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510(k) Data Aggregation
(44 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.
Classified by FDA's General and Plastic Surgery Device panel as Class I, 21 CFR 880.6250, Patient Examination Glove, 80LZA, and meets all requirements of ASTM Standard D6319-00aE3.
The provided text is a 510(k) summary for a medical device: "Syntex Powder-Free Nitrile Examination Glove, Tested for Chemotherapy." Based on the provided document, the device is a Class I patient examination glove. The document describes non-clinical tests to demonstrate substantial equivalence to a predicate device.
Here's an analysis of the acceptance criteria and study information provided in the document:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria / Standard | Reported Device Performance |
|---|---|
| Physical and Dimensions Testing: | |
| ASTM-D-6319-00aE3 (General Glove Standard) | "All testing meets requirements for Physical and Dimensions Testing conducted on gloves, Inspection Level S-2, AOL 4.0." And "Syntex Healthcare Products Co., Ltd. Syntex Powder-Free Nitrile Examination Glove, Tested for Chemotherapy conform fully to ASTM-D-6319-00a€3 standard..." |
| Pinhole / Water Leak Test: | |
| FDA 1000 ml. Water Fill Test (AQL 2.5, Inspection Level G-1) | "The FDA 1000 ml. Water Fill Test was also conducted with samplings of AQL 2.5, Inspection Level G-1, meeting these requirements." And "...meets pinhole FDA requirements." |
| Biocompatibility (Skin Irritation/Sensitization): | |
| Primary Skin Irritation and Skin Sensitization testing | "Primary Skin irritation and Skin Sensitization (allergic contact dermatitis) testing was conducted with results showing no primary skin irritant or sensitization reactions." And "...biocompatibility requirements..." |
| Powder Residue (for "powder-free" claim): | |
| ASTM D6124-01 for Starch (no more than 2 mg powder per glove) | "A Residual Powder Test that based on ASTM D6124-01 for Starch at finished inspection is conducted to insure that our gloves meet our "powder-free' claims (contain no more than 2 mg powder per glove)." |
| Chemotherapy Permeation (Implied based on device name, but not explicitly detailed in the summary) | The device is named "Tested for Chemotherapy," implying specific testing for this use. However, the 510(k) summary does not explicitly detail the acceptance criteria or results for chemotherapy permeation testing. It only states that the device "conform[s] fully to ASTM-D-6319-00a€3 standard as well as applicable 21 CFR references, and, meets pinhole FDA requirements. biocompatibility requirements and labeling claims as shown by data in Section 7." The lack of specific details for chemotherapy testing in Section 7 (Discussion of Non-Clinical tests) and Section 8 (Discussion of Clinical Tests) is a notable omission in this summary regarding the "Tested for Chemotherapy" aspect. |
2. Sample Size Used for the Test Set and the Data Provenance
- Physical and Dimensions Testing: Inspection Level S-2, AQL 4.0. (This refers to a sampling plan for quality control rather than a specific sample size for a "test set" in an AI/Software context).
- FDA 1000 ml. Water Fill Test: AQL 2.5, Inspection Level G-1. (Again, a sampling plan for quality control).
- Biocompatibility (Skin Irritation/Sensitization), Residual Powder Test: No specific sample sizes are mentioned for these tests, only that testing was "conducted."
- Data Provenance: Not applicable in the context of this device (a physical glove). The tests are performed on manufactured gloves.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
This information is not applicable to this type of device (a physical examination glove). Ground truth in this context is established by physical measurements and laboratory analyses against defined standards, not by expert interpretation of data.
4. Adjudication Method for the Test Set
This information is not applicable to this type of device. Adjudication methods are typically used in studies involving human interpretation or subjective assessment.
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
This information is not applicable to this type of device. An MRMC study is relevant for AI-powered diagnostic tools where human readers (e.g., radiologists) use the AI for assistance. This device is a physical glove.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done
This information is not applicable to this type of device. "Standalone performance" refers to the performance of an algorithm without human intervention, which is not relevant for a physical glove.
7. The Type of Ground Truth Used
The ground truth for this device's performance is based on defined physical and chemical standards as outlined in relevant ASTM standards and FDA requirements. This includes:
- Physical dimensions and tensile strength (ASTM-D-6319-00aE3)
- Barrier integrity (FDA 1000 ml. Water Fill Test for pinholes)
- Biocompatibility (Primary Skin irritation and Skin Sensitization testing via laboratory methods)
- Powder content (ASTM D6124-01)
- (Implied: Chemotherapy permeation data based on the device name, but methods/results are not detailed in this summary).
8. The Sample Size for the Training Set
This information is not applicable to this type of device. Training sets are relevant for machine learning algorithms, not for physical products like gloves.
