(108 days)
Nitrile Powder Free Examination Glove with Colloidal Oatmeal USP with Low Dermatitis Potential Claim and Tested for Use with Chemotherapy Drugs (White) is a non-sterile disposable device intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner. Is it also tested to be used against Chemotherapy Drugs.
The list of Chemotherapy Drugs tested (with breakthrough times) is as below;
Carmustine (3.3 mg/ml) 17.2 minutes
Cisplatin (1.0 mg/ml) >240 minutes
Cyclophosphamide (20 mg/ml) > 240 minutes
Dacarbazine (10.0 mg/ml) >240 minutes
Doxorubicin Hydrochloride (2.0 mg/ml) > 240 minutes
Etoposide (20 mg/ml) > 240 minutes
Fluorouracil (50 mg/ml) > 240 minutes
Methotrexate (25 mg/ml) > 240 minutes
Mitomycin C (0.5 mg/ml) > 240 minutes
Paclitaxel (6.0 mg/ml) > 240 minutes
Thiotepa (10.0 mg/ml) 36.1 minutes
Vincristine Sulfate (1.0 mg/ml) >240 minutes
Do not use with Carmustine. Do not use with Thiotepa.
Nitrile Powder Free Examination Glove with Colloidal Oatmeal USP with Low Dermatitis Potential Claim and Tested for Use with Chemotherapy Drugs (White)
This document is a 510(k) premarket notification decision letter from the FDA for a Nitrile Powder Free Examination Glove. It is not a study proving the device meets specific acceptance criteria in the context of an AI/ML medical device.
Therefore, I cannot extract the requested information like "acceptance criteria and the reported device performance," "sample size used for the test set," "number of experts used to establish ground truth," "multi reader multi case (MRMC) comparative effectiveness study," or "sample size for the training set." These concepts are relevant to the evaluation of AI/ML software, not a physical medical device like a glove, which is evaluated against different types of performance standards (e.g., physical properties, barrier protection, biocompatibility, chemical resistance).
The provided text only includes:
- Trade/Device Name: Nitrile Powder Free Examination Glove with Colloidal Oatmeal USP with Low-Dermatitis Potential Claim and Tested For Use with Chemotherapy Drugs (White)
- Regulation Number: 21 CFR 880.6250
- Regulation Name: Patient Examination Glove
- Regulatory Class: Class I
- Product Code: LZA, LZC
- Indications for Use: "Nitrile Powder Free Examination Glove with Colloidal Oatmeal USP with Low Dermatitis Potential Claim and Tested for Use with Chemotherapy Drugs (White) is a non-sterile disposable device intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner. Is it also tested to be used against Chemotherapy Drugs."
- Chemotherapy Drugs Tested with Breakthrough Times: A table listing specific chemotherapy drugs and their breakthrough times in minutes. This table serves as performance data for the glove's resistance to certain chemicals, but it does not represent "acceptance criteria" in the AI/ML context nor is the study design detailed for how these breakthrough times were determined (e.g., sample size of gloves tested).
- Cautions: "Do not use with Carmustine. Do not use with Thiotepa." (These warnings are based on the breakthrough times being short).
To answer your prompt for an AI/ML device, I would need a different type of document, specifically a study report or a 510(k) submission for an AI/ML product.
§ 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.