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This is a disposable device intended for medical application that is worn on the examiner's hand to prevent contamination between examiner and patient and to protect examiner from the following Chemotherapy drugs tested to ASTM D 6978 with the indicated Breakthrough Detection Times :
Chemotherapy Drug Permeation (Breakthrough Detection Time) in Minutes.
Nitrile Powder Free Examination Glove (Blue)

• CAUTION: Testing showed average breakthrough time of 40.00minutes with Carmustine.
  Nitrile Powder Free Examination Glove (Green)
• WARNING: DO NOT USE WITH CARMUTINE.
  Nitrile Powder Free Examination Glove (White)
• CAUTION: Testing showed average breakthrough time of 48.00minutes with Thio-Tepa.
• WARNING: DO NOT USE WITH CARMUTINE.

Non Sterile. Powder-Free. Nitrile Examination for Use with Chemotherapy Drugs

Here's an analysis of the provided information regarding the acceptance criteria and the study that proves the device meets them:

Device: Royal Guard Nitrile Examination Glove Tested For Use with Chemotherapy Drugs (Blue, Green, White)

1. Table of Acceptance Criteria and Reported Device Performance

Chemotherapy Drug Permeation (Breakthrough Detection Time in Minutes) - Section 14 Data:

Note on Chemotherapy Drug Permeation: The "acceptance criteria" for chemotherapy drug permeation are the results themselves, as they are being reported to define the specific capabilities of the gloves. The underlying standard for testing is ASTM D 6978-05. The document includes warnings for specific glove colors regarding certain chemotherapy drugs due to lower breakthrough times.

2. Sample Size and Data Provenance (for test set/performance data)

The document does not explicitly state the sample sizes used for each of the performance tests (Dimensions, Physical Properties, Freedom from Holes, Powder-Free Residue, Biocompatibility, and Chemotherapy Drug Permeation). It only says the testing "meets" the respective ASTM standards or criteria.

For Chemotherapy Drug Permeation, the data provenance is implicitly from laboratory testing conducted by the manufacturer or a contracted lab to meet ASTM D 6978-05. The country of origin for the manufacturing and potentially the testing is Thailand, as the submitter's address is in Thailand. Given the nature of these tests, they are inherently prospective for the device being submitted.

3. Number of Experts and Qualifications for Ground Truth

This information is not applicable as the device is a medical glove, and its performance is evaluated against engineering and chemical standards, not by expert interpretation of clinical data or images. Ground truth is established through objective physical and chemical testing.

4. Adjudication Method (for test set)

Not applicable. Adjudication methods (like 2+1, 3+1) are used for resolving disagreements among multiple experts in image interpretation or clinical diagnosis. This device's performance is determined by objective laboratory measurements against defined standards.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

Not applicable. This type of study evaluates the improvement in human reader performance (e.g., radiologists interpreting images) with or without AI assistance. The device is a physical medical glove, not an AI-powered diagnostic tool.

6. Standalone (Algorithm Only) Performance Study

Not applicable. The device is a physical glove, not an algorithm. Therefore, "standalone" performance in the context of an algorithm does not apply. The performance data presented (e.g., breakthrough times, physical properties) are inherent to the device itself.

7. Type of Ground Truth Used

The ground truth used for evaluating this device's performance is based on objective measurements and adherence to established industry standards.

• Engineering/Physical Standards: For dimensions, physical properties, freedom from holes, and powder-free residue, the ground truth is defined by the specifications and test methods outlined in ASTM D 6319-00a (2005) and ASTM D 6124-06.
• Biocompatibility Standards: For primary skin irritation and guinea pig sensitization, the ground truth is established by the results of standard animal testing protocols designed to assess biological response.
• Chemical Permeation Standard: For chemotherapy drug permeation, the ground truth is the experimentally determined breakthrough time as measured according to ASTM D 6978-05.

8. Sample Size for the Training Set

Not applicable. This device is not an AI/ML algorithm that requires a "training set." Its performance is based on physical and chemical properties.

9. How the Ground Truth for the Training Set was Established

Not applicable. As there is no training set for this type of device, this question is not relevant.

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The Non-Sterile, Powder-Free, Black Latex Examination Gloves, with Protein Labeling Claim (50 micrograms or less of total water extractable protein per gram of 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.

Non-Sterile, Powder-Free, Black Latex Examination Gloves, with Protein Labeling Claim (50 micrograms or less of total water soluble protein per gram of glove)

I am sorry, but the provided text does not contain information about acceptance criteria and a study that proves a device meets those criteria. The document is an FDA 510(k) clearance letter for "Non-Sterile, Powder Free, Black Latex Exam Gloves with Protein Labeling Claim."

