(307 days)
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:
- Carmustine: 11.2 minutes
- 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:
- Carmustine: 10.7 minutes
- 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:
- Carmustine: 11.0 minutes
- 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.
§ 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.