(83 days)
The Medline Glide-On 3G Vinyl Examination Gloves (Tested for use with Chemotherapy Drugs) are a disposable device intended for medical purposes that are worn on the examiner's hands or fingers to prevent contamination between the patient and examiner.
The gloves were tested for use with chemotherapy drugs per ASTM D6978-05 (Reapproved 2013) Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs.
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The provided FDA document (K202179) is a 510(k) premarket notification for Medline Glide-On 3G Vinyl Examination Gloves, which were tested for use with chemotherapy drugs. This document focuses on the substantial equivalence determination for a medical device (gloves) and their material properties, specifically their resistance to chemotherapy drug permeation.
The information requested in your prompt (acceptance criteria and study details for an AI/device performance evaluation) is not applicable to this type of FDA submission. This is not a submission for an AI-powered diagnostic device, but rather for a physical medical glove. Therefore, there is no AI algorithm, no test set for an algorithm, no ground truth established by experts, no MRMC study, and no training set involved in this document.
However, I can extract the closest equivalent information from the document regarding the "acceptance criteria" and the "study that proves the device meets the acceptance criteria" in the context of these gloves:
Acceptance Criteria and Device Performance (Closest Equivalent for a Physical Device)
The "acceptance criteria" here relate to the ability of the gloves to resist permeation by various chemotherapy drugs, as defined by the ASTM D6978-05 standard. The "reported device performance" is the actual time it took for the drugs to break through the glove material.
| Chemotherapy Drug | Acceptance Criteria (Implicit from Industry Standard/Expected Performance) | Reported Device Performance (Minimum Breakthrough Detection) | Comment |
|---|---|---|---|
| Carmustine | High resistance (longer breakthrough time) is desirable. | 11.4 minutes | WARNING: DO NOT USE WITH CARMUSTINE (Indicates this performance did not meet safe use criteria) |
| Cisplatin | High resistance (longer breakthrough time) is desirable. | >240 minutes | Exceeds 4 hours, indicating good resistance for this drug. |
| Cyclophosphamide | High resistance (longer breakthrough time) is desirable. | >240 minutes | Exceeds 4 hours, indicating good resistance for this drug. |
| Dacarbazine | High resistance (longer breakthrough time) is desirable. | >240 minutes | Exceeds 4 hours, indicating good resistance for this drug. |
| Doxorubicin HCl | High resistance (longer breakthrough time) is desirable. | >240 minutes | Exceeds 4 hours, indicating good resistance for this drug. |
| Etoposide | High resistance (longer breakthrough time) is desirable. | >240 minutes | Exceeds 4 hours, indicating good resistance for this drug. |
| Fluorouracil | High resistance (longer breakthrough time) is desirable. | >240 minutes | Exceeds 4 hours, indicating good resistance for this drug. |
| Methotrexate | High resistance (longer breakthrough time) is desirable. | >240 minutes | Exceeds 4 hours, indicating good resistance for this drug. |
| Paclitaxel | High resistance (longer breakthrough time) is desirable. | >240 minutes | Exceeds 4 hours, indicating good resistance for this drug. |
| Thiotepa | High resistance (longer breakthrough time) is desirable. | 17.4 minutes | WARNING: DO NOT USE WITH THIOTEPA (Indicates this performance did not meet safe use criteria) |
Regarding the other points in your prompt:
- 2. Sample size used for the test set and the data provenance: The document does not specify the sample size (number of gloves tested) or the exact provenance of the test data (e.g., country of origin, retrospective/prospective). The testing method specified is ASTM D6978-05.
- 3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for glove permeation is established by laboratory measurement using a standardized test method (ASTM D6978-05), not by human expert consensus or radiologists.
- 4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. The "ground truth" is a direct measurement based on a physical test.
- 5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done...: Not applicable. This is for evaluating diagnostic performance with human readers, which is not relevant for a physical glove.
- 6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable. There is no algorithm.
- 7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): The "ground truth" for glove permeation is based on the direct results from the ASTM D6978-05 standard test method for assessing permeation by chemotherapy drugs. This involves a specific experimental setup to detect the breakthrough time of a chemical.
- 8. The sample size for the training set: Not applicable. This product does not involve machine learning or a training set.
- 9. How the ground truth for the training set was established: Not applicable.
In summary, the provided document details the testing of physical gloves against chemical permeation standards, not the performance of an AI or diagnostic 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.