The letter discusses the substantial equivalence determination for the gloves and states that the device meets the general controls provisions of the Act. It also mentions a protein labeling claim of "50 micrograms or less of total water soluble protein per gram of glove." However, it does not describe specific acceptance criteria in a table, nor does it detail a study performed to demonstrate meeting those criteria using the requested information points (sample size, data provenance, expert ground truth, adjudication, MRMC study, standalone performance, training set details, etc.).

Therefore, I cannot provide the requested information based on the given text.

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The Royal Guard Latex, Powder-Free, Surgeon's Glove - Sterile, is a device made of natural or synthetic rubber intended to be worn by operating room personnel to protect a surgical wound from contamination between patient and operating room personnel.

The Royal Guard Latex, Powder-Free, Surgeon's Glove - Sterile, is a device made of natural or synthetic rubber.

I am sorry, but the PDF provided does not contain the information requested. The document is a 510(k) premarket notification letter from the FDA regarding "Surgeon's Glove Powder Free" and does not include details about acceptance criteria, study designs, sample sizes, expert qualifications, or ground truth establishment relevant to an AI/device performance study.

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The powdered latex surgeon's glove with protein content labeling claim (200 micrograms or less per gram) is a device made of natural or synthetic rubber intended to be worn by operating room personnel to protect a surgical wound from contamination between patient and operating room personnel.

Powdered Latex Surgeon's Glove with Protein Content Labeling Claim (200 Micrograms or Less per Gram)

The provided text is a 510(k) clearance letter from the FDA for a powdered latex surgeon's glove. It does not contain any information about acceptance criteria or a study that proves a device meets such criteria.

The document primarily states that the FDA has reviewed the premarket notification and determined the device is "substantially equivalent" to legally marketed predicate devices. This is a regulatory determination, not a statement about specific performance metrics relative to acceptance criteria from a study.

Therefore, I cannot fulfill your request for:

1. A table of acceptance criteria and reported device performance.
2. Sample sizes or data provenance for a test set.
3. Number and qualifications of experts for ground truth.
4. Adjudication method.
5. MRMC comparative effectiveness study details.
6. Standalone performance details.
7. Type of ground truth used.
8. Sample size for the training set.
9. How ground truth for the training set was established.

This document pertains to the regulatory clearance of a physical medical device (gloves), not an AI/software device that would typically undergo the kind of performance studies described in your query.

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A patient examination glove is a disposable device intended for manuations . or er es that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.

POLYMER COATED, CHLORINATED POWDER-FREE LATEX EXAMINATION GLOVES WITH PROTEIN LABELING (less than 50 ug/g per glove)

The provided text is a 510(k) premarket notification approval letter for "Polymer Coated Chlorinated, Powder-Free Latex Examination Gloves with Protein Labeling (50 ug/g or Less)". It states that the device is substantially equivalent to a legally marketed predicate device.

However, this document does not contain information about acceptance criteria, specific device performance data, a study design, sample sizes, expert qualifications, or ground truth establishment relevant to the questions asked for a typical AI/ML medical device submission.

The text focuses on regulatory approval based on substantial equivalence, general controls, and compliance with federal regulations. It does not elaborate on a clinical performance study with specific metrics like sensitivity, specificity, or reader improvement, which are common for AI/ML device evaluations.

Therefore, I cannot fulfill the request for information regarding acceptance criteria, study details, and performance metrics as they are not present in the provided document.

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A 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

POLYMER COATED, POWDER-FREE LATEX EXAMINATION GLOVES WITH PROTEIN LABELING (less than 50 ug/g per glove)

I am sorry, but the provided text is a Food and Drug Administration (FDA) clearance letter for a medical device, specifically "Polymer Coated, Powder-Free Latex Examination Gloves with Protein Labeling."

This document does not contain the information required to answer your request about acceptance criteria and a study proving device performance.

The letter focuses on:

• Confirming that the device has been reviewed and determined to be substantially equivalent to a legally marketed predicate device.
• Outlining regulatory requirements and general controls provisions.
• Providing contact information for further guidance.
• Stating the intended use of the gloves.

There is no mention of:

• Specific acceptance criteria for performance.
• Any study data, sample sizes, data provenance.
• Expert involvement for ground truth, adjudication methods.
• Multi-reader multi-case (MRMC) studies or standalone algorithm performance.
• Training set details.

Therefore, I cannot generate the requested table or answer the specific questions based on the provided input.

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