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A powder-free patient examination glove is a disposable device intended for medical purposes worn on the examiner's hand or finger to prevent contamination between patient and examiner

Latex Examination Gloves Powder-Free (Black Color) and with protein content labeling claim(50 micrograms or less)

This document is a 510(k) premarket notification determination letter from the FDA for "Latex Examination Gloves Powder-Free (Black Color) and with Protein Content Labeling Claim (50 micrograms or less)". It does not contain information about acceptance criteria or a study that proves the device meets specific acceptance criteria in the context of performance metrics like accuracy, sensitivity, or specificity.

Instead, the letter confirms that the device is "substantially equivalent" to legally marketed predicate devices. This means the FDA found that the new device is as safe and effective as a previously cleared device. The "acceptance criteria" in this context would primarily pertain to compliance with FDA regulations, good manufacturing practices, and performance characteristics (like protein content, physical properties such as tensile strength and elongation, and freedom from holes) that demonstrate substantial equivalence to predicate devices, rather than a statistical study proving clinical performance of an AI/ML diagnostic tool.

Therefore, I cannot provide the requested information from the provided text as it is not present in this type of FDA document.

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A patient examination glove is a NON STERILE disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner

NITRILE EXAMINATION GLOVES POLYMER COATED (WHITE, BLUE and BLACK COLOR)

The provided document is a 510(k) premarket notification letter from the FDA to Innovative Gloves Company, Limited, concerning Nitrile Examination Gloves. It primarily addresses the regulatory approval process and states that the device is substantially equivalent to legally marketed predicate devices.

This document does NOT contain information about:

• Acceptance criteria table or reported device performance for an AI/ML device.
• Sample sizes, data provenance, or details about test datasets.
• Number or qualifications of experts, or adjudication methods for ground truth establishment.
• Multi-reader multi-case (MRMC) comparative effectiveness studies or effect sizes.
• Standalone algorithm performance studies.
• Type of ground truth used (e.g., pathology, outcomes data).
• Training set sample size or how its ground truth was established.

Therefore, I cannot provide the requested information based on the provided text. The document is about the regulatory approval of medical gloves, not a study validating an AI/ML medical device.

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A powder free patient examination glove is a disposable device made of synthetic Nitrile butadiene rubber later material may bear a trace of glove powder and is intended to be worn on the hand for medical purposes to provide a barrier against potentially infectious material and other contaminants.

Black Nitrile Powder-Free Medical Examination Glove is a disposable device intended for medical purposes; that is worn on the examiner's hand, to prevent contamination between the patient and examiner.

The document describes the acceptance criteria and performance data for Innovative Gloves Company Limited's Nitrile Examination Gloves Powder-Free (Black Color).

This is a premarket notification (510(k)) submission, which typically focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than conducting extensive de novo clinical trials with independent ground truth establishment or MRMC studies. The "study" here refers to the testing performed against recognized standards.

Here's the breakdown of the information requested:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size: The document does not explicitly state the sample sizes used for each specific test (e.g., number of gloves tested for pinholes, number of participants for skin irritation). It only states that the device "Meets" the specified standards. ASTM and ISO standards for medical gloves typically specify sampling plans and test methods, but the raw data or detailed sample sizes are not provided in this summary.
• Data Provenance: The tests were conducted by Innovative Gloves Company Limited, based in Thailand. The data is retrospective in the sense that it was generated prior to the 510(k) submission to demonstrate compliance with the relevant standards.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

• This is not applicable in the context of this device and report. The "ground truth" here is adherence to established international and national standards (ASTM and ISO) for physical properties and biocompatibility. There isn't an "expert consensus" in the way one would establish ground truth for an AI diagnostic algorithm for image interpretation. The standards themselves define the criteria for "ground truth" performance.

4. Adjudication Method for the Test Set

• Not applicable. The tests are laboratory-based and objective measurements against established standard specifications, not subjective assessments requiring adjudication by multiple experts.

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

• No, an MRMC comparative effectiveness study was not done. This device is a medical glove, not an AI-assisted diagnostic tool for which MRMC studies are typically performed.

6. Standalone (Algorithm Only Without Human-in-the Loop Performance) Study

• Not applicable. This device is a physical product (a glove), not an algorithm.

7. Type of Ground Truth Used

• The ground truth for this device's performance is established by the specifications and methodologies outlined in the referenced international standards (ASTM D 6319-00a and ISO 10993, Part 10:2002(E)). These standards define acceptable ranges for dimensions, physical properties, pinhole freedom, powder content, and biological reactivity.

