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A powder-free 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.

In addition, the glove was tested for use with chemotherapy drugs in accordance with ASTM D6978-05 Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs:

The following chemotherapy drugs have been tested with the white glove:
Cyclophosphamide (Cytoxan) 20.0mg/ml > 240
Doxorubicin Hydrochloride 2.0mg/ml > 240
Etoposide (Toposar) 20.0mg/ml > 240
Fluorouracil 50.0mg/ml > 240
Paclitaxel (Taxol) 6.0mg/ml > 240
Cisplatin 1.0mg/ml > 240
Dacarbazine (DTIC) 10.0mg/ml > 240
Carmustine (BCNU) 3.3mg/ml 11.2
Thiotepa (THT) 10.0mg/ml 25.2

*Please note that the following 2 drugs have extremely low permeation times:

1. Carmustine: 11.2 minutes
2. Thiotepa: 25.2 minutes

Warning: Do not use with Carmustine (BCNU) and Thiotepa (THT).

The following chemotherapy drugs have been tested with the blue glove:
Cyclophosphamide (Cytoxan) 20.0mg/ml > 240
Doxorubicin Hydrochloride 2.0mg/ml > 240
Etoposide (Toposar) 20.0mg/ml > 240
Fluorouracil 50.0mg/ml > 240
Paclitaxel (Taxol) 6.0mg/ml > 240
Cisplatin 1.0mg/ml > 240
Dacarbazine (DTIC) 10.0mg/ml > 240
Carmustine (BCNU) 3.3mg/ml 10.7
Thiotepa (THT) 10.0mg/ml 21.5

*Please note that the following 2 drugs have extremely low permeation times:

1. Carmustine: 10.7 minutes
2. Thiotepa: 21.5 minutes

Warning: Do not use with Carmustine (BCNU) and Thiotepa (THT).

The following chemotherapy drugs have been tested with the black glove:
Cyclophosphamide (Cytoxan) 20.0mg/ml > 240
Doxorubicin Hydrochloride 2.0mg/ml > 240
Etoposide (Toposar) 20.0mg/ml > 240
Fluorouracil 50.0mg/ml > 240
Paclitaxel (Taxol) 6.0mg/ml > 240
Cisplatin 1.0mg/ml > 240
Dacarbazine (DTIC) 10.0mg/ml > 240
Carmustine (BCNU) 3.3mg/ml 11.0
Thiotepa (THT) 10.0mg/ml 11.1

*Please note that the following 2 drugs have extremely low permeation times:

1. Carmustine: 11.0 minutes
2. Thiotepa: 11.1 minutes

Warning: Do not use with Carmustine (BCNU) and Thiotepa (THT).

Powder-Free Nitrile Examination Glove (White Colored, Blue Colored, and Black Colored) Tested for Use with Chemotherapy Drugs

This document is a 510(k) premarket notification from the FDA regarding "Powder-Free Nitrile Examination Glove (White Colored, Blue Colored, and Black Colored) Tested for Use with Chemotherapy Drugs." It does not describe an AI/ML powered device, and therefore the acceptance criteria and study information requested in the prompt are not applicable.

The document provides information on the breakthrough detection times of various chemotherapy drugs when tested with the gloves, as per ASTM D6978-05. It clearly states the permeation times for different chemotherapy drugs and warns against the use of these gloves with Carmustine and Thiotepa due to their extremely low permeation times.

Since the prompt asks for information pertaining to an AI/ML powered device, and this document describes a physical medical device (examination gloves), a direct answer to the prompt's specific questions about AI/ML device performance, ground truth establishment, expert adjudication, and MRMC studies cannot be provided from the given text.

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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.

Sterile Powder Free Nitrile Examination Glove, Blue Colored, with Non-Pyrogenic Labeling Claim; Sterile Powder Free Nitrile Examination Glove, White Colored, with Non-Pyrogenic Labeling Claim

The provided text is an FDA 510(k) clearance letter for a medical device: "Sterile Powder Free Nitrile Examination Glove, Blue Colored, with Non-Pyrogenic Labeling Claim" and "Sterile Powder Free Nitrile Examination Glove, White Colored, with Non-Pyrogenic Labeling Claim."

This document grants substantial equivalence based on the device's intended use as a patient examination glove, which is "a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner."

The FDA letter does not include information about AI/ML device performance, acceptance criteria, test set details, expert ground truth establishment, MRMC studies, or any of the other specific questions related to AI/ML device validation. These are standard requirements for AI/ML-driven medical devices, but this document pertains to a Class I medical device (gloves), which typically undergo different types of evaluation (e.g., biocompatibility, physical properties, sterility, and non-pyrogenicity) rather than AI/ML performance studies.

Therefore, it is not possible to extract the requested information from the provided text, as it describes the regulatory clearance for examination gloves, not an AI/ML powered device.

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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.

POWDER FREE NITRILE EXAMINATION GLOVE, WHITE

I am sorry, but the provided document is a letter from the FDA regarding the 510(k) clearance for a "Powder Free Nitrile Examination Glove, White". It details the regulatory classification and indications for use of the device.

This document does not contain information about:

• Acceptance criteria and reported device performance (in a table or otherwise).
• Details of a study (sample sizes, data provenance, ground truth, expert qualifications, adjudication methods).
• Multi-reader multi-case (MRMC) comparative effectiveness studies or standalone algorithm performance.
• Training set details.

Therefore, I cannot fulfill your request for this specific document as the information you are asking for is not present within the provided text.

Ask a specific question about this device