(150 days)
Latex Powder Free Surgical Glove with Protein Labeling Claim of 50 Microgram or Less per Gram of Glove and Tested for Use with Chemotherapy Drugs is made of natural rubber intended to be worn by operating personnel to protect a surgical wound from contamination. It is also tested to be used against Chemotherapy Drugs.
These gloves were tested for use with chemotherapy drugs as per ASTM D6978-05 (Reapproved 2019) Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs.
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This document is a 510(k) premarket notification from the FDA, specifically for a Latex Powder Free Surgical Glove with Protein Labeling Claim of 50 Microgram or Less per Gram of Glove and Tested for Use with Chemotherapy Drugs.
The request asks for information typically found in an AI/Software as a Medical Device (SaMD) study, such as acceptance criteria, sample sizes for training and testing, expert qualifications, and MRMC studies. However, this document describes a physical medical device (surgical gloves), not an AI/SaMD.
Therefore, I cannot provide the requested information because it is not applicable to the provided document. The document details the device's intended use and performance against chemotherapy drugs, but it does not involve any AI/ML components or studies of human-in-the-loop performance with AI.
To directly answer your questions based on the provided document:
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A table of acceptance criteria and the reported device performance:
The acceptance criteria for chemotherapy drug permeation are implicitly defined by the "Minimum Breakthrough Detection Time in Minutes" columns, and the reported device performance is the value in that column. The standard used is ASTM D6978-05 (Reapproved 2019):- Chemotherapy Drug and Concentration | Minimum Breakthrough Detection Time in Minutes (Acceptance Criteria & Reported Performance)
- Carmustine (BCNU) (3.3 mg/ml) | 12.5
- Cisplatin (1 mg/ml) | > 240
- Cyclophosphamide (Cytoxan) (20.0 mg/ml) | > 240
- Dacarbazine (10 mg/ml) | > 240
- Doxorubicin HCI (2.0 mg/ml) | > 240
- Etoposide (20.0 mg/ml) | > 240
- Fluorouracil (50.0 mg/ml) | > 240
- Methotrexate (25 mg/ml) | > 240
- Mitomycin C (0.5 mg/ml) | > 240
- Paclitaxel (6.0 mg/ml) | > 240
- Thiotepa (10.0 mg/ml) | 13.6
- Vincristine Sulfate (1.0 mg/ml) | > 240
- Note: The document also explicitly warns against using the gloves with Carmustine (BCNU) and Thiotepa due to low permeation times.
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Sample sizes used for the test set and the data provenance: Not applicable to this type of device. The testing methodology for ASTM D6978-05 would define the sample sizes for glove permeation testing, but this is not detailed in the FDA letter. Data provenance would be from laboratory testing.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for physical device performance is established through standardized laboratory testing, not human expert consensus.
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Adjudication method: Not applicable.
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If a multi reader multi case (MRMC) comparative effectiveness study was done: Not applicable. This is for AI/SaMD, not physical gloves.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
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The type of ground truth used: Laboratory test results based on ASTM D6978-05 for chemotherapy drug permeation and potentially other standards for protein labeling claims.
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The sample size for the training set: Not applicable. This is a manufactured product, not an AI model.
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How the ground truth for the training set was established: Not applicable.
§ 878.4460 Non-powdered surgeon's glove.
(a)
Identification. A non-powdered surgeon's glove is a device intended to be worn on the hands of operating room personnel to protect a surgical wound from contamination. A non-powdered surgeon's 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).