9. How the Ground Truth for the Training Set was Established
This information is not applicable to this type of device, as it does not involve a training set for an algorithm.
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(67 days)
A powder-free patient examination glove is a disposable device made of natural rubber latex that may bear a trace amount of glove powder and is intended to be worn on the hand or finger(s) for medical purposes to provide a barrier against potentially infectious materials and other contaminants.
Syntex Powder-Free Latex Examination Gloves - Blue Color. A powder-free patient examination glove is a disposable device made of natural rubber latex that may bear a trace amount of glove powder.
The provided text is a scanned FDA 510(k) clearance letter for "Syntex Powder-Free Latex Examination Gloves". This document pertains to the regulatory clearance of a medical device based on substantial equivalence to a predicate device, rather than a study proving performance against specific acceptance criteria.
The letter explicitly states: "We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976..."
Therefore, the document does not contain the information requested regarding acceptance criteria, reported device performance, study details (sample size, data provenance, expert ground truth, adjudication methods, MRMC studies, standalone performance), or information about training sets for an AI/algorithm-based device.
The questions are designed for a scenario where an AI or algorithm-based device undergoes performance evaluation and validation, which is not the subject of this 510(k) clearance for a physical medical product like examination gloves.
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(83 days)
A patient examination glove is a disposable device intended for medical purpose that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.
Powder-Free Nitrile Examination Glove -- Purple Color
The provided document is a 510(k) clearance letter from the FDA for a device called "Syntex Powder-Free Nitrile Examination Glove, Purple Color." This document does not contain information about acceptance criteria, device performance studies, sample sizes, expert ground truth establishment, or any details related to AI or comparative effectiveness studies.
The letter explicitly states that the device is "substantially equivalent" to legally marketed predicate devices. This means that the FDA has determined the new device is as safe and effective as a device already on the market, based on its indications for use, technological characteristics, and performance data. However, the performance data itself, including specific acceptance criteria and study results, is typically found in the 510(k) submission summary, which is not part of this letter.
Therefore, I cannot provide the requested information from this document.
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(68 days)
A glove is worn on the hand of healthcare worker and similar personnel to prevent contamination between healthcare personnel and the patient's body, fluids, waste or environment.
Syntex Powder-Free Latex Examination Glove
I am sorry, but based on the provided text, I cannot extract the information required to describe the acceptance criteria and the study proving the device meets them. The document is a 510(k) premarket notification letter from the FDA to Syntex Healthcare Product Company Limited regarding their "Syntex Powder-Free Latex Examination Glove".
This letter confirms that the device has been found substantially equivalent to a legally marketed predicate device and can be marketed. However, it does not include details about:
- Acceptance criteria: There is no table of specific performance metrics or a detailed description of what constitutes "acceptance."
- Reported device performance: The letter does not contain any test results, data, or performance statistics for the Syntex glove.
- Study details: There is no mention of a specific study, its design, sample sizes, data provenance, expert involvement, adjudication methods, MRMC studies, standalone performance, or how ground truth was established for either training or test sets.
The letter primarily focuses on the regulatory decision of substantial equivalence and general compliance requirements. To answer your request, I would need a different type of document, such as a summary of safety and effectiveness data (SSD), a clinical study report, or a more detailed 510(k) submission document that typically includes performance data.
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(68 days)
A glove is worn on the hand of healthcare worker and similar personnel to prevent contamination between healthcare personnel and the patient's body, fluids, waste or environment.
Pre-Powdered Nitirile Examination Glove
I am sorry, but based on the provided text, there is no information about acceptance criteria, device performance, or any studies conducted to prove the device meets acceptance criteria. The text provided is an FDA clearance letter for a medical device (Syntex Pre-Powdered Nitrile Examination Glove), outlining its substantial equivalence to a predicate device and regulatory compliance. It does not contain details about specific performance metrics or studies.
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(63 days)
A patient examination glove is a disposable device intended for medical purpose that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.
Powder-Free Polymer-Coated Latex Examination Glove
This document is a 510(k) premarket notification letter for a Syntex Powder-Free Polymer-Coated Latex Examination Glove. It is from the FDA to Syntex Healthcare Products Co Ltd. and states that the device is substantially equivalent to legally marketed predicate devices.
This document does not contain any information about acceptance criteria or a study proving the device meets acceptance criteria. It is a regulatory approval letter based on substantial equivalence, not a performance study report.
Therefore, I cannot provide the requested table or answer any of the questions about a performance study, sample sizes, ground truth, or expert qualifications based on the provided text.
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(68 days)
A patient examination glove is a disposable device intended for medical purpose that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.
Syntex Pre-Powdered Latex Examination Glove
The provided text is a FDA 510(k) clearance letter for a medical device: "Syntex Pre-Powdered Latex Examination Glove."
This type of document does not contain the detailed technical information requested about acceptance criteria and study designs that prove device performance.
