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510(k) Data Aggregation
(175 days)
Natural Rubber Late: a non-colored, single use amination ce inte on the hand of med nded to If to prevent contamination between the patie neand examine
POWDERED LATEX EXAMINATION GLOVES (NON-COLORED)
The provided text is an FDA 510(k) clearance letter for Powdered Latex Examination Gloves (Non-Colored). It does not contain any information about acceptance criteria or a study proving the device meets acceptance criteria in the context of an AI/ML medical device.
The document is a regulatory communication confirming that the device is substantially equivalent to legally marketed predicate devices. It outlines general controls, manufacturing practices, and reporting requirements for the device.
Therefore, I cannot provide the requested information based on the given input text.
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(39 days)
A palient examination glove is a disposable device intended for medical purpose that is worn on examiner's hand to prevent contamination between patient and examiner.
Powdered Latex Examination Gloves
This document is a marketing authorization letter for "Powdered Latex Examination Gloves" and does not contain information about the acceptance criteria or a study proving a device meets them.
The letter is from the FDA to PT. Shamrock Manufacturing Corporation, confirming that their gloves are substantially equivalent to legally marketed predicate devices. It discusses regulatory compliance and marketing permissions.
Therefore, I cannot provide the requested information.
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(43 days)
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 purpos patient and examiner.
POWDERED LATEX EXMAINATION GLOVES
The provided text is a 510(k) premarket notification letter from the FDA regarding "Powdered Latex Examination Gloves." This document primarily addresses regulatory approval and does not contain the detailed technical study information typically found in a device's performance evaluation.
Therefore, I cannot extract the requested information regarding acceptance criteria and study details from the provided text. The document confirms market clearance based on substantial equivalence to a predicate device, but it does not include performance data, ground truth establishment, sample sizes, or expert adjudication methods.
Summary of what cannot be provided from the given text:
- Table of acceptance criteria and reported device performance: Not present. The letter is a regulatory approval, not a performance report.
- Sample size for the test set and data provenance: Not present.
- Number of experts and qualifications for ground truth: Not present.
- Adjudication method for the test set: Not present.
- Multi-reader multi-case (MRMC) comparative effectiveness study information: Not applicable or present. This device is a physical glove, not an AI or imaging device where MRMC studies are common.
- Standalone (algorithm only) performance information: Not applicable or present.
- Type of ground truth used: Not applicable or present.
- Sample size for the training set: Not applicable or present.
- How ground truth for the training set was established: Not applicable or present.
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(16 days)
A patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hands or finger to prevent contamination between patient and examiner.
Class 1 Latex Patient Examination Glove 80LYY, powdered with absorbable dusting powder, which meets all the requirements of ASTM Standard D3578-01a52 and FDA Water Leak Test.
The provided text describes the acceptance criteria and performance data for Powdered Latex Examination Gloves manufactured by SPI GLOVES SDN. BHD. This document is a 510(k) premarket notification for a medical device.
Please note that this document is for a physical product (gloves) and not an AI/ML powered device, so several of the requested categories (like MRMC study, effect size, human-in-the-loop, etc.) are not applicable and will be marked as "N/A".
1. A table of acceptance criteria and the reported device performance
| TEST | Acceptance Criteria (ASTM D3578-01aE2) | Reported Device Performance (Powdered Latex Exam Gloves) |
|---|---|---|
| 1. Watertight (1000 ml) | AQL=2.5% | Pass GI (AQL=2.5%) |
| 2. Length (mm) | Min 230 | 240 mm minimum for all sizes |
| 3. Palm width (mm) | ||
| Size XS | - | 110 mm |
| 4. Thickness (mm) (Single Layer) | ||
| Finger | Min 0.08 | 0.10 minimum |
| Palm | Min 0.08 | 0.10 minimum |
| 5. Physical Properties Before Aging | ||
| Tensile Strength (Mpa) | Min 14.0 | 28.0 |
| Ultimate Elongation (%) | Min 650 | 982 |
| 5. Physical Properties After Aging | ||
| Tensile Strength (Mpa) | Min 14.0 | 26.9 |
| Ultimate Elongation (%) | Min 500 | 970 |
| 6. Powder Content | - (FDA Requirement) | Below 10 mg / dm2 |
| 7. Protein Content | - (FDA Requirement) | Below 200 microgram / dm2 |
| 8. Biocompatibility Test | Pass | Pass (Primary Dermal Irritation Test, Guinea Pig Sensitization) |
2. Sample size used for the test set and the data provenance
The document does not explicitly state a specific sample size for the tests. The performance data is reported as meeting the standards, implying that adequate samples were tested for each criterion according to ASTM D3578-01aE2 and FDA requirements. The data provenance is from Malaysia (SPI GLOVES SDN. BHD. is located in Ipoh, Perak, Malaysia). The data appears to be prospective as it represents the performance testing conducted by the manufacturer for their product prior to submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
N/A. This is a physical product (gloves) undergoing standardized physical and chemical tests, not an AI/ML device requiring expert interpretation of medical images or data. The "ground truth" is defined by the objective measurement standards of ASTM D3578-01aE2 and FDA requirements.
4. Adjudication method for the test set
N/A. The testing involves objective measurements against established technical standards (ASTM D3578-01aE2) and FDA requirements. There is no human adjudication process described beyond the performance of the specified tests.
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
N/A. This is not an AI/ML powered device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
N/A. This is not an AI/ML powered device.
