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This device is intended for medical purpose that is worn on the examination between patient and examiner. In addition, these gloves were tested for use with the following chemotherapy drug concentrations per ASTM D6978-05(2019): The following drugs had NO breakthrough detected up to 240 minutes:
Cisplatin, 1.0 mg/ml (1,000 ppm) >240 min.
Cyclophosphamide (Cytoxan),20.0 mg/ml (20,000 ppm) >240 min.
Dacarbazine,10.0 mg/ml (10,000 ppm) >240 min.
Doxorubicin HCI, 2.0 mg/ml (2,000 ppm) >240 min.
Etoposide, 20.0 mg/ml (20,000 ppm) >240 min.
Fluorouracil,50.0 mg/ml (50,000 ppm) >240 min.
Paclitaxel,6.0 mg/ml (6,000 ppm) >240 min.
Carmustine (BCNU) 3.3 mg/ml (3,300 ppm), 38.7 min.
ThioTepa10.0 mg/ml (10,000 ppm), 56.9 min
Please note that the following drug has low permeation times of less than 60 minutes:
Carmustine (BCNU) 3.3 mg/ml (3,300 ppm), 38.7minutes
ThioTepa10.0 mg/ml (10.000 ppm),56.9 minutes
WARNING: Do not use Carmustine and Thiotepa

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This is an FDA 510(k) clearance letter for Disposable Medical Nitrile Examination Gloves -Tested for Use with Chemotherapy Drugs. It's a Class I reserved device and, as such, the provided information does not describe an AI/ML device but rather a physical device (gloves). Therefore, many of the requested criteria regarding AI/ML study design are not applicable.

Here's the relevant information that can be extracted from the provided text, focusing on the device's performance regarding chemotherapy drug resistance:

Acceptance Criteria and Device Performance for Chemotherapy Drug Permeation

The acceptance criteria are implicitly defined by the test results indicating "NO breakthrough detected up to 240 minutes" for most listed chemotherapy drugs, in accordance with ASTM D6978-05(2019). For drugs with breakthrough times below 240 minutes, those times are reported, along with a warning for those under 60 minutes.

Important Note: The document explicitly warns against using the gloves with Carmustine and ThioTepa due to their low permeation times (less than 60 minutes).

The following points are not applicable to this device as it is a physical medical device (examination gloves) and not an AI/ML powered diagnostic or therapeutic device. The requested information pertains to studies typically conducted for AI/ML performance evaluation.

2. Sample size used for the test set and the data provenance: Not applicable. This refers to physical material testing, not data analysis.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Material testing to a standard like ASTM D6978-05(2019) involves laboratory procedures, not expert consensus on medical images or diagnoses.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): The "ground truth" used here is the physical barrier performance of the glove against specific chemical permeation, determined according to the standardized laboratory methods described in ASTM D6978-05(2019). This is a scientific, objective measurement, not based on expert consensus or clinical outcomes for diagnosis.
8. The sample size for the training set: Not applicable. This concept is for AI/ML models.
9. How the ground truth for the training set was established: Not applicable.

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Disposable Medical Synthetic Nitrile Examination Gloves are disposable device intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner.

Disposable Medical Synthetic Nitrile Examination Gloves

The provided text is a U.S. Food and Drug Administration (FDA) 510(k) clearance letter for "Disposable Medical Synthetic Nitrile Examination Gloves." This document does not describe acceptance criteria for an AI/ML device or a study proving its performance.

Instead, it's a regulatory clearance for a physical medical device (gloves), confirming its substantial equivalence to previously marketed devices. The content focuses on regulatory compliance, such as registration, labeling, manufacturing practices, and adverse event reporting for this type of conventional device.

Therefore, I cannot extract the information required to answer your questions about acceptance criteria and a study proving the device meets those criteria, as no such information is present in the provided text. The questions you've posed (regarding tables of acceptance criteria, sample sizes, expert ground truth, MRMC studies, standalone performance, etc.) are relevant to the evaluation of AI/ML medical devices, not to the clearance of examination gloves.

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The Nitrile Examination Gloves are non-sterile disposable devices intended for medical purposes that are worn on the examiner's hands or finger to prevent contamination between patient and examiner.

Nitrile Examination Gloves are patient examination gloves made from nitrile compound, non-sterile (as per 21 CFR 880.6250, Class I). The principle operation of the medical device to provide single use barrier protection for the wearer and the device meets all the requirements specifications for barrier protection, tensile properties as defined in ASTM D6319-10, Standard specification for Nitrile Examination Gloves. The subject device is powder free nitrile examination gloves. The subject device is in blue color.

This document is a 510(k) Pre-Market Notification for Nitrile Examination Gloves (K210706). It reports on non-clinical testing to demonstrate substantial equivalence to a predicate device.

1. Table of Acceptance Criteria and Reported Device Performance

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