8. Sample Size for the Training Set

• Not applicable. This device is a physical product, not an AI model that requires a training set. The manufacturing process is controlled, and quality control tests (which are the "performance" data here) are done on samples from production batches.

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

• Not applicable, as there is no training set for a physical medical device like a glove.

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A patient examination glove is a disposable device intend for medical purpose that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.

BLUE NITRILE EXAMINATION GLOVES, POWDER FREE.

The provided document is a 510(k) clearance letter from the FDA for medical examination gloves. It does not contain information about acceptance criteria or a study proving that a device meets such criteria, as it pertains to AI/ML or a more complex medical device. Instead, it confirms that the Nitrile Examination Gloves Powder Free (Blue Color) are substantially equivalent to legally marketed predicate devices.

Therefore, I cannot provide the requested information based on the given text. The document is primarily an administrative letter about regulatory approval for a low-risk medical device (patient examination gloves).

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A patient examination glove is a disposable device intended for medical purpose than worn on the examiner's hands or fingers to prevent contamination between patient ar. examiner. (21 CER 880.6250)

LATEX EXAMINATION GLOVES POWDERFREE POLYMER COATED WITH PROTEIN CONTENT LABELING CLAIM ( 50 MICROGRAMS OF LESS)

This document is a 510(k) clearance letter for latex examination gloves. It does not contain information about the acceptance criteria or a study that proves a device meets such criteria for an AI/ML-driven medical device. Therefore, I cannot extract the requested information.

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A Medical glove is worn on the hand of health care and similar personnel to prevent contamination between health care personnel and patient.

Latex Examination Powder Free with proteins content label claim 50 MICROGRAMS OR LESS

This document is a 510(k) clearance letter from the FDA for "Innovative Gloves Latex Examination Gloves Trade Name: Powderfree With Protein Labeling Claim [50 Micrograms or Less]". It addresses the substantial equivalence of the device but does not contain acceptance criteria for performance, a study to prove acceptance criteria, or information on sample sizes, ground truth establishment, or expert involvement.

Therefore, I cannot fulfill your request for the specific information regarding acceptance criteria and study details. The document primarily confirms that the device is substantially equivalent to legally marketed predicate devices.

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A Medical glove is worn on the hand of health care and similar personnel to prevent contamination between health care personnel and patient.

LATEX EXAMINATION GLOVES, POWDERFREE

This document is an FDA 510(k) clearance letter for "Latex Examination Gloves Powderfree" from Innovative Gloves Company, Ltd. It does not contain information about the acceptance criteria or a study proving the device meets those criteria.

The letter explicitly states: "We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976..."

This means the device was cleared based on its substantial equivalence to a predicate device, not on a new study demonstrating its efficacy or performance against specific, new acceptance criteria. The clearance is based on the assumption that if it's substantially equivalent to a device already on the market, it meets the inherent safety and performance standards for that product type.

Therefore, I cannot provide the requested information from this document because it is not present. The document only confirms the FDA's decision regarding market clearance of the device.

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A Medical glc ve is worn on the hand of health care and similar personnel to prevent contamination between health care personnel and patient.

LATEX EXAMINATION GLOVES, PREPOWDERED

I am sorry, but the provided text is a letter from the FDA to a medical device company and an "Indications for Use" statement. It communicates that the company's "Latex Examination Gloves Prepowdered" have been determined to be substantially equivalent to devices marketed before 1976 and can therefore be marketed.

This document does not contain information about acceptance criteria, device performance, a study, sample sizes, data provenance, expert qualifications, adjudication methods, MRMC studies, standalone performance, or how ground truth was established, as your request asks for.

Therefore, I cannot fulfill your request based on the provided text.

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A Medical glove is worn on the hand of health care and similar personnel to prevent contamination between health care personnel and patient.

NITRILE LATEX EXAMINATION GLOVES, POWDERFREE

The provided text is a 510(k) premarket notification letter from the FDA to Innovative Gloves Company, Ltd. regarding their Nitrile Examination Gloves, Powderfree. This document does not contain information about acceptance criteria, device performance studies, sample sizes, expert qualifications, or ground truth establishment.

Instead, it's a regulatory approval letter stating that the device is substantially equivalent to legally marketed predicate devices and can be marketed subject to general controls. It references an "Indications for Use" enclosure (which is provided in the third image) but does not detail the technical performance or testing methodology.

Therefore, I cannot extract the requested information from the provided text because it is not present.

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