FDA 510(k) clearances are based on demonstrating substantial equivalence to a predicate device, not necessarily on new, extensive clinical studies proving efficacy or specific performance metrics in the way a PMA (Premarket Approval) would.
Therefore, I cannot provide the requested information from the given input. The letter essentially states that the device is "substantially equivalent" for its indicated use based on the information provided in the 510(k) submission, and it lists various regulatory requirements for the manufacturer.
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(42 days)
A glove is worn on the hand of healthcare worker and similar personnel to prevent contamination between healthcare personnel and the patient's body, fluids, waste or environment.
Powder-Free Multi-Ply Latex Examination Gloves With Protein Labeling Claim ( 50 Micrograms or Less )
I am sorry, but based on the provided document, I cannot extract the information required to answer your request. The document is a 510(k) premarket notification letter from the FDA regarding "Powder-Free Multi-Ply Latex Examination Gloves With Protein Labeling Claim (50 Micrograms or Less)."
This document primarily focuses on the regulatory approval of a medical device (examination gloves) and does not contain details about:
- Acceptance criteria and reported device performance in a table format.
- Specific studies, sample sizes, data provenance, ground truth establishment, or expert qualifications.
- Adjudication methods or multi-reader multi-case (MRMC) comparative effectiveness studies.
- Standalone algorithm performance or training set details.
The document is a letter confirming substantial equivalence to a predicate device, which is a regulatory pathway for certain medical devices, rather than a detailed study report.
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(42 days)
A glove is worn on the hand of healthcare worker and similar personnel to prevent contamination between healthcare personnel and the patient's body, fluids, waste or environment.
Powder-Free Latex Examination Glove with Protein Labeling Claim ( 50 Micrograms or Less )
This document is a 510(k) clearance letter from the FDA for a Powder-Free Latex Examination Glove with Protein Labeling Claim (50 Micrograms or Less).
Unfortunately, this type of document is not relevant to the request of describing acceptance criteria and a study proving a device meets those criteria for an AI/ML medical device.
Here's why:
- Device Type: This document pertains to a physical medical device (examination gloves), not an AI/ML software device.
- Regulatory Pathway: The 510(k) pathway for traditional medical devices primarily focuses on demonstrating substantial equivalence to a legally marketed predicate device, often through performance testing on physical attributes (e.g., tensile strength, barrier integrity, protein content for allergies). It does not typically involve the kinds of clinical performance studies (e.g., diagnostic accuracy, sensitivity, specificity) that are foundational to AI/ML device evaluations.
- Missing Information: The letter itself only confirms the clearance and does not detail the specific test methods, acceptance criteria, or study designs used to support the substantial equivalence claim for the glove. It references a "Protein Labeling Claim," implying tests were done for protein content, but no specifics are provided.
Therefore, I cannot extract the requested information (acceptance criteria table, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, training set details) from this document as it simply isn't present or relevant to an AI/ML context.
To provide the requested information, I would need a document that describes the clinical validation or performance study for an AI/ML-based medical device.
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(56 days)
A glove is worn on the hand of healthcare worker and similar personnel to prevent contamination between healthcare personnel and the patient's body, fluids, waste or environment.
Syntex Powder-Free Polymer-Coated Nitrile Examination Gloves
This document is a 510(k) premarket notification letter from the FDA regarding "Syntex Powder-Free Polymer-Coated Nitrile Examination Gloves." It confirms the device's substantial equivalence to legally marketed predicate devices and permits its marketing.
The request for "acceptance criteria and the study that proves the device meets the acceptance criteria" is not applicable to this document. This letter is an FDA clearance, not a study report. It does not contain information about:
- A table of acceptance criteria and the reported device performance: This document does not detail specific performance criteria or test results.
- Sample size used for the test set and the data provenance: No test set details are provided.
- Number of experts used to establish the ground truth...: This is irrelevant to an FDA clearance letter for examination gloves.
- Adjudication method: Not applicable.
- Multi reader multi case (MRMC) comparative effectiveness study: Not applicable.
- Standalone (i.e. algorithm only without human-in-the-loop performance) study: Not applicable, as this is a physical medical device (gloves), not an AI algorithm.
- The type of ground truth used: Not applicable.
- The sample size for the training set: Not applicable.
- How the ground truth for the training set was established: Not applicable.
The document indicates that the device is "substantially equivalent" to legally marketed predicate devices. For examination gloves, this typically means demonstrating performance parameters (like barrier integrity, tensile strength, freedom from pinholes) that meet recognized consensus standards (e.g., ASTM standards) to be as safe and effective as existing gloves on the market. However, the details of these tests and their results are not present in this specific FDA clearance letter. Such information would be found in the 510(k) submission itself, not in the clearance letter.
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