7. The type of ground truth used
The ground truth is established by objective technical standards and regulatory requirements:
- ASTM D3578-01aE2 Standard: This is a widely recognized standard specification for rubber examination gloves. It defines the acceptable ranges for physical properties like dimensions, tensile strength, elongation, and watertightness.
- FDA Water Leak Test: A specific FDA requirement for glove watertightness.
- FDA Minimum Powder Residual Content: A specific FDA requirement regarding the amount of powder on the gloves.
- Biocompatibility Tests: Standardized tests (Primary Dermal Irritation Test and Guinea Pig Sensitization (Buehler) test) to assess the biological response to the glove material.
8. The sample size for the training set
N/A. This is a manufactured product, not an AI/ML model that requires a training set.
9. How the ground truth for the training set was established
N/A. This is a manufactured product, not an AI/ML model that requires a training set or its associated ground truth establishment.
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(114 days)
A patient Examination Gloves is a disposable device intended for medical purposes that is worn on the examiner's hand or fingers to prevent contamination between patient and examiner.
Powdered Latex Examination Gloves Contains 200 microgram or less of total water Extractable Protein per gram
The provided text is a letter from the FDA regarding a 510(k) premarket notification for "Powdered Latex Examination Gloves." This document does not contain information about software as a medical device (SaMD), AI/ML, or the specific types of studies, metrics, and acceptance criteria normally associated with such devices.
Therefore, I cannot extract the requested information regarding acceptance criteria, study details, sample sizes, expert qualifications, or ground truth establishment. This document pertains to a physical medical device (gloves) and its regulatory clearance based on substantial equivalence to predicate devices, not performance metrics derived from a study comparing algorithms or human readers.
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(35 days)
Powdered Latex Examination Gloves are worn on the hands of health care and Formilar personnel to prevent contamination between health care personnel and the patient.
Not Found
This document is a 510(k) clearance letter from the FDA for "Powdered Latex Examination Gloves." It is a regulatory document and does not contain any information about acceptance criteria, study details, or device performance metrics typically associated with AI/ML-based medical devices.
Therefore, I cannot provide the requested information. The document focuses on regulatory approval based on substantial equivalence to a predicate device, not on quantitative performance parameters or clinical study results as asked in your prompt.
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(15 days)
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.
Powdered Latex Examination Gloves Without Protein Content Labelling Claim
This document is correspondence from the FDA regarding a 510(k) premarket notification for Powdered Latex Examination Gloves. It is not a study report or clinical trial. Therefore, none of the requested information regarding acceptance criteria, device performance, study details, or ground truth can be extracted from this document.
The document only states that the device is substantially equivalent to legally marketed predicate devices and can be marketed subject to general controls. It does not contain any data on device performance or studies conducted to establish its effectiveness or safety beyond demonstrating substantial equivalence.
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(37 days)
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(189 days)
The patient examination gloves is a disposable device intended for medical and dental purposes that is worn on the hand of healthcare and similar personnel to prevent contamination between healthcare personnel and the patient.
Powdered Latex Examination Gloves with Protein Content Labeling Claim of 200 micrograms or less.
This looks like a 510(k) clearance letter for a medical device (Powdered Latex Examination Gloves). This type of document does not typically contain the detailed information about acceptance criteria and clinical study results that you are requesting.
A 510(k) submission primarily demonstrates substantial equivalence to a predicate device, often relying on performance data rather than extensive clinical efficacy studies. The letter confirms the device is cleared for market based on this substantial equivalence.
Therefore, I cannot extract the following information from the provided text:
- A table of acceptance criteria and the reported device performance: This letter doesn't specify numeric acceptance criteria or detailed performance metrics.
- Sample sized used for the test set and the data provenance: Not present in this document.
- Number of experts used to establish the ground truth... and qualifications: Not present.
- Adjudication method: Not present.
- Multi reader multi case (MRMC) comparative effectiveness study: Not mentioned.
- Standalone (i.e. algorithm only without human-in-the-loop performance) study: Not applicable as this is a physical medical device.
- The type of ground truth used: Not applicable in this context.
- Sample size for the training set: Not applicable.
- How the ground truth for the training set was established: Not applicable.
The 510(k) "Indications for Use" section (provided as {2} in your input) only states:
- Device Name: Powdered Latex Examination Gloves with Protein Content Labeling Claim of 200 micrograms or less.
- Indications For Use: The patient examination gloves is a disposable device intended for medical and dental purposes that is worn on the hand of healthcare and similar personnel to prevent contamination between healthcare personnel and the patient.
To find the information you're looking for, you would typically need to review the full 510(k) submission summary or the actual performance data submitted by the manufacturer, which are not included in this FDA clearance letter.
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(56 days)
A patient Examination Glove is a disposable device intended for medical purpose that is worn on the examiner's hand or finger to pervent contamination between patient and examiner.
Powdered Latex Examination Gloves (Protein Label Claim) (50 microgram or less)
The provided text is a letter from the FDA regarding a 510(k) premarket notification for "Powdered Latex Examination Gloves." This letter grants market clearance based on a determination of substantial equivalence to a predicate device.
It does not contain information about acceptance criteria, device performance results, sample sizes for testing or training, ground truth establishment, expert qualifications, or details of a study that proves the device meets acceptance 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 is a regulatory clearance based on substantial equivalence, not a detailed description of an efficacy or performance study. Therefore, I cannot generate the requested information based on the provided text.
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