consensus, pathology, or outcomes data in the traditional medical sense.
- Other ground truths for the gloves' properties (tensile strength, elongation, freedom from holes, powder content) are established via their respective ASTM standards (e.g., ASTM D6319-10, ASTM D5151-06, ASTM D6124-06).
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The sample size for the training set: N/A. This is not an AI/ML device.
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How the ground truth for the training set was established: N/A. This is not an AI/ML device.
§ 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.