(165 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. These 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.
Sterile Powder Free Nitrile Examination Gloves, Blue Colored. Tested For Use with Chemotherapy Drugs, with Non-Pyrogenic Labeling Claim
This document is a 510(k) premarket notification from the FDA regarding "Sterile Powder Free Nitrile Examination Gloves, Blue Colored. Tested For Use with Chemotherapy Drugs, with Non-Pyrogenic Labeling Claim."
The document does not describe the acceptance criteria and a study for an AI-powered device. Instead, it outlines the performance of medical gloves against chemotherapy drug permeation. Therefore, most of the requested information regarding AI device studies cannot be extracted.
However, I can provide the acceptance criteria and reported device performance related to chemotherapy drug permeation for the gloves as presented in the document.
1. A table of acceptance criteria and the reported device performance
For the specific context of these gloves and chemotherapy drug permeation, the "acceptance criteria" appear to be implied by the minimum breakthrough detection times. The device's performance is the reported breakthrough time for each drug.
| Chemotherapy Drug and Concentration | Acceptance Criteria (Minimum Breakthrough Detection Time) | Reported Device Performance (Breakthrough Detection Time in Minutes) |
|---|---|---|
| Carmustine (BCNU) (3.3 mg/ml) | N/A (Tested per ASTM D6978-05) | 30.1 |
| Cisplatin (1.0 mg/ml) | N/A (Tested per ASTM D6978-05) | >240 |
| Cyclophosphamide (Cytoxan) (20 mg/ml) | N/A (Tested per ASTM D6978-05) | >240 |
| Cytarabine (100 mg/ml) | N/A (Tested per ASTM D6978-05) | >240 |
| Dacarbazine (DTIC) (10.0 mg/ml) | N/A (Tested per ASTM D6978-05) | >240 |
| Doxorubicin Hydrochloride (2.0 mg/ml) | N/A (Tested per ASTM D6978-05) | >240 |
| Etoposide (20.0 mg/ml) | N/A (Tested per ASTM D6978-05) | >240 |
| Fluorouracil (50.0 mg/ml) | N/A (Tested per ASTM D6978-05) | >240 |
| Ifosfamide (50.0 mg/ml) | N/A (Tested per ASTM D6978-05) | >240 |
| Methotrexate (25 mg/ml) | N/A (Tested per ASTM D6978-05) | >240 |
| Mitomycin C (0.5 mg/ml) | N/A (Tested per ASTM D6978-05) | >240 |
| Mitoxantrone (2.0 mg/ml) | N/A (Tested per ASTM D6978-05) | >240 |
| Paclitaxel (Taxol) (6.0 mg/ml) | N/A (Tested per ASTM D6978-05) | >240 |
| Thiotepa (10.0 mg/ml) | N/A (Tested per ASTM D6978-05) | 50.5 |
| Vincristine Sulfate (1.0 mg/ml) | N/A (Tested per ASTM D6978-05) | >240 |
Note: The phrase "minimum breakthrough detection time" in the table heading implies these are the observed times. The standard ASTM D6978-05 would define the methodology and potential performance requirements, but the document itself doesn't explicitly state a pass/fail threshold for these times. However, the subsequent note highlights drugs with "extremely low permeation times of less than 60 minutes," suggesting a 60-minute threshold might be implicitly relevant for practical use considerations.
The document does not provide information for the following points as they are typically relevant for AI/software-as-a-medical-device (SaMD) studies, not for the physical examination gloves described:
- Sample size used for the test set and the data provenance
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Adjudication method
- If a multi reader multi case (MRMC) comparative effectiveness study was done
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- The sample size for the training set
- How the ground truth for the training set was established
